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Completed

NCT Number: NCT05349565

Effects of Muscle Energy Technique 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.

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Key information

Conditions

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

Age range

41 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Regenerative medicine

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Conventional physical therapy

Other

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

Other

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 outcomes

  1. Numeric Pain Rating Scale (NPRS)

    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.

    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 outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    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.

    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).

  2. Goniometer (range of motion)

    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.

    Knee flexion and extension ranges were taken using goniometer to measure changes in ROM.

  3. SF-12 (quality of life)

    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.

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2022
Registry last updated
Jul 13, 2023

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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