- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07403253
Comparative Effects of Fascial Distortion Model and Hamstring Stretching in Patients With Knee Osteoarthritis.
February 4, 2026 updated by: Riphah International University
Comparative Effects of Fascial Distortion Model and Hamstring Stretching on Pain, Muscle Flexibility and Physical Function in Patients With Knee Osteoarthritis.
The study was conducted to compare the effects of Fascial Distortion Model and Hamstring Stretching on pain, muscle flexibility and physical function in patients with Knee Osteoarthritis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab Province
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Sialkot, Punjab Province, Pakistan, 51310
- Abdul Ahaad hospital, Sialkot.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Inclusion Criteria:
- Patient aged 40-60 years old of both genders.
- X-ray showing unilateral degenerative changes in Knee joint.
- Knee osteoarthritis stage 2 and stage 3 was included.
- A score of 3 to 7 on the numeric pain rating scale (NPRS).
- Patients with positive 90-90 hamstring flexibility test by using goniometer.
Exclusion Criteria:
- Recent fracture.
- The participants with any neurological disorder that impacts the lower extremity, Musculoskeletal knee deformity e.g. varus or valgus knee deformity, lower limb internal fixation etc .
- History of lower limb arthroplasty or knee surgery.
- Patients with body mass index (BMI) more than 35 were excluded.
- Previous history of malignancy or any infectious disease.
- Subjects having sciatica or low back pain were excluded from the study .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Fascial Distortion Model
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Put direct pressure on the fascia's taut band.
The pressure should be just right, firm enough to activate the tissue without causing undue pain or discomfort.
The pressure is usually extended across the bands length, or perpendicular to the direction of the band's fibers.
Each stroke of the treatment might take between 10 to 30 seconds, depending on the severity of fascial distortion.
A typical rule is to work through the band gently and consistently, without rushing, to allow the tissues time to respond.
Treatment might be applied for 5 to 10 minutes, 2-3 times per week for 4 weeks
Hot pack for 10 minutes.
TENS with frequency of 2Hz and pulse duration of 50-200 μs for 10 minutes and Knee strengthening exercise consists of (Isometric quadriceps strengthening exercise, straight leg raises, partial squatting exercise, knee extensor strength exercise) 10 repetition per set, 3 sets per sessions, 3 times in a week for 4 weeks.
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Active Comparator: Hamstring Stretching
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Hot pack for 10 minutes.
TENS with frequency of 2Hz and pulse duration of 50-200 μs for 10 minutes and Knee strengthening exercise consists of (Isometric quadriceps strengthening exercise, straight leg raises, partial squatting exercise, knee extensor strength exercise) 10 repetition per set, 3 sets per sessions, 3 times in a week for 4 weeks.
With your legs relaxed and straight, lie on your back.
Wrap a towel or strap under your foot arch, around your hamstring, or around your calf.
Pull your leg gently in your direction until it stretches.
It also entails stretching with the aid of an outside force, such as gravity or a partner.
This position was held for 30 seconds, for 3 sets per sessions, 3 times in a week for 4 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Western Ontario and McMaster Universities Arthritis Index (WOMAC):
Time Frame: from enrollment to the end treatment of 4 weeks
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It is frequently used to assess osteoarthritis in the knee and hips. It is self- administered survey with three subscales and 24 items:
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from enrollment to the end treatment of 4 weeks
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Numeric Pain Rating Scale (NRRS)
Time Frame: from enrollment to the end of treatment at 4 weeks
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The NPRS was used to gauge the patient's degree of pain.
On a 0-10 scale, where 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-10 represents severe pain, this tool is frequently used to gauge the intensity of pain.
Patients rate how much pain they are currently experiencing as well as how much pain they had experienced in the past 24 hours.
The patient's level of pain may be represented by average of the three evaluations or by any one rating.
NPRS reliability is 0.96 and validity is 0.86.
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from enrollment to the end of treatment at 4 weeks
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90 -90 HAMSTRING FLEXIBILITY TEST
Time Frame: from enrollment to the end of treatment of 4 weeks
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The individual is in supine position with their arms folded across their chest their head back.
If a spirit level is available, use it to passively flex the hi until the thigh is vertical.
Throughout the test, keep the opposing leg fully extended while maintaining this thigh position.
The leg being tested is actively straightened until the thigh starts to deviated from the vertical position, while the foot is kept relaxed.
At this point, the thigh angle is noted.
When the thigh is vertical, measure the minimum angle of knee flexion.
Degrees are the unit of measurement.
The angle would be reported as 0 if the leg could be fully straightened.
Any amount of flexion, such as 10 to 20 degrees, will be noted as a positive number.
Muscle tension is indicated by a value greater than 20 degrees.
The knee is flexed the thigh is pushed 30 degrees past in the vertical position and the knee is straightened once more in situation where complete knee extension is accomplished without thigh movement.
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from enrollment to the end of treatment of 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Knee Flexion ROM
Time Frame: from enrollment to the end of treatment at 4 weeks
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Changes in knee flexion ROM at baseline and 4th week of intervention was measured using goniometer.
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from enrollment to the end of treatment at 4 weeks
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Knee Extension ROM
Time Frame: From enrollment to the end of treatment at 4 weeks
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Changes in knee extension ROM at baseline and 4th week of intervention was measured using goniometer.
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From enrollment to the end of treatment at 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rafia Mannan, MS-SPT, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mahmoud, W.S., et al., Radiological and clinical outcomes of concurrent hamstring stretching with quadriceps strengthening in patients with knee osteoarthritis: A randomized clinical trial. Isokinetics and Exercise Science, 2023. 31(2): p. 137-147.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2025
Primary Completion (Actual)
May 31, 2025
Study Completion (Actual)
October 31, 2025
Study Registration Dates
First Submitted
February 4, 2026
First Submitted That Met QC Criteria
February 4, 2026
First Posted (Actual)
February 11, 2026
Study Record Updates
Last Update Posted (Actual)
February 11, 2026
Last Update Submitted That Met QC Criteria
February 4, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/01106
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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