Effects of Muscle Energy Technique in Knee Osteoarthritis Patients

Effects of Muscle Energy Technique Along Conventional Physical Therapy After Mesenchymal Stem Cell Transplantation in Knee Osteoarthritis Patients

To determine the effectiveness of muscle energy technique along conventional physical therapy after mesenchymal stem cell transplantation in knee Osteoarthritis patients regarding Pain, range of motion, functional disability and quality of life.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: CONVENTIONAL PHYSICAL THERAPY; Other: MUSCLE ENERGY TECHNIQUE

Detailed Description

Mesenchymal stem cells (MSCs) replacement is a regenerative therapeutic procedures for the early treatment of cartilaginous defects in knee osteoarthritis. MSCs may improve symptoms and function in osteoarthritic joints but also decrease inflammation and induce cartilage healing by differentiating into chondrocytes, osteoblasts and indicating appropriate extracellular matrix proteins (i.e. collagen I and II) through the secretion of cytokines, chemokines, and growth factors from MSCs.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad, Pakistan
    • Institute of Regenerative medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Both male and female
• Age > 40 years
• Knee osteoarthritis patients undergone mesenchymal stem cell transplantation.

Exclusion Criteria:

• History of recent or past septic arthritis
• Patients with neurological deficit
• Uncontrolled diabetes
• Malignancy
• Vascular insufficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CONVENTIONAL PHYSICAL THERAPY; TENS , Open chain knee flexion and extension, Calf stretch , Quad set	Other: CONVENTIONAL PHYSICAL THERAPY; High frequency TENS for 10 mins, 3 days/week Ankle pumps for blood circulation 10 repetitions x1 set, 3 days/week. Heel slides10 repetitions x1 set, 3 days/week. Open chain knee flexion and extension 10 repetitions x1 set, 3 days/week. SLR (straight leg raise) 10 repetitions x1 set, 3 days/week. Calf stretch 10 repetitions x1 set, 3 days/week. Quad set 10 repetitions x1 set, 3 days/week. Total 6 sessions each consisting of 30-45 minutes
Experimental: MUSCLE ENERGY TECHNIQUE; MET ( isometric contraction with 6-10 sec )	Other: MUSCLE ENERGY TECHNIQUE; Experimental group treated by applying Muscle energy technique along conventional physical therapy. For MET patient is positioned at maximal comfort and lengthening while engaging the barrier and then patient is asked to perform isometric contraction with 6-10 sec hold and then release and lengthen the muscle 4-5 repetition x 1 set, 3days/week Total 6 sessions each consisting of 30-45 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale (NPRS)	The Numeric Pain Rating Scale (NPRS) is the simplest and most commonly used numeric scale to rate the pain from 0 (no pain) to 10 (worst pain).	NPRS used to measure changes from baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used to measure symptoms and physical disability, originally developed for people with OA of the hip or knee. It evaluates three dimensions: pain, stiffness, and physical function with 5, 2, and 17 questions. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function, a total of 96, 0 (no symptoms/no limitation) and 96 (maximal symptoms/maximal limitation).	WOMAC index used to measure changes from baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.
Goniometer (range of motion)	Knee flexion and extension ranges were taken using goniometer to measure changes in ROM.	baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.
SF-12 (quality of life)	The SF-12 focuses on patient-based assessments of physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression.	SF-12 used to measure changes from baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: KINZA ANWAR, MS-OMPT, RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Actual): July 8, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation protocol; Mesenchymal stem cells (MSCs),; muscle energy technique (MET),
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: REC/01255 Fanila Ashraf

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