NCT07403253

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

knee osteoarthritishamstring tightnesshamstring stretchingfascial distortion model

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    from enrollment to the end of treatment of 4 weeks

Secondary Outcomes (2)

  • Knee Flexion ROM

    from enrollment to the end of treatment at 4 weeks

  • Knee Extension ROM

    From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Fascial Distortion Model

EXPERIMENTAL
Other: Fascial Distortion ModelOther: Standardize Physiotherapy Treatment

Hamstring Stretching

ACTIVE COMPARATOR
Other: Hamstring StretchingOther: Standardize Physiotherapy Treatment

Interventions

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

Fascial Distortion Model

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

Hamstring Stretching

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.

Fascial Distortion ModelHamstring Stretching

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdul Ahaad hospital, Sialkot.

Sialkot, Punjab Province, 51310, Pakistan

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Rafia Mannan, MS-SPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

January 13, 2025

Primary Completion

May 31, 2025

Study Completion

October 31, 2025

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations