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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05349565
Other study ID # REC/01255 Fanila Ashraf
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 13, 2022
Est. completion date July 10, 2023

Study information

Verified date July 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date July 10, 2023
Est. primary completion date July 8, 2023
Accepts healthy volunteers No
Gender All
Age group 41 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Pakistan Institute of Regenerative medicine Islamabad

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
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