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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Pakistan

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.

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 groups in NCT07403253
Study groupRoleWhat they receive
Fascial Distortion ModelExperimentalNot described
Receives: Other: Fascial Distortion Model; Other: Standardize Physiotherapy Treatment
Hamstring StretchingActive comparatorNot 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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.

  1. First posted11 Feb 2026
  2. Study start13 Jan 2025
  3. Primary completion31 May 2025
  4. Study completion31 Oct 2025

Resources

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)
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.

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.

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