Back to resultsRepetitive Transcranial Magnetic Stimulation Associated With Manual Therapy in Knee Ostearthritis Pain
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
TMS
Manual therapy (MT)
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee ostearthritis, transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, chronic pain, musculoskeletal manipulations
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of knee OA;
- Absence of severe cognitive deficiency verified by the Mini Mental State Examination;
- Meet the American College of Rheumatology criteria for idiopathic knee osteoarthritis.
Exclusion Criteria:
- Individuals diagnosed with osteoporosis, fibromyalgia or other neurological disease;
- Had an opioid or corticosteroid injection in the last 30 days;
- Modified chronic pain medication in the last month before participating in the study;
- History of knee surgery in the last six months;
- Obese;
- Contraindications to the use of non-invasive brain stimulation, such as: metal implant on face or skull, history of seizure, cochlear implant.
Sites / Locations
- Applied Neuroscience Laboratory, Universidade Federal de PernambucoRecruiting
- Kinesiotherapy and manual therapeutic resources laboratoryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
MT after rTMS group
rTMS after MT group
Control group
Arm Description
High frequency TMS will be applied with an eight-shaped coil angled at zero degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1). Twenty four stimulus trains will be provided at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 1200 pulses for approximately 12 minutes, with 90% of resting motor threshold (RMT). After TMS, patients will be submitted to 45 minutes of manual therapy protocol.
Patients will be submitted to 45 minutes of manual therapy protocol. After that, high frequency TMS will be applied with an eight-shaped coil angled at zero degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1). Twenty four stimulus trains will be provided at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 1200 pulses for approximately 12 minutes, with 90% of resting motor threshold (RMT).
In this group, the order of interventions will be randomized. Therefore, the volunteer can start with manual therapy or sham TMS. In manual therapy, patients will be submitted to 45 minutes of a protocol. In addition, with regard to sham TMS, the same parameters will be used, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation.
Outcomes
Primary Outcome Measures
Pain
Pain will be evaluated by pressure algometry before and after the interventions. It's a evaluation technique which aims to quantify through physical stimulation (pressure in the nociceptors) the capacity of pain perception and toleration. It will be used with the patient lying in supine and will have the purpose of measure the pressure pain threshold (PPT) in eight points around patellar region. Besides that, two control points will be adopted, one in anterior tibial muscle (five centimeters distal of anterior tibial tuberosity) and another in the extensor carpi radialis longus muscle (five centimeters distal to lateral humerus epicondyle). After marking, the algometer will be setted up 90° in contact with the skin and will be applied a 0,3 kgf/cm²/s pressure until the patient report pain by pressing a pen (Model/Brand: Algomed/Medoc). The measure will be done twice in the demarcated points with a two minutes interval between them. Will be considered a mean of the obtained values.
Pain Rating Scale (NPRS)
Is it used to quantify pain level, where 0 means no pain and 10 means worst pain possible. NPRS is recommended as the main endpoint in chronic pain studies and it has been established that a decrease of at least 2 points or 30% represents a minimal clinically important difference. The MDCI consists of the smaller variation in a clinical outcome perceived by the patient and that results in a relevant change in his state of health.
Secondary Outcome Measures
Cortical excitability
The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould).
Full Information
NCT ID
NCT03076294
First Posted
March 6, 2017
Last Updated
March 6, 2017
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT03076294
Brief Title
Repetitive Transcranial Magnetic Stimulation Associated With Manual Therapy in Knee Ostearthritis Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, the investigators wondered whether the association between high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and manual therapy (peripheral and central approach) is more effective in reducing pain levels and modulation of cortical activity of chronic knee ostearthritis pain subjects than manual therapy alone (usual peripheral approach). For this purpose, patients included will be submitted to one session with active or sham hf-rTMS followed by a protocol of manual therapy. Besides that another active group will have the sequence of interventions exchanged (manual therapy followed by hf-rTMS) in order to investigate whether this may influence in the final outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee ostearthritis, transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, chronic pain, musculoskeletal manipulations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MT after rTMS group
Arm Type
Experimental
Arm Description
High frequency TMS will be applied with an eight-shaped coil angled at zero degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1). Twenty four stimulus trains will be provided at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 1200 pulses for approximately 12 minutes, with 90% of resting motor threshold (RMT). After TMS, patients will be submitted to 45 minutes of manual therapy protocol.
Arm Title
rTMS after MT group
Arm Type
Experimental
Arm Description
Patients will be submitted to 45 minutes of manual therapy protocol. After that, high frequency TMS will be applied with an eight-shaped coil angled at zero degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1). Twenty four stimulus trains will be provided at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 1200 pulses for approximately 12 minutes, with 90% of resting motor threshold (RMT).
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
In this group, the order of interventions will be randomized. Therefore, the volunteer can start with manual therapy or sham TMS. In manual therapy, patients will be submitted to 45 minutes of a protocol. In addition, with regard to sham TMS, the same parameters will be used, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation.
Intervention Type
Device
Intervention Name(s)
TMS
Other Intervention Name(s)
non invasive brain stimulation, high frequency TMS
Intervention Description
Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause minimal discomfort with a mild headache sensation, which usually disappears after a few seconds. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing pain control. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.
Intervention Type
Other
Intervention Name(s)
Manual therapy (MT)
Other Intervention Name(s)
Musculoskeletal manipulation
Intervention Description
This intervention uses manual contact for diagnosis and treatment, its practitioners use an enormous amount of manual techniques to preserve the homeostasis through the recovery of dysfunctions, which may cause limitations in the physiological movements, in the accessory movements of the joints (WHO , 2010).
Primary Outcome Measure Information:
Title
Pain
Description
Pain will be evaluated by pressure algometry before and after the interventions. It's a evaluation technique which aims to quantify through physical stimulation (pressure in the nociceptors) the capacity of pain perception and toleration. It will be used with the patient lying in supine and will have the purpose of measure the pressure pain threshold (PPT) in eight points around patellar region. Besides that, two control points will be adopted, one in anterior tibial muscle (five centimeters distal of anterior tibial tuberosity) and another in the extensor carpi radialis longus muscle (five centimeters distal to lateral humerus epicondyle). After marking, the algometer will be setted up 90° in contact with the skin and will be applied a 0,3 kgf/cm²/s pressure until the patient report pain by pressing a pen (Model/Brand: Algomed/Medoc). The measure will be done twice in the demarcated points with a two minutes interval between them. Will be considered a mean of the obtained values.
Time Frame
Until one day (before and after the interventions)
Title
Pain Rating Scale (NPRS)
Description
Is it used to quantify pain level, where 0 means no pain and 10 means worst pain possible. NPRS is recommended as the main endpoint in chronic pain studies and it has been established that a decrease of at least 2 points or 30% represents a minimal clinically important difference. The MDCI consists of the smaller variation in a clinical outcome perceived by the patient and that results in a relevant change in his state of health.
Time Frame
Until 30 days (before, after the interventions and until the last day with the same value of the first evaluation)
Secondary Outcome Measure Information:
Title
Cortical excitability
Description
The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould).
Time Frame
One day (before and after the interventions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of knee OA;
Absence of severe cognitive deficiency verified by the Mini Mental State Examination;
Meet the American College of Rheumatology criteria for idiopathic knee osteoarthritis.
Exclusion Criteria:
Individuals diagnosed with osteoporosis, fibromyalgia or other neurological disease;
Had an opioid or corticosteroid injection in the last 30 days;
Modified chronic pain medication in the last month before participating in the study;
History of knee surgery in the last six months;
Obese;
Contraindications to the use of non-invasive brain stimulation, such as: metal implant on face or skull, history of seizure, cochlear implant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kátia Monte-Silva, PhD
Phone
+55 81 988631322
Email
monte.silvakk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mannaly Mendonça, PT
Phone
+55 81 995554000
Email
mannaly@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kátia Monte-Silva, PhD
Organizational Affiliation
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Official's Role
Study Director
Facility Information:
Facility Name
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
City
Recife
State/Province
PE
ZIP/Postal Code
50670-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Déborah Marques, MSc
Phone
+55 81 997479444
Email
deby.marques@gmail.com
First Name & Middle Initial & Last Name & Degree
Sérgio Rocha, MSc
Phone
+55 81 997708502
Email
srocha3105@gmail.com
First Name & Middle Initial & Last Name & Degree
Mannaly Mendonça, PT
First Name & Middle Initial & Last Name & Degree
Déborah Marques, MSc
First Name & Middle Initial & Last Name & Degree
Sérgio Rocha, MSc
Facility Name
Kinesiotherapy and manual therapeutic resources laboratory
City
Recife
State/Province
PE
ZIP/Postal Code
50670-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria das Graças Araújo, PhD
Phone
+55 81 999729856
Email
mgrodriguesaraujo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Maria das Graças Araújo, PhD
12. IPD Sharing Statement
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation Associated With Manual Therapy in Knee Ostearthritis Pain
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