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Electromyographic Biofeedback on Performance of Vastus Medialis Oblique Muscle in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Electromyographic Biofeedback
Quadriceps Isometric exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Pakistan Railway hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EMG Biofeedback assisted Quadriceps exercises.

Quadriceps exercises without EMG Biofeedback

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

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.

Full Information

First Posted
November 20, 2019
Last Updated
January 11, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04194853
Brief Title
Electromyographic Biofeedback on Performance of Vastus Medialis Oblique Muscle in Knee Osteoarthritis
Official Title
Effects of Electromyographic Biofeedback on Performance of Vastus Medialis Oblique Muscle in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 3, 2020 (Actual)
Study Completion Date
January 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking 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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMG Biofeedback assisted Quadriceps exercises.
Arm Type
Experimental
Arm Description
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.
Arm Title
Quadriceps exercises without EMG Biofeedback
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Electromyographic Biofeedback
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Quadriceps Isometric exercises
Intervention Description
In supine lying or sitting, Patient is asked to press down knee while contracting Quadriceps muscles.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
Post 6 Weeks
Title
1 Repetition Maximum
Description
Changes from the baseline, 1 RM Is used to assess maximum muscle strength. Patient is asked to extend knee against maximum resistance once.
Time Frame
Post 6th week
Title
Vastus medialis Oblique(VMO) Thickness
Description
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
Time Frame
Post 6th week
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Post 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
40100
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30519081
Citation
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.
Results Reference
background
PubMed Identifier
25642061
Citation
Choi 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.
Results Reference
background
PubMed Identifier
27149595
Citation
Eid 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.
Results Reference
background
PubMed Identifier
31091492
Citation
Florencio 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.
Results Reference
background

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Electromyographic Biofeedback on Performance of Vastus Medialis Oblique Muscle in Knee Osteoarthritis

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