Knee OsteoarthritisNCT05349565
Effects of Muscle Energy Technique in Knee Osteoarthritis Patients
A study testing CONVENTIONAL PHYSICAL THERAPY and MUSCLE ENERGY TECHNIQUE in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 41 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- CONVENTIONAL PHYSICAL THERAPY and MUSCLE ENERGY TECHNIQUE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Sep 2022to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female
- Age > 40 years
- Knee osteoarthritis patients undergone mesenchymal stem cell transplantation.
Who cannot join
- History of recent or past septic arthritis
- Patients with neurological deficit
- Uncontrolled diabetes
- Malignancy
- Vascular insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- CONVENTIONAL PHYSICAL THERAPY, MUSCLE ENERGY TECHNIQUE
- Keywords
- Mesenchymal stem cells (MSCs),, muscle energy technique (MET),, rehabilitation protocol
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONVENTIONAL PHYSICAL THERAPYOther
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 TECHNIQUEOther
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
| Study group | Role | What they receive |
|---|---|---|
| CONVENTIONAL PHYSICAL THERAPY | Active comparator | TENS , Open chain knee flexion and extension, Calf stretch , Quad set Receives: Other: CONVENTIONAL PHYSICAL THERAPY |
| MUSCLE ENERGY TECHNIQUE | Experimental | MET ( isometric contraction with 6-10 sec ) Receives: Other: MUSCLE ENERGY TECHNIQUE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start13 Sep 2022
- Primary completion8 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KINZA ANWAR, MS-OMPT, Principal investigator, RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349565
- Sponsor's protocol ID
- REC/01255 Fanila Ashraf
- Status last verified
- Jul 2023
- First submitted
- 21 Apr 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Muscle Energy Technique Along Conventional Physical Therapy After Mesenchymal Stem Cell Transplantation in Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT05349565
- Acronym / sponsor ID
- REC/01255 Fanila Ashraf
- Conditions
- Knee Osteoarthritis
- Keywords
- Mesenchymal stem cells (MSCs),, muscle energy technique (MET),, rehabilitation protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 8 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONVENTIONAL PHYSICAL THERAPY | Active comparator | Other: CONVENTIONAL PHYSICAL THERAPYTENS , Open chain knee flexion and extension, Calf stretch , Quad set |
| MUSCLE ENERGY TECHNIQUE | Experimental | Other: MUSCLE ENERGY TECHNIQUEMET ( isometric contraction with 6-10 sec ) |
Who may qualify
- Ages
- 41 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both male and female
- Age > 40 years
- Knee osteoarthritis patients undergone mesenchymal stem cell transplantation.
Key exclusion criteria (5 listed)
- History of recent or past septic arthritis
- Patients with neurological deficit
- Uncontrolled diabetes
- Malignancy
- Vascular insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONVENTIONAL PHYSICAL THERAPYHigh 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 | Other | CONVENTIONAL PHYSICAL THERAPY |
| MUSCLE ENERGY TECHNIQUEExperimental 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 | Other | MUSCLE ENERGY TECHNIQUE |
Primary outcome
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).
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KINZA ANWAR, MS-OMPT principal investigator
RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONVENTIONAL PHYSICAL THERAPY and MUSCLE ENERGY TECHNIQUE in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.