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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194853
• Other study ID #: RiphahIU Huma Khan
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 8, 2020

Study information

• Verified date: January 2020
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 8, 2020
• Est. primary completion date: January 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Other:
• Quadriceps Isometric exercises
In supine lying or sitting, Patient is asked to press down knee while contracting Quadriceps muscles.

Locations

Country	Name	City	State
Pakistan	Pakistan Railway hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Post 6 weeks