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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • Punjab Province
      • Sialkot, Punjab Province, Pakistan, 51310
        • Abdul Ahaad hospital, Sialkot.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fascial Distortion Model
Other: Fascial Distortion Model
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
Other: Standardize Physiotherapy Treatment
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.
Active Comparator: Hamstring Stretching
Other: Standardize Physiotherapy Treatment
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.
Other: Hamstring Stretching
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

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.
from enrollment to the end treatment of 4 weeks
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.
from enrollment to the end of treatment at 4 weeks
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.
from enrollment to the end of treatment of 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knee Flexion ROM
Time Frame: from enrollment to the end of treatment at 4 weeks
Changes in knee flexion ROM at baseline and 4th week of intervention was measured using goniometer.
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
Changes in knee extension ROM at baseline and 4th week of intervention was measured using goniometer.
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings