Knee OsteoarthritisNCT07403253
Comparative Effects of Fascial Distortion Model and Hamstring Stretching in Patients With Knee Osteoarthritis.
A study testing Fascial Distortion Model, Hamstring Stretching and Standardize Physiotherapy Treatment in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Fascial Distortion Model, Hamstring Stretching and Standardize Physiotherapy Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jan 2025to 31 Oct 2025
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Abdul Ahaad hospital, Sialkot.
Sialkot, Punjab Province, 51310
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Fascial Distortion Model, Hamstring Stretching, Standardize Physiotherapy Treatment
- Keywords
- knee osteoarthritis, hamstring tightness, hamstring stretching, fascial distortion model
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial Distortion ModelOther
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
Hamstring StretchingOther
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
Standardize Physiotherapy TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fascial Distortion Model | Experimental | Not described Receives: Other: Fascial Distortion Model; Other: Standardize Physiotherapy Treatment |
| Hamstring Stretching | Active comparator | Not described Receives: Other: Hamstring Stretching; Other: Standardize Physiotherapy Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC):
It is frequently used to assess osteoarthritis in the knee and hips. It is self- administered survey with three subscales and 24 items:
- Pain (5 items): walking, climbing stairs, lying down or sitting, lying in bed and standing up straight.
- Physical function (17 items): using stairs, getting up from sitting, standing, bending, walking, getting in and out of car, shopping, putting on or taking off socks, getting in and out of a bath, sitting, getting on and off the toilet, heavy domestic duties, and light domestic duties.
- Stiffness (2 items): after first waking and later in the day. A possible score ranges of 0-20 for pain, 0-8 for stiffness and 0-68 for physical function is obtained by adding the score for each subscale. The overall WOMAC score ranges from 0-96, with 0 denoting the highest potential for health and 96 the worst. The function is worse, the higher the score.
Measured: from enrollment to the end treatment of 4 weeks
Numeric Pain Rating Scale (NRRS)
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.
Measured: from enrollment to the end of treatment at 4 weeks
90 -90 HAMSTRING FLEXIBILITY TEST
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.
Measured: from enrollment to the end of treatment of 4 weeks
Secondary outcomes (2)
Knee Flexion ROM
Changes in knee flexion ROM at baseline and 4th week of intervention was measured using goniometer.
Measured: from enrollment to the end of treatment at 4 weeks
Knee Extension ROM
Changes in knee extension ROM at baseline and 4th week of intervention was measured using goniometer.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start13 Jan 2025
- Primary completion31 May 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafia Mannan, MS-SPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403253
- Sponsor's protocol ID
- REC/RCR & AHS/24/01106
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Fascial Distortion Model and Hamstring Stretching on Pain, Muscle Flexibility and Physical Function in Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT07403253
- Acronym / sponsor ID
- REC/RCR & AHS/24/01106
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, hamstring tightness, hamstring stretching, fascial distortion model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 11 Feb 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascial Distortion Model | Experimental | Other: Fascial Distortion Model, Other: Standardize Physiotherapy Treatment |
| Hamstring Stretching | Active comparator | Other: Hamstring Stretching, Other: Standardize Physiotherapy Treatment |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Fascial Distortion ModelPut 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 | Other | Fascial Distortion Model |
| Hamstring StretchingWith 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 | Other | Hamstring Stretching |
| Standardize Physiotherapy TreatmentHot 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. | Other | Fascial Distortion Model, Hamstring Stretching |
Primary outcome
The Western Ontario and McMaster Universities Arthritis Index (WOMAC):
Time frame: from enrollment to the end treatment of 4 weeks
It is frequently used to assess osteoarthritis in the knee and hips. It is self- administered survey with three subscales and 24 items: * Pain (5 items): walking, climbing stairs, lying down or sitting, lying in bed and standing up straight. * Physical function (17 items): using stairs, getting up from sitting, standing, bending, walking, getting in and out of car, shopping, putting on or taking off socks, getting in and out of a bath, sitting, getting on and off the toilet, heavy domestic duties, and light domestic duties. * Stiffness (2 items): after first waking and later in the day. A possible score ranges of 0-20 for pain, 0-8 for stiffness and 0-68 for physical function is obtained by adding the score for each subscale. The overall WOMAC score ranges from 0-96, with 0 denoting the highest potential for health and 96 the worst. The function is worse, the higher the score.
Numeric Pain Rating Scale (NRRS)
Time frame: from enrollment to the end of treatment at 4 weeks
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.
90 -90 HAMSTRING FLEXIBILITY TEST
Time frame: from enrollment to the end of treatment of 4 weeks
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.
2 secondary outcomes
Knee Flexion ROM
Time frame: from enrollment to the end of treatment at 4 weeks
Knee Extension ROM
Time frame: From enrollment to the end of treatment at 4 weeks
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 11 Feb 2026.
- BackgroundMahmoud, 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.
- Individual participant dataSharing planned: No
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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.
Rafia Mannan, MS-SPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial Distortion Model, Hamstring Stretching and Standardize Physiotherapy Treatment 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 5 inclusion and 6 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 11 Feb 2026. 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?
The Western Ontario and McMaster Universities Arthritis Index (WOMAC): (time frame: from enrollment to the end treatment of 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07403253, which also lists 1 linked publication.
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 11 Feb 2026.