Back to resultsPercutaneous Electrical Stimulation, Education and Exercise Program in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic exercise
Pain education
Percutaneous electrical stimulation
Transcutaneous electrical stimulation
Placebo stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Physiotherapy, Physical Therapy, Conditioned Pain Modulation, Temporal Summation of pain, Knee pain, PENS, Percutaneous electrical stimulation, Pain education
Eligibility Criteria
Inclusion Criteria: Age ≥ 45 years Have activity related joint pain Have morning stiffness ≤30 min Knee pain of at least 6 months duration OA diagnosis by physician Current levels of moderate/vigorous physical activity (MVPA) below physical activity guideline recommendations (< 150 min/week of MVPA; assessed using the Active Australia Physical Activity Questionnaire) Exclusion Criteria: Health conditions that prevent safe participation in physical activity interventions as listed in the American College of Sports Medicine Guidelines (e.g., cardiac or lung disease). Pain in other body areas that currently limits walking ability (e.g., back pain, foot pain, hip pain) Neurological disorders affecting lower limb movement (e.g., multiple sclerosis or stroke). Inflammatory arthritis (including rheumatoid arthritis) Fibromyalgia Previously operated knee is the most painful knee Any condition impacting decision-making/memory (e.g., Alzheimer's, dementia) Severe depression Current moderate/vigorous physical activity levels above guideline recommendations (≥150 min/week; assessed using the Active Australia Physical Activity Questionnaire) Currently undergoing regular, active intervention for the knee (e.g., seeing a physiotherapist) Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)
Sites / Locations
- Universidad Rey Juan CarlosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Exercise, education and PENS
Exercise, education and TENS
Exercise, education and placebo stimulation
Arm Description
Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of percutaneous electrical stimulation (PENS).
Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of transcutaneous electrical stimulation (TENS).
Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of placebo stimulation.
Outcomes
Primary Outcome Measures
Change from baseline to one month in WOMAC
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to three months in WOMAC
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to six months in WOMAC
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to immediately after the first session in VAS
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to one month in VAS
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to three months in VAS
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to six months in VAS
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Secondary Outcome Measures
Change from baseline to immediately after the first session in PPT
Pressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from baseline to one month in PPT
Pressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from baseline to three months in PPT
Pressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from baseline to six months in PPT
Pressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from baseline to immediately after the first session in CPM
Conditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).
Change from baseline to one month in CPM
Conditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).
Change from baseline to three months in CPM
Conditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).
Change from baseline to six months in CPM
Conditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).
Change from baseline to immediately after the first session in TSP
Temporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Change from baseline to one month in TSP
Temporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Change from baseline to three months in TSP
Temporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Change from baseline to six months in TSP
Temporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Change from baseline to one month in TUG
The Timed Up and Go (TUG) Test is a test especially indicated to measure mobility and assess the risk of falls in the elderly. The patient will begin sitting in a chair with his back supported and his arms on the armrests, when he hears the word "Let's go" he must get up and walk to a mark that will be on the ground 3 meters away and finally the person will turn around and walk again to sit on the chair. The time it takes from when you say "Let's go" until he sits down again will be timed (3 attempts and the results are averaged).
Change from baseline to three months in TUG
The Timed Up and Go (TUG) Test is a test especially indicated to measure mobility and assess the risk of falls in the elderly. The patient will begin sitting in a chair with his back supported and his arms on the armrests, when he hears the word "Let's go" he must get up and walk to a mark that will be on the ground 3 meters away and finally the person will turn around and walk again to sit on the chair. The time it takes from when you say "Let's go" until he sits down again will be timed (3 attempts and the results are averaged).
Change from baseline to six months in TUG
The Timed Up and Go (TUG) Test is a test especially indicated to measure mobility and assess the risk of falls in the elderly. The patient will begin sitting in a chair with his back supported and his arms on the armrests, when he hears the word "Let's go" he must get up and walk to a mark that will be on the ground 3 meters away and finally the person will turn around and walk again to sit on the chair. The time it takes from when you say "Let's go" until he sits down again will be timed (3 attempts and the results are averaged).
Change from baseline to one month in GCPS
Pain severity will be assessed using the Spanish version of the Chronic Pain Grading Scale (GCPS). This scale is a self-reported instrument that consists of two subscales; the first assesses pain intensity, and the second assesses perceived disability. The scale is made up of a total of 8 items, 7 of which are 11 points in Likert format, and the other item assesses the perpetuation of pain, asking for the number of days of pain in the previous 6 months. The Spanish version of the GCPS has proven to be a valid and reliable instrument to assess the severity of chronic pain.
Change from baseline to three months in GCPS
Pain severity will be assessed using the Spanish version of the Chronic Pain Grading Scale (GCPS). This scale is a self-reported instrument that consists of two subscales; the first assesses pain intensity, and the second assesses perceived disability. The scale is made up of a total of 8 items, 7 of which are 11 points in Likert format, and the other item assesses the perpetuation of pain, asking for the number of days of pain in the previous 6 months. The Spanish version of the GCPS has proven to be a valid and reliable instrument to assess the severity of chronic pain.
Change from baseline to six months in GCPS
Pain severity will be assessed using the Spanish version of the Chronic Pain Grading Scale (GCPS). This scale is a self-reported instrument that consists of two subscales; the first assesses pain intensity, and the second assesses perceived disability. The scale is made up of a total of 8 items, 7 of which are 11 points in Likert format, and the other item assesses the perpetuation of pain, asking for the number of days of pain in the previous 6 months. The Spanish version of the GCPS has proven to be a valid and reliable instrument to assess the severity of chronic pain.
Baseline Mini-Mental Status
MEC is the spanish version of the Mini-Mental Status Examination. It is the most widely used cognitive screening test to assess suspected symptoms compatible with cognitive impairment or dementia. Through a series of questions and requests, different cognitive functions are evaluated: temporal and spatial orientation, immediate memory, information storage and retrieval, concentration and working memory, oral language, reading and writing a sentence and visoconstruction by copying a simple drawing.
Change from baseline to one month in STAI
The State-Trait Anxiety Inventory (STAI). This questionnaire comprises two subsections of 20 items each for the measurement of anxiety as a state and as a trait, with a 4-point Likert-type response (0: not at all; 3: very much). Scores range from 0 to 60 points, with higher scores indicating greater anxiety.
Change from baseline to three months in STAI
The State-Trait Anxiety Inventory (STAI). This questionnaire comprises two subsections of 20 items each for the measurement of anxiety as a state and as a trait, with a 4-point Likert-type response (0: not at all; 3: very much). Scores range from 0 to 60 points, with higher scores indicating greater anxiety.
Change from baseline to six months in STAI
The State-Trait Anxiety Inventory (STAI). This questionnaire comprises two subsections of 20 items each for the measurement of anxiety as a state and as a trait, with a 4-point Likert-type response (0: not at all; 3: very much). Scores range from 0 to 60 points, with higher scores indicating greater anxiety.
Change from baseline to one month in BDI-II
Beck Depression Inventory-II (BDI-II) is a self-report measure of depression in a variety of settings and populations. It is the most widely used questionnaire worldwide to assess depression. The total score ranges from 0 to 63 points. A change of 5 points corresponds to a minimally important clinical difference.
Change from baseline to three months in BDI-II
Beck Depression Inventory-II (BDI-II) is a self-report measure of depression in a variety of settings and populations. It is the most widely used questionnaire worldwide to assess depression. The total score ranges from 0 to 63 points. A change of 5 points corresponds to a minimally important clinical difference.
Change from baseline to six months in BDI-II
Beck Depression Inventory-II (BDI-II) is a self-report measure of depression in a variety of settings and populations. It is the most widely used questionnaire worldwide to assess depression. The total score ranges from 0 to 63 points. A change of 5 points corresponds to a minimally important clinical difference.
Change from baseline to one month in PCS
The Spanish version of the Pain Catastrophizing Scale (PCS) it has 13 items and each one is rated on a 5-point scale: 0 (not at all) to 4 (all the time). It comprises 3 dimensions: rumination, magnification, and despair. The theoretical range of the instrument is between 13 and 62, with low scores indicating low catastrophism and high values indicating high catastrophism.
Change from baseline to three months in PCS
The Spanish version of the Pain Catastrophizing Scale (PCS) it has 13 items and each one is rated on a 5-point scale: 0 (not at all) to 4 (all the time). It comprises 3 dimensions: rumination, magnification, and despair. The theoretical range of the instrument is between 13 and 62, with low scores indicating low catastrophism and high values indicating high catastrophism.
Change from baseline to six months in PCS
The Spanish version of the Pain Catastrophizing Scale (PCS) it has 13 items and each one is rated on a 5-point scale: 0 (not at all) to 4 (all the time). It comprises 3 dimensions: rumination, magnification, and despair. The theoretical range of the instrument is between 13 and 62, with low scores indicating low catastrophism and high values indicating high catastrophism.
Change from baseline to one month in TSK-11
Tampa Scale for Kinesiophobia (TSK-11) is an 11-item scale that assesses the degree of fear of movement and (re)injury. Each item is scored from 1 to 4 according to the degree of agreement with the statement (1: do not agree at all; 4: strongly agree). The validated Spanish version of the 11-item scale has a total score of 11 to 44 items and has two subscales: activity avoidance and harm.
Change from baseline to three months in TSK-11
Tampa Scale for Kinesiophobia (TSK-11) is an 11-item scale that assesses the degree of fear of movement and (re)injury. Each item is scored from 1 to 4 according to the degree of agreement with the statement (1: do not agree at all; 4: strongly agree). The validated Spanish version of the 11-item scale has a total score of 11 to 44 items and has two subscales: activity avoidance and harm.
Change from baseline to six months in TSK-11
Tampa Scale for Kinesiophobia (TSK-11) is an 11-item scale that assesses the degree of fear of movement and (re)injury. Each item is scored from 1 to 4 according to the degree of agreement with the statement (1: do not agree at all; 4: strongly agree). The validated Spanish version of the 11-item scale has a total score of 11 to 44 items and has two subscales: activity avoidance and harm.
Change from baseline to immediately after the first intervention in catastrophism in vivo
In vivo catastrophism. Questions will be asked regarding the types of thoughts and feelings of the patient while the painful stimulus was applied in the measurement of conditioned pain modulation. Using the a scale, you are asked to indicate the degree to which you had these thoughts and feelings during the pain test.
Change from baseline to one month in CRES-4
Consumer Reports Effectiveness Scale (CRES-4) consisting of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. Its global score is intended to reflect treatment effectiveness as perceived by the patient.
Change from baseline to three months in CRES-4
Consumer Reports Effectiveness Scale (CRES-4) consisting of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. Its global score is intended to reflect treatment effectiveness as perceived by the patient.
Change from baseline to six months in CRES-4
Consumer Reports Effectiveness Scale (CRES-4) consisting of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. Its global score is intended to reflect treatment effectiveness as perceived by the patient.
Change from baseline to one month in GROC
The Global Rating of Change Score (GRoC) is a frequently used outcome measure that has been used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores. The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter.
Change from baseline to three months in GROC
The Global Rating of Change Score (GRoC) is a frequently used outcome measure that has been used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores. The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter.
Change from baseline to six months in GROC
The Global Rating of Change Score (GRoC) is a frequently used outcome measure that has been used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores. The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter.
Baseline Demographic and Clinical Characteristics
Demographic information including sex, age, weight, height, pain duration, the mean and worse pain intensities during the last week using the Visual Analogue Scale will be collected.
Change from baseline to one month in SPPB
Short physical performance battery (SPPB). It makes it possible to classify the level of physical functioning of the elderly throughout the entire functional spectrum. It consists of carrying out three tests: balance (in three positions: feet together, semi-tandem and tandem), gait speed (4 meters) and getting up and sitting down on a chair five times.The total SPPB score and outcome assessment results from the sum of the three subtests, and ranges from 0 (worst) to 12; changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.
Change from baseline to three months in SPPB
Short physical performance battery (SPPB). It makes it possible to classify the level of physical functioning of the elderly throughout the entire functional spectrum. It consists of carrying out three tests: balance (in three positions: feet together, semi-tandem and tandem), gait speed (4 meters) and getting up and sitting down on a chair five times. The total SPPB score and outcome assessment results from the sum of the three subtests, and ranges from 0 (worst) to 12; changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.
Change from baseline to six months in SPPB
Short physical performance battery (SPPB). It makes it possible to classify the level of physical functioning of the elderly throughout the entire functional spectrum. It consists of carrying out three tests: balance (in three positions: feet together, semi-tandem and tandem), gait speed (4 meters) and getting up and sitting down on a chair five times. The total SPPB score and outcome assessment results from the sum of the three subtests, and ranges from 0 (worst) to 12; changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.
Change from baseline to one month in SF-12
The SF-12 Health Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. Generic patient-reported outcome measures like the SF-12 assess general health and well-being, including the impact of any and all illnesses on a broad range of functional domains. The response options form Likert-type scales (where the number of options varies from three to six points, depending on the item), which evaluate intensity and/or frequency of people's health status. The score ranges from 0 to 100, where the higher the score, the better the health-related quality of life.
Change from baseline to three months in SF-12
The SF-12 Health Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. Generic patient-reported outcome measures like the SF-12 assess general health and well-being, including the impact of any and all illnesses on a broad range of functional domains. The response options form Likert-type scales (where the number of options varies from three to six points, depending on the item), which evaluate intensity and/or frequency of people's health status. The score ranges from 0 to 100, where the higher the score, the better the health-related quality of life.
Change from baseline to six months in SF-12
The SF-12 Health Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. Generic patient-reported outcome measures like the SF-12 assess general health and well-being, including the impact of any and all illnesses on a broad range of functional domains. The response options form Likert-type scales (where the number of options varies from three to six points, depending on the item), which evaluate intensity and/or frequency of people's health status. The score ranges from 0 to 100, where the higher the score, the better the health-related quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05955430
Brief Title
Percutaneous Electrical Stimulation, Education and Exercise Program in Patients With Knee Osteoarthritis
Official Title
Efficacy of Percutaneous Electrical Stimulation Compared to Transcutaneous Electrical Stimulation in Combination With an Education and Exercise Program in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Josue Fernandez Carnero
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to compare the effectiveness of percutaneous electrotherapy treatment with transcutaneous and placebo.
Detailed Description
There is evidence of the benefit of therapeutic exercise on pain intensity and functionality in patients with osteoarthritis of the knee. However, there is a lack of evidence of its effectiveness when applied in combination with new treatment strategies such as percutaneous electrostimulation and therapeutic pain education.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, Physiotherapy, Physical Therapy, Conditioned Pain Modulation, Temporal Summation of pain, Knee pain, PENS, Percutaneous electrical stimulation, Pain education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise, education and PENS
Arm Type
Experimental
Arm Description
Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of percutaneous electrical stimulation (PENS).
Arm Title
Exercise, education and TENS
Arm Type
Active Comparator
Arm Description
Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of transcutaneous electrical stimulation (TENS).
Arm Title
Exercise, education and placebo stimulation
Arm Type
Placebo Comparator
Arm Description
Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of placebo stimulation.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Intervention Description
It consists of strengthening exercises and gradual walking. The lower limb strengthening exercises are individualized and progressive for each patient for twelve weeks. There will be eight face-to-face sessions over four weeks. And then the patient will continue with those exercises for eight more weeks. In addition, they must perform twelve weeks of progressive walking until they are walking at least 30 minutes, 5 days a week at a moderate intensity (defined as moderate shortness of breath while walking).
Intervention Type
Other
Intervention Name(s)
Pain education
Intervention Description
A therapeutic pain education program for patients will be implemented. There will be four 30-minute face-to-face sessions (one session per week). The objective is to change the participants' conceptualization of pain. From seeing pain as a marker of tissue damage to a marker of the body's perceived need for protection. Contents include basic structure of the nervous system, distinction between nociception and pain, peripheral and central sensitization, neuroplasticity and benefits of exercise.
Intervention Type
Other
Intervention Name(s)
Percutaneous electrical stimulation
Intervention Description
A TENS (100 Hz 100 ms) current will be applied through four needles located in the knee for 30 minutes. Eight sessions will be held during a month (two per week). The distribution of the channels will be for the first channel anode in lateral anterior zone and cathode in medial anterior zone and for the second channel anode in Hoffa's fat and cathode in goose foot. Participants will be able to adjust the amplitude to a strong and manageable sensory stimulation intensity that was not strong enough to cause muscle contraction.
Intervention Type
Other
Intervention Name(s)
Transcutaneous electrical stimulation
Intervention Description
A TENS (100 Hz 100 ms) current will be applied through four patches located in the knee for 30 minutes. Eight sessions will be held during a month (two per week). The distribution of the channels will be for the first channel anode in lateral anterior zone and cathode in medial anterior zone and for the second channel anode in Hoffa's fat and cathode in goose foot. Participants will be able to adjust the amplitude to a strong and manageable sensory stimulation intensity that was not strong enough to cause muscle contraction.
Intervention Type
Other
Intervention Name(s)
Placebo stimulation
Intervention Description
To perform the dry needling placebo, modified needles will be used according to the validation performed by Mitchell et al. 2018, since they generate more puncture sensation than normal needles, which has been shown to generate more analgesia and to be more effective as a placebo. To perform placebo TENS, the protocol established by Rakel et al. 2010 will be used, which consists of applying a TENS of 100 Hz and 100 ms for 30 seconds and then lowering the intensity during the following 15 seconds. Eight sessions will be held during a month (two per week).
Primary Outcome Measure Information:
Title
Change from baseline to one month in WOMAC
Description
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in WOMAC
Description
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in WOMAC
Description
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Time Frame
At baseline and at six months
Title
Change from baseline to immediately after the first session in VAS
Description
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Time Frame
At baseline and immediately after the first session
Title
Change from baseline to one month in VAS
Description
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in VAS
Description
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in VAS
Description
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Time Frame
At baseline and at six months
Secondary Outcome Measure Information:
Title
Change from baseline to immediately after the first session in PPT
Description
Pressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Time Frame
At baseline and immediately after the first session
Title
Change from baseline to one month in PPT
Description
Pressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in PPT
Description
Pressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in PPT
Description
Pressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Time Frame
At baseline and at six months
Title
Change from baseline to immediately after the first session in CPM
Description
Conditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).
Time Frame
At baseline and immediately after the first session
Title
Change from baseline to one month in CPM
Description
Conditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).
Time Frame
At baseline and at one month
Title
Change from baseline to three months in CPM
Description
Conditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).
Time Frame
At baseline and at three months
Title
Change from baseline to six months in CPM
Description
Conditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).
Time Frame
At baseline and at six months
Title
Change from baseline to immediately after the first session in TSP
Description
Temporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Time Frame
At baseline and immediately after the first session
Title
Change from baseline to one month in TSP
Description
Temporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in TSP
Description
Temporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in TSP
Description
Temporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Time Frame
At baseline and at six months
Title
Change from baseline to one month in TUG
Description
The Timed Up and Go (TUG) Test is a test especially indicated to measure mobility and assess the risk of falls in the elderly. The patient will begin sitting in a chair with his back supported and his arms on the armrests, when he hears the word "Let's go" he must get up and walk to a mark that will be on the ground 3 meters away and finally the person will turn around and walk again to sit on the chair. The time it takes from when you say "Let's go" until he sits down again will be timed (3 attempts and the results are averaged).
Time Frame
At baseline and at one month
Title
Change from baseline to three months in TUG
Description
The Timed Up and Go (TUG) Test is a test especially indicated to measure mobility and assess the risk of falls in the elderly. The patient will begin sitting in a chair with his back supported and his arms on the armrests, when he hears the word "Let's go" he must get up and walk to a mark that will be on the ground 3 meters away and finally the person will turn around and walk again to sit on the chair. The time it takes from when you say "Let's go" until he sits down again will be timed (3 attempts and the results are averaged).
Time Frame
At baseline and at three months
Title
Change from baseline to six months in TUG
Description
The Timed Up and Go (TUG) Test is a test especially indicated to measure mobility and assess the risk of falls in the elderly. The patient will begin sitting in a chair with his back supported and his arms on the armrests, when he hears the word "Let's go" he must get up and walk to a mark that will be on the ground 3 meters away and finally the person will turn around and walk again to sit on the chair. The time it takes from when you say "Let's go" until he sits down again will be timed (3 attempts and the results are averaged).
Time Frame
At baseline and at six months
Title
Change from baseline to one month in GCPS
Description
Pain severity will be assessed using the Spanish version of the Chronic Pain Grading Scale (GCPS). This scale is a self-reported instrument that consists of two subscales; the first assesses pain intensity, and the second assesses perceived disability. The scale is made up of a total of 8 items, 7 of which are 11 points in Likert format, and the other item assesses the perpetuation of pain, asking for the number of days of pain in the previous 6 months. The Spanish version of the GCPS has proven to be a valid and reliable instrument to assess the severity of chronic pain.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in GCPS
Description
Pain severity will be assessed using the Spanish version of the Chronic Pain Grading Scale (GCPS). This scale is a self-reported instrument that consists of two subscales; the first assesses pain intensity, and the second assesses perceived disability. The scale is made up of a total of 8 items, 7 of which are 11 points in Likert format, and the other item assesses the perpetuation of pain, asking for the number of days of pain in the previous 6 months. The Spanish version of the GCPS has proven to be a valid and reliable instrument to assess the severity of chronic pain.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in GCPS
Description
Pain severity will be assessed using the Spanish version of the Chronic Pain Grading Scale (GCPS). This scale is a self-reported instrument that consists of two subscales; the first assesses pain intensity, and the second assesses perceived disability. The scale is made up of a total of 8 items, 7 of which are 11 points in Likert format, and the other item assesses the perpetuation of pain, asking for the number of days of pain in the previous 6 months. The Spanish version of the GCPS has proven to be a valid and reliable instrument to assess the severity of chronic pain.
Time Frame
At baseline and at six months
Title
Baseline Mini-Mental Status
Description
MEC is the spanish version of the Mini-Mental Status Examination. It is the most widely used cognitive screening test to assess suspected symptoms compatible with cognitive impairment or dementia. Through a series of questions and requests, different cognitive functions are evaluated: temporal and spatial orientation, immediate memory, information storage and retrieval, concentration and working memory, oral language, reading and writing a sentence and visoconstruction by copying a simple drawing.
Time Frame
At baseline
Title
Change from baseline to one month in STAI
Description
The State-Trait Anxiety Inventory (STAI). This questionnaire comprises two subsections of 20 items each for the measurement of anxiety as a state and as a trait, with a 4-point Likert-type response (0: not at all; 3: very much). Scores range from 0 to 60 points, with higher scores indicating greater anxiety.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in STAI
Description
The State-Trait Anxiety Inventory (STAI). This questionnaire comprises two subsections of 20 items each for the measurement of anxiety as a state and as a trait, with a 4-point Likert-type response (0: not at all; 3: very much). Scores range from 0 to 60 points, with higher scores indicating greater anxiety.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in STAI
Description
The State-Trait Anxiety Inventory (STAI). This questionnaire comprises two subsections of 20 items each for the measurement of anxiety as a state and as a trait, with a 4-point Likert-type response (0: not at all; 3: very much). Scores range from 0 to 60 points, with higher scores indicating greater anxiety.
Time Frame
At baseline and at six months
Title
Change from baseline to one month in BDI-II
Description
Beck Depression Inventory-II (BDI-II) is a self-report measure of depression in a variety of settings and populations. It is the most widely used questionnaire worldwide to assess depression. The total score ranges from 0 to 63 points. A change of 5 points corresponds to a minimally important clinical difference.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in BDI-II
Description
Beck Depression Inventory-II (BDI-II) is a self-report measure of depression in a variety of settings and populations. It is the most widely used questionnaire worldwide to assess depression. The total score ranges from 0 to 63 points. A change of 5 points corresponds to a minimally important clinical difference.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in BDI-II
Description
Beck Depression Inventory-II (BDI-II) is a self-report measure of depression in a variety of settings and populations. It is the most widely used questionnaire worldwide to assess depression. The total score ranges from 0 to 63 points. A change of 5 points corresponds to a minimally important clinical difference.
Time Frame
At baseline and at six months
Title
Change from baseline to one month in PCS
Description
The Spanish version of the Pain Catastrophizing Scale (PCS) it has 13 items and each one is rated on a 5-point scale: 0 (not at all) to 4 (all the time). It comprises 3 dimensions: rumination, magnification, and despair. The theoretical range of the instrument is between 13 and 62, with low scores indicating low catastrophism and high values indicating high catastrophism.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in PCS
Description
The Spanish version of the Pain Catastrophizing Scale (PCS) it has 13 items and each one is rated on a 5-point scale: 0 (not at all) to 4 (all the time). It comprises 3 dimensions: rumination, magnification, and despair. The theoretical range of the instrument is between 13 and 62, with low scores indicating low catastrophism and high values indicating high catastrophism.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in PCS
Description
The Spanish version of the Pain Catastrophizing Scale (PCS) it has 13 items and each one is rated on a 5-point scale: 0 (not at all) to 4 (all the time). It comprises 3 dimensions: rumination, magnification, and despair. The theoretical range of the instrument is between 13 and 62, with low scores indicating low catastrophism and high values indicating high catastrophism.
Time Frame
At baseline and at six months
Title
Change from baseline to one month in TSK-11
Description
Tampa Scale for Kinesiophobia (TSK-11) is an 11-item scale that assesses the degree of fear of movement and (re)injury. Each item is scored from 1 to 4 according to the degree of agreement with the statement (1: do not agree at all; 4: strongly agree). The validated Spanish version of the 11-item scale has a total score of 11 to 44 items and has two subscales: activity avoidance and harm.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in TSK-11
Description
Tampa Scale for Kinesiophobia (TSK-11) is an 11-item scale that assesses the degree of fear of movement and (re)injury. Each item is scored from 1 to 4 according to the degree of agreement with the statement (1: do not agree at all; 4: strongly agree). The validated Spanish version of the 11-item scale has a total score of 11 to 44 items and has two subscales: activity avoidance and harm.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in TSK-11
Description
Tampa Scale for Kinesiophobia (TSK-11) is an 11-item scale that assesses the degree of fear of movement and (re)injury. Each item is scored from 1 to 4 according to the degree of agreement with the statement (1: do not agree at all; 4: strongly agree). The validated Spanish version of the 11-item scale has a total score of 11 to 44 items and has two subscales: activity avoidance and harm.
Time Frame
At baseline and at six months
Title
Change from baseline to immediately after the first intervention in catastrophism in vivo
Description
In vivo catastrophism. Questions will be asked regarding the types of thoughts and feelings of the patient while the painful stimulus was applied in the measurement of conditioned pain modulation. Using the a scale, you are asked to indicate the degree to which you had these thoughts and feelings during the pain test.
Time Frame
At baseline and immediately after the first intervention
Title
Change from baseline to one month in CRES-4
Description
Consumer Reports Effectiveness Scale (CRES-4) consisting of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. Its global score is intended to reflect treatment effectiveness as perceived by the patient.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in CRES-4
Description
Consumer Reports Effectiveness Scale (CRES-4) consisting of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. Its global score is intended to reflect treatment effectiveness as perceived by the patient.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in CRES-4
Description
Consumer Reports Effectiveness Scale (CRES-4) consisting of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. Its global score is intended to reflect treatment effectiveness as perceived by the patient.
Time Frame
At baseline and at six months
Title
Change from baseline to one month in GROC
Description
The Global Rating of Change Score (GRoC) is a frequently used outcome measure that has been used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores. The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in GROC
Description
The Global Rating of Change Score (GRoC) is a frequently used outcome measure that has been used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores. The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in GROC
Description
The Global Rating of Change Score (GRoC) is a frequently used outcome measure that has been used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores. The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter.
Time Frame
At baseline and at six months
Title
Baseline Demographic and Clinical Characteristics
Description
Demographic information including sex, age, weight, height, pain duration, the mean and worse pain intensities during the last week using the Visual Analogue Scale will be collected.
Time Frame
At baseline
Title
Change from baseline to one month in SPPB
Description
Short physical performance battery (SPPB). It makes it possible to classify the level of physical functioning of the elderly throughout the entire functional spectrum. It consists of carrying out three tests: balance (in three positions: feet together, semi-tandem and tandem), gait speed (4 meters) and getting up and sitting down on a chair five times.The total SPPB score and outcome assessment results from the sum of the three subtests, and ranges from 0 (worst) to 12; changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in SPPB
Description
Short physical performance battery (SPPB). It makes it possible to classify the level of physical functioning of the elderly throughout the entire functional spectrum. It consists of carrying out three tests: balance (in three positions: feet together, semi-tandem and tandem), gait speed (4 meters) and getting up and sitting down on a chair five times. The total SPPB score and outcome assessment results from the sum of the three subtests, and ranges from 0 (worst) to 12; changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in SPPB
Description
Short physical performance battery (SPPB). It makes it possible to classify the level of physical functioning of the elderly throughout the entire functional spectrum. It consists of carrying out three tests: balance (in three positions: feet together, semi-tandem and tandem), gait speed (4 meters) and getting up and sitting down on a chair five times. The total SPPB score and outcome assessment results from the sum of the three subtests, and ranges from 0 (worst) to 12; changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.
Time Frame
At baseline and at six months
Title
Change from baseline to one month in SF-12
Description
The SF-12 Health Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. Generic patient-reported outcome measures like the SF-12 assess general health and well-being, including the impact of any and all illnesses on a broad range of functional domains. The response options form Likert-type scales (where the number of options varies from three to six points, depending on the item), which evaluate intensity and/or frequency of people's health status. The score ranges from 0 to 100, where the higher the score, the better the health-related quality of life.
Time Frame
At baseline and at one month
Title
Change from baseline to three months in SF-12
Description
The SF-12 Health Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. Generic patient-reported outcome measures like the SF-12 assess general health and well-being, including the impact of any and all illnesses on a broad range of functional domains. The response options form Likert-type scales (where the number of options varies from three to six points, depending on the item), which evaluate intensity and/or frequency of people's health status. The score ranges from 0 to 100, where the higher the score, the better the health-related quality of life.
Time Frame
At baseline and at three months
Title
Change from baseline to six months in SF-12
Description
The SF-12 Health Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. Generic patient-reported outcome measures like the SF-12 assess general health and well-being, including the impact of any and all illnesses on a broad range of functional domains. The response options form Likert-type scales (where the number of options varies from three to six points, depending on the item), which evaluate intensity and/or frequency of people's health status. The score ranges from 0 to 100, where the higher the score, the better the health-related quality of life.
Time Frame
At baseline and at six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 45 years
Have activity related joint pain
Have morning stiffness ≤30 min
Knee pain of at least 6 months duration
OA diagnosis by physician
Current levels of moderate/vigorous physical activity (MVPA) below physical activity guideline recommendations (< 150 min/week of MVPA; assessed using the Active Australia Physical Activity Questionnaire)
Exclusion Criteria:
Health conditions that prevent safe participation in physical activity interventions as listed in the American College of Sports Medicine Guidelines (e.g., cardiac or lung disease).
Pain in other body areas that currently limits walking ability (e.g., back pain, foot pain, hip pain)
Neurological disorders affecting lower limb movement (e.g., multiple sclerosis or stroke).
Inflammatory arthritis (including rheumatoid arthritis)
Fibromyalgia
Previously operated knee is the most painful knee
Any condition impacting decision-making/memory (e.g., Alzheimer's, dementia)
Severe depression
Current moderate/vigorous physical activity levels above guideline recommendations (≥150 min/week; assessed using the Active Australia Physical Activity Questionnaire)
Currently undergoing regular, active intervention for the knee (e.g., seeing a physiotherapist)
Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo Rodríguez Lagos, MSc
Phone
914888949
Email
l.rodriguezla.2019@alumnos.urjc.es
First Name & Middle Initial & Last Name or Official Title & Degree
Josué Fernández Carnero, PhD
Phone
914888949
Email
josue.fernandez@urjc.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josué Fernández Carnero, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Madrid
ZIP/Postal Code
28047
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo Rodríguez Lagos, MSc
First Name & Middle Initial & Last Name & Degree
Josué Fernández Carnero, PhD
First Name & Middle Initial & Last Name & Degree
Sofía Laguarta Val, PhD
First Name & Middle Initial & Last Name & Degree
Daniel Martín Vera, PhD
First Name & Middle Initial & Last Name & Degree
Beatriz Serrano García, MSc
First Name & Middle Initial & Last Name & Degree
Alberto Arribas Romano, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34454458
Citation
Stanton TR, Braithwaite FA, Butler D, Moseley GL, Hill C, Milte R, Ratcliffe J, Maher C, Tomkins-Lane C, Pulling BW, MacIntyre E, Esterman A, Stanford T, Lee H, Fraysse F, Metcalf B, Mouatt B, Bennell K. The EPIPHA-KNEE trial: Explaining Pain to target unhelpful pain beliefs to Increase PHysical Activity in KNEE osteoarthritis - a protocol for a multicentre, randomised controlled trial with clinical- and cost-effectiveness analysis. BMC Musculoskelet Disord. 2021 Aug 28;22(1):738. doi: 10.1186/s12891-021-04561-6.
Results Reference
background
PubMed Identifier
19945354
Citation
Rakel B, Cooper N, Adams HJ, Messer BR, Frey Law LA, Dannen DR, Miller CA, Polehna AC, Ruggle RC, Vance CG, Walsh DM, Sluka KA. A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment. J Pain. 2010 Mar;11(3):230-8. doi: 10.1016/j.jpain.2009.07.007. Epub 2009 Nov 27.
Results Reference
background
PubMed Identifier
30013605
Citation
Mitchell UH, Stoneman P, Larson RE, Page GL. The Construction of Sham Dry Needles and Their Validity. Evid Based Complement Alternat Med. 2018 Jun 14;2018:9567061. doi: 10.1155/2018/9567061. eCollection 2018.
Results Reference
background
PubMed Identifier
25749012
Citation
Fingleton C, Smart K, Moloney N, Fullen BM, Doody C. Pain sensitization in people with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Jul;23(7):1043-56. doi: 10.1016/j.joca.2015.02.163. Epub 2015 Mar 5.
Results Reference
background
PubMed Identifier
27818699
Citation
Shim JW, Jung JY, Kim SS. Effects of Electroacupuncture for Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2016;2016:3485875. doi: 10.1155/2016/3485875. Epub 2016 Oct 13.
Results Reference
background
PubMed Identifier
29864043
Citation
Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.
Results Reference
background
PubMed Identifier
17907210
Citation
Pisters MF, Veenhof C, van Meeteren NL, Ostelo RW, de Bakker DH, Schellevis FG, Dekker J. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review. Arthritis Rheum. 2007 Oct 15;57(7):1245-53. doi: 10.1002/art.23009.
Results Reference
background
PubMed Identifier
26051220
Citation
Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5.
Results Reference
background
PubMed Identifier
24425500
Citation
Kroon FP, van der Burg LR, Buchbinder R, Osborne RH, Johnston RV, Pitt V. Self-management education programmes for osteoarthritis. Cochrane Database Syst Rev. 2014 Jan 15;(1):CD008963. doi: 10.1002/14651858.CD008963.pub2.
Results Reference
background
PubMed Identifier
33490835
Citation
Stanton TR, Karran EL, Butler DS, Hull MJ, Schwetlik SN, Braithwaite FA, Jones HG, Moseley GL, Hill CL, Tomkins-Lane C, Maher C, Bennell K. A pain science education and walking program to increase physical activity in people with symptomatic knee osteoarthritis: a feasibility study. Pain Rep. 2020 Sep 24;5(5):e830. doi: 10.1097/PR9.0000000000000830. eCollection 2020 Sep-Oct.
Results Reference
background
Learn more about this trial
Percutaneous Electrical Stimulation, Education and Exercise Program in Patients With Knee Osteoarthritis
We'll reach out to this number within 24 hrs