NCT04194853

Brief Summary

This study intends to determine the Effects of Electromyographic biofeedback on performance of vastus medialis oblique muscle in knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

November 20, 2019

Last Update Submit

January 11, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    Post 6th week

Secondary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Post 6 weeks

Study Arms (2)

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.

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.

Other: Quadriceps Isometric exercises

Interventions

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

EMG Biofeedback assisted Quadriceps exercises.

In supine lying or sitting, Patient is asked to press down knee while contracting Quadriceps muscles.

Quadriceps exercises without EMG Biofeedback

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Railway hospital

Rawalpindi, Punjab Province, 40100, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 30519081BACKGROUND
  • 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.

    PMID: 25642061BACKGROUND
  • 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.

    PMID: 27149595BACKGROUND
  • 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.

    PMID: 31091492BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Huma Riaz, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

December 11, 2019

Study Start

August 1, 2019

Primary Completion

January 3, 2020

Study Completion

January 8, 2020

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations