Effects of Muscle Energy Technique in Knee Osteoarthritis Patients
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
CONVENTIONAL PHYSICAL THERAPY
MUSCLE ENERGY TECHNIQUE
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Mesenchymal stem cells (MSCs),, muscle energy technique (MET),, rehabilitation protocol
Eligibility Criteria
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
Sites / Locations
- Institute of Regenerative medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CONVENTIONAL PHYSICAL THERAPY
MUSCLE ENERGY TECHNIQUE
Arm Description
TENS , Open chain knee flexion and extension, Calf stretch , Quad set
MET ( isometric contraction with 6-10 sec )
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Goniometer (range of motion)
Knee flexion and extension ranges were taken using goniometer to measure changes in ROM.
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.
Full Information
NCT ID
NCT05349565
First Posted
April 21, 2022
Last Updated
July 12, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05349565
Brief Title
Effects of Muscle Energy Technique in Knee Osteoarthritis Patients
Official Title
Effects of Muscle Energy Technique Along Conventional Physical Therapy After Mesenchymal Stem Cell Transplantation in Knee Osteoarthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
July 8, 2023 (Actual)
Study Completion Date
July 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Mesenchymal stem cells (MSCs),, muscle energy technique (MET),, rehabilitation protocol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CONVENTIONAL PHYSICAL THERAPY
Arm Type
Active Comparator
Arm Description
TENS , Open chain knee flexion and extension, Calf stretch , Quad set
Arm Title
MUSCLE ENERGY TECHNIQUE
Arm Type
Experimental
Arm Description
MET ( isometric contraction with 6-10 sec )
Intervention Type
Other
Intervention Name(s)
CONVENTIONAL PHYSICAL THERAPY
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
MUSCLE ENERGY TECHNIQUE
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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).
Time Frame
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 Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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).
Time Frame
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.
Title
Goniometer (range of motion)
Description
Knee flexion and extension ranges were taken using goniometer to measure changes in ROM.
Time Frame
baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.
Title
SF-12 (quality of life)
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KINZA ANWAR, MS-OMPT
Organizational Affiliation
RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Regenerative medicine
City
Islamabad
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Muscle Energy Technique in Knee Osteoarthritis Patients
We'll reach out to this number within 24 hrs