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Completed

NCT Number: NCT04194853

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Railway hospital

Rawalpindi, Punjab Province, 40100, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electromyographic Biofeedback

Device

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 exercises

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2019
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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