Back to resultsImprovement in Pain and Function Following a Physiotherapy Program in Older Adults With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic exercise
Dry needling
Sham dry needling
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Stiffness, Pain, Disfunction
Eligibility Criteria
Inclusion Criteria:
- Participants aged 62 years and older.
- Unilateral or bilateral disfunction and/or knee pain.
- Primary knee ostearthritis fulfilling the American College of Rheumatology criteria for clinical and radiographic diagnostic.
- At least 1 pain point elicited by palpation ipsilateral to the painful knee situated in a taut band of a skeletal muscle of the lower limbs, which usually have referred pain.
Exclusion Criteria:
- Prior diagnoses or prescriptions in the medical record for myopathy or lumbo-sacral neuropathy.
- Previous knee or hip joint replacement surgery of the affected joint.
- Any other surgical procedure of the lower limbs in the previous 6 months.
- Rheumatoid arthritis.
- Initiation of opioid analgesia or cortico-steroid or analgesic injection intervention for hip or knee pain within the previous 30 days.
- Alcohol or drugs consumption.
- Uncontrolled hypertension or moderate to high risk for cardiac complications during exercise.
- Conservative or invasive physical therapy (previous 6 months or during follow-up).
- Taking antiaggregant or anticoagulant medications.
- Physical impairments unrelated to the hip or knee preventing safe participation in exercise, walking or stationary cycling, such as: vision problems that affect mobility, body weight greater than 155 kg, neurogenic disorder, primary or significantly limiting back pain, advanced osteoporosis, or inability to walk 10 metres without an assistive device.
- Inability to comprehend and complete study assessments or comply with study instructions.
- Stated inability to attend or complete the proposed course of intervention and follow-up schedule.
- Fibromyalgia syndrome or other altered affective/cognitive modulation processes of pain perception. .
Sites / Locations
- Universidad Rey Juan Carlos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise and dry needling
Exercise and sham dry needling
Arm Description
24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min). 6 dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using Hong's fast-in and fast-out technique with multiple rapid needle insertion.
24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min). 6 sham dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using a park sham device consists of a base with a hole in the centre and sticky tape on the bottom. From the top of the base extends a double tube, continuing the central hole in the base.
Outcomes
Primary Outcome Measures
Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment.
The disease-specific questionnaire WOMAC is the most widely used instrument created and validated to evaluate both the symptomatology and function on osteoarthritis of the hip or knee.
Secondary Outcome Measures
Numeric Pain Rating Scale (NPRS)
Pain intensity will be assessed using a NPRS of 11 points (from 0, no pain, to 10, maximum pain). The patient determined their subjective pain intensity of the painful knee by pointing with 1 of their fingers to mark the level of pain on the scale. .
Barthel Index
The Barthel Index is considered to be the best of the activities of daily living measurement scales. The modified scoring of the Barthel Index by Shah achieved greater sensitivity and improved reliability than the original version, without causing additional difficulty or affecting the implementation time.
The Timed Up & Go Test
The patient is asked to perform the rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return, return and sit down again. The score given is the time taken in seconds to complete the test.
Mini-Mental State Examination (MMSE)
It's a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment and to screen for dementia.
EuroQol-5
It provides a simple descriptive profile and a single index value for health status through rating of 5 items.
Full Information
NCT ID
NCT02698072
First Posted
January 4, 2016
Last Updated
December 11, 2017
Sponsor
Universidad Rey Juan Carlos
Collaborators
Ilustre Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02698072
Brief Title
Improvement in Pain and Function Following a Physiotherapy Program in Older Adults With Knee Osteoarthritis
Official Title
Improvement in Pain and Function Following a Therapeutic Exercise Program and Dry Needling in Older Adults With Knee Osteoarthritis: A Randomized Double-blind Multicenter Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 15, 2016 (Actual)
Primary Completion Date
June 16, 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
Collaborators
Ilustre Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the combination of a therapeutic exercise program and dry needling in the treatment of knee osteoarthritis in older adults. Half of participants will receive therapeutic exercise program and dry needling in combination, while the other half will receive the same therapeutic exercise program and sham dry needling.
Detailed Description
Therapeutic exercise and dry needling each relieve pain and improve function, but they are different treatment tools.
Therapeutic exercise takes a multitude of forms and results in numerous systemic and local effects, some of which have been investigate among people with knee osteoarthritis. Therapeutic exercise covers a range of targeted physical activities that directly aim to improve muscle strength, neuromotor control, joint range of motion and aerobic fitness. One of the main aims of this therapeutic approach is to improve muscle strength, given that weakness is common in knee osteoarthritis. Enhanced strength of the lower limb may lessen internal knee forces, reduce pain and improve physical function.
Primary knee osteoarthritis provokes pain and disfunction is thought mediated by joint damage and changes in joint homeostasis. Recently, investigations focused in impaired neuromuscular system as a contribution to the above mentioned symptoms in the knee osteoarthritis syndrome explore the use of dry needling. Dry needling is a therapeutic approach for decreasing pain and improve function with high recommended evidence (grade A) effectiveness for upper-quarter myofascial pain, but poorly understood in knee osteoarthritis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Stiffness, Pain, Disfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise and dry needling
Arm Type
Experimental
Arm Description
24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min).
6 dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using Hong's fast-in and fast-out technique with multiple rapid needle insertion.
Arm Title
Exercise and sham dry needling
Arm Type
Active Comparator
Arm Description
24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min).
6 sham dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using a park sham device consists of a base with a hole in the centre and sticky tape on the bottom. From the top of the base extends a double tube, continuing the central hole in the base.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Intervention Description
20-25 minutes aerobic exercise, 20-25 minutes strength exercise and 10-15 minutes stretch exercise.
Intervention Type
Device
Intervention Name(s)
Dry needling
Intervention Description
Dry needling needle AGUPUNT®
Intervention Type
Device
Intervention Name(s)
Sham dry needling
Intervention Description
Sham dry needling DONGBANG-ACUPRIME®
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment.
Description
The disease-specific questionnaire WOMAC is the most widely used instrument created and validated to evaluate both the symptomatology and function on osteoarthritis of the hip or knee.
Time Frame
Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
Pain intensity will be assessed using a NPRS of 11 points (from 0, no pain, to 10, maximum pain). The patient determined their subjective pain intensity of the painful knee by pointing with 1 of their fingers to mark the level of pain on the scale. .
Time Frame
Base line, through study completion (3 months); ; and 3, 6 and 12 months follow-up
Title
Barthel Index
Description
The Barthel Index is considered to be the best of the activities of daily living measurement scales. The modified scoring of the Barthel Index by Shah achieved greater sensitivity and improved reliability than the original version, without causing additional difficulty or affecting the implementation time.
Time Frame
Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
Title
The Timed Up & Go Test
Description
The patient is asked to perform the rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return, return and sit down again. The score given is the time taken in seconds to complete the test.
Time Frame
Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
Title
Mini-Mental State Examination (MMSE)
Description
It's a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment and to screen for dementia.
Time Frame
Base line and 12 months follow-up
Title
EuroQol-5
Description
It provides a simple descriptive profile and a single index value for health status through rating of 5 items.
Time Frame
Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
Other Pre-specified Outcome Measures:
Title
Total number of falls change assessment.
Description
Total number of falls at 1 year follow-up, and to compare with number of falls at one year before the participation on the study.
Time Frame
At Baseline and 1 year follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
62 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants aged 62 years and older.
Unilateral or bilateral disfunction and/or knee pain.
Primary knee ostearthritis fulfilling the American College of Rheumatology criteria for clinical and radiographic diagnostic.
At least 1 pain point elicited by palpation ipsilateral to the painful knee situated in a taut band of a skeletal muscle of the lower limbs, which usually have referred pain.
Exclusion Criteria:
Prior diagnoses or prescriptions in the medical record for myopathy or lumbo-sacral neuropathy.
Previous knee or hip joint replacement surgery of the affected joint.
Any other surgical procedure of the lower limbs in the previous 6 months.
Rheumatoid arthritis.
Initiation of opioid analgesia or cortico-steroid or analgesic injection intervention for hip or knee pain within the previous 30 days.
Alcohol or drugs consumption.
Uncontrolled hypertension or moderate to high risk for cardiac complications during exercise.
Conservative or invasive physical therapy (previous 6 months or during follow-up).
Taking antiaggregant or anticoagulant medications.
Physical impairments unrelated to the hip or knee preventing safe participation in exercise, walking or stationary cycling, such as: vision problems that affect mobility, body weight greater than 155 kg, neurogenic disorder, primary or significantly limiting back pain, advanced osteoporosis, or inability to walk 10 metres without an assistive device.
Inability to comprehend and complete study assessments or comply with study instructions.
Stated inability to attend or complete the proposed course of intervention and follow-up schedule.
Fibromyalgia syndrome or other altered affective/cognitive modulation processes of pain perception. .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleuterio Atanasio Sánchez Romero, PT, MSc
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30889250
Citation
Sanchez Romero EA, Fernandez-Carnero J, Calvo-Lobo C, Ochoa Saez V, Burgos Caballero V, Pecos-Martin D. Is a Combination of Exercise and Dry Needling Effective for Knee OA? Pain Med. 2020 Feb 1;21(2):349-363. doi: 10.1093/pm/pnz036.
Results Reference
derived
Links:
URL
http://www.urjc.es
Description
website of the University Rey Juan Carlos
Learn more about this trial
Improvement in Pain and Function Following a Physiotherapy Program in Older Adults With Knee Osteoarthritis
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