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

January 11, 2020 updated by: Riphah International University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 40100
        • Pakistan Railway Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EMG Biofeedback assisted Quadriceps exercises.
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.
Device: Electromyographic Biofeedback
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
ACTIVE_COMPARATOR: Quadriceps exercises without EMG Biofeedback
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.
Other: Quadriceps Isometric exercises
In supine lying or sitting, Patient is asked to press down knee while contracting Quadriceps muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post 6 Weeks
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.
Post 6th week
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
Post 6th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Post 6 weeks
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.
Post 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ACTUAL)

January 3, 2020

Study Completion (ACTUAL)

January 8, 2020

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (ACTUAL)

December 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 11, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RiphahIU Huma Khan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Electromyographic Biofeedback

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe