Knee OsteoarthritisNCT04194853
Electromyographic Biofeedback on Performance of Vastus Medialis Oblique Muscle in Knee Osteoarthritis
A study testing Electromyographic Biofeedback and Quadriceps Isometric exercises in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study intends to determine the Effects of Electromyographic biofeedback on performance of vastus medialis oblique muscle in knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Electromyographic Biofeedback and Quadriceps Isometric exercises
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2019to 8 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age : In between 45 - 65years
- Both Genders
- Subjects with a definite diagnosis of knee OA according to the guidelines of the American College of Rheumatology with at least 6 months of knee pain.
- Grade 1 or 2 joint cartilage degradation based on the Kellgren-Lawrence classification
- Body mass index (BMI) of <35 kg/m2
Who cannot join
- Subjects who had undergone physical therapy or intraarticular injection in the past 3 months
- Patients who had taken oral corticosteroids in the past 4 weeks
- Patients with a history of surgical interventions on their knees
- Subjects with a history of radiculopathy, or those with a history of systemic diseases, such as rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Electromyographic Biofeedback on Performance of Vastus Medialis Oblique Muscle in Knee Osteoarthritis
This study intends to determine the Effects of Electromyographic biofeedback on performance of vastus medialis oblique muscle in knee osteoarthritis.
Read the detailed description
This is a single blinded randomized controlled trial, will be conducted at Railway General Hospital.Rawalpindi.
(EMG) biofeedback as an adjunct therapy to standard exercise regime for increasing muscle strength ,this study is planned to determine the effects of electromyographic biofeedback on performance and thickness of vastus medialis oblique muscle, knee pain and on lower extremity function in patients with Knee Osteoarthritis. The sample size was calculated to be n=34 through Open Epi tool version 3, with 95 % confidence interval (CI), and power 80%.
After the completion of therapeutic protocols, the participants will be assessed with the help of Numeric Pain Rating Scale (NPRS), WOMAC, Lequesne questionnaire , 1 Repetition maximum( RM) and with MSK ultrasound
- Conditions
- Knee Osteoarthritis
- Being tested
- Electromyographic Biofeedback, Quadriceps Isometric exercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyographic BiofeedbackDevice
Surface EMG biofeedback is an adjunct therapy to standard exercise regime for increasing muscle strength .Electromyographic (EMG) biofeedback is a specific form of biofeedback. The biofeedback device records muscle activity through the application of electrodes superficially or subcutaneously when targeting specific muscles
Quadriceps Isometric exercisesOther
In supine lying or sitting, Patient is asked to press down knee while contracting Quadriceps muscles.
| Study group | Role | What they receive |
|---|---|---|
| EMG Biofeedback assisted Quadriceps exercises. | Experimental | Hot Pack will be applied before session for general relaxation for 10 minutes. Knee isometric exercises will be performed via an EMG Biofeedback device; patients in the EMG BF group will receive visual and auditory feedback.Knee isometrics will be performed with 5 seconds hold. Then, the muscle will be relaxed for 10 seconds and the cycle repeated for a total of 15 minutes. (20 reps, 3 sets) Session will be performed thrice a week for six weeks. Receives: Device: Electromyographic Biofeedback |
| Quadriceps exercises without EMG Biofeedback | Active comparator | Hot Pack will be applied before session for general relaxation 10 minutes. In the control group, the active electrode will not be connected, so subjects will not receive any feedback from the device. Knee isometrics perform with 5 seconds hold. Then, the muscle will be relaxed for 10 seconds and the cycle repeated for a total of 15 minutes. (20 reps, 3 sets)Session will be performed thrice a week for six weeks. Receives: Other: Quadriceps Isometric exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Changes from the baseline, Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Measured: Post 6 Weeks
1 Repetition Maximum
Changes from the baseline, 1 RM Is used to assess maximum muscle strength. Patient is asked to extend knee against maximum resistance once.
Measured: Post 6th week
Vastus medialis Oblique(VMO) Thickness
Changes from the Baseline, Musculoskeletal ultrasound will be used to measure maximum thickness of VMO muscle. Assessment will be done by a Consultant radiologist using a 7-12 MHz probe
Measured: Post 6th week
Secondary outcomes (1)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Changes from the baseline, WOMAC is used to assess the functional status. The questionnaire includes five questions about pain severity (0-20), two items on joint stiffness (0-8), and 17 questions on functional limitations of the patient (0-68). Each item is scored on a scale of 0-4, and the greater the score, the worse the pain and function. The total score of the subjects from this index was reported from a total of 96.
Measured: Post 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Aug 2019
- Primary completion3 Jan 2020
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two treatment groups of participants, Experimental group will receive Isometric exercises with EMGBF( Electromyographic Biofeedback ) and control group receive exercises without EMGBF.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194853
- Sponsor's protocol ID
- RiphahIU Huma Khan
- Status last verified
- Jan 2020
- First submitted
- 20 Nov 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raeissadat SA, Rayegani SM, Sedighipour L, Bossaghzade Z, Abdollahzadeh MH, Nikray R, Mollayi F. The efficacy of electromyographic biofeedback on pain, function, and maximal thickness of vastus medialis oblique muscle in patients with knee osteoarthritis: a randomized clinical trial. J Pain Res. 2018 Nov 8;11:2781-2789. doi: 10.2147/JPR.S169613. eCollection 2018.
PubMed 30519081Choi YL, Kim BK, Hwang YP, Moon OK, Choi WS. Effects of isometric exercise using biofeedback on maximum voluntary isometric contraction, pain, and muscle thickness in patients with knee osteoarthritis. J Phys Ther Sci. 2015 Jan;27(1):149-53. doi: 10.1589/jpts.27.149. Epub 2015 Jan 9.
PubMed 25642061Eid MA, Aly SM, El-Shamy SM. Effect of Electromyographic Biofeedback Training on Pain, Quadriceps Muscle Strength, and Functional Ability in Juvenile Rheumatoid Arthritis. Am J Phys Med Rehabil. 2016 Dec;95(12):921-930. doi: 10.1097/PHM.0000000000000524.
PubMed 27149595Florencio LL, Martins J, da Silva MRB, da Silva JR, Bellizzi GL, Bevilaqua-Grossi D. Knee and hip strength measurements obtained by a hand-held dynamometer stabilized by a belt and an examiner demonstrate parallel reliability but not agreement. Phys Ther Sport. 2019 Jul;38:115-122. doi: 10.1016/j.ptsp.2019.04.011. Epub 2019 Apr 25.
PubMed 31091492
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electromyographic Biofeedback on Performance of Vastus Medialis Oblique Muscle in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04194853
- Acronym / sponsor ID
- RiphahIU Huma Khan
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to determine the Effects of Electromyographic biofeedback on performance of vastus medialis oblique muscle in knee osteoarthritis.
Detailed description
This is a single blinded randomized controlled trial, will be conducted at Railway General Hospital.Rawalpindi.
(EMG) biofeedback as an adjunct therapy to standard exercise regime for increasing muscle strength ,this study is planned to determine the effects of electromyographic biofeedback on performance and thickness of vastus medialis oblique muscle, knee pain and on lower extremity function in patients with Knee Osteoarthritis. The sample size was calculated to be n=34 through Open Epi tool version 3, with 95 % confidence interval (CI), and power 80%.
After the completion of therapeutic protocols, the participants will be assessed with the help of Numeric Pain Rating Scale (NPRS), WOMAC, Lequesne questionnaire , 1 Repetition maximum( RM) and with MSK ultrasound
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There will be two treatment groups of participants, Experimental group will receive Isometric exercises with EMGBF( Electromyographic Biofeedback ) and control group receive exercises without EMGBF.
| Arm | Type | Receives |
|---|---|---|
| EMG Biofeedback assisted Quadriceps exercises. | Experimental | Device: Electromyographic BiofeedbackHot Pack will be applied before session for general relaxation for 10 minutes. Knee isometric exercises will be performed via an EMG Biofeedback device; patients in the EMG BF group will receive visual and auditory feedback.Knee isometrics will be performed with 5 seconds hold. Then, the muscle will be relaxed for 10 seconds and the cycle repeated for a total of 15 minutes. (20 reps, 3 sets) Session will be performed thrice a week for six weeks. |
| Quadriceps exercises without EMG Biofeedback | Active comparator | Other: Quadriceps Isometric exercisesHot Pack will be applied before session for general relaxation 10 minutes. In the control group, the active electrode will not be connected, so subjects will not receive any feedback from the device. Knee isometrics perform with 5 seconds hold. Then, the muscle will be relaxed for 10 seconds and the cycle repeated for a total of 15 minutes. (20 reps, 3 sets)Session will be performed thrice a week for six weeks. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age : In between 45 - 65years
- Both Genders
- Subjects with a definite diagnosis of knee OA according to the guidelines of the American College of Rheumatology with at least 6 months of knee pain.
- Grade 1 or 2 joint cartilage degradation based on the Kellgren-Lawrence classification
- Body mass index (BMI) of <35 kg/m2
Key exclusion criteria (4 listed)
- Subjects who had undergone physical therapy or intraarticular injection in the past 3 months
- Patients who had taken oral corticosteroids in the past 4 weeks
- Patients with a history of surgical interventions on their knees
- Subjects with a history of radiculopathy, or those with a history of systemic diseases, such as rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyographic BiofeedbackSurface EMG biofeedback is an adjunct therapy to standard exercise regime for increasing muscle strength .Electromyographic (EMG) biofeedback is a specific form of biofeedback. The biofeedback device records muscle activity through the application of electrodes superficially or subcutaneously when targeting specific muscles | Device | EMG Biofeedback assisted Quadriceps exercises. |
| Quadriceps Isometric exercisesIn supine lying or sitting, Patient is asked to press down knee while contracting Quadriceps muscles. | Other | Quadriceps exercises without EMG Biofeedback |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: Post 6 Weeks
Changes from the baseline, Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
1 Repetition Maximum
Time frame: Post 6th week
Changes from the baseline, 1 RM Is used to assess maximum muscle strength. Patient is asked to extend knee against maximum resistance once.
Vastus medialis Oblique(VMO) Thickness
Time frame: Post 6th week
Changes from the Baseline, Musculoskeletal ultrasound will be used to measure maximum thickness of VMO muscle. Assessment will be done by a Consultant radiologist using a 7-12 MHz probe
1 secondary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Post 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Background: PubMed 30519081Raeissadat SA, Rayegani SM, Sedighipour L, Bossaghzade Z, Abdollahzadeh MH, Nikray R, Mollayi F. The efficacy of electromyographic biofeedback on pain, function, and maximal thickness of vastus medialis oblique muscle in patients with knee osteoarthritis: a randomized clinical trial. J Pain Res. 2018 Nov 8;11:2781-2789. doi: 10.2147/JPR.S169613. eCollection 2018.
- Background: PubMed 25642061Choi YL, Kim BK, Hwang YP, Moon OK, Choi WS. Effects of isometric exercise using biofeedback on maximum voluntary isometric contraction, pain, and muscle thickness in patients with knee osteoarthritis. J Phys Ther Sci. 2015 Jan;27(1):149-53. doi: 10.1589/jpts.27.149. Epub 2015 Jan 9.
- Background: PubMed 27149595Eid MA, Aly SM, El-Shamy SM. Effect of Electromyographic Biofeedback Training on Pain, Quadriceps Muscle Strength, and Functional Ability in Juvenile Rheumatoid Arthritis. Am J Phys Med Rehabil. 2016 Dec;95(12):921-930. doi: 10.1097/PHM.0000000000000524.
- Background: PubMed 31091492Florencio LL, Martins J, da Silva MRB, da Silva JR, Bellizzi GL, Bevilaqua-Grossi D. Knee and hip strength measurements obtained by a hand-held dynamometer stabilized by a belt and an examiner demonstrate parallel reliability but not agreement. Phys Ther Sport. 2019 Jul;38:115-122. doi: 10.1016/j.ptsp.2019.04.011. Epub 2019 Apr 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Riaz, PHD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyographic Biofeedback and Quadriceps Isometric exercises in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Post 6 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194853, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.