NCT07181421

Brief Summary

Knee osteoarthritis (OA) is a common degenerative joint disease that primarily affects individuals aged 40 years and older, and results in painful symptoms along with limited range of motion (ROM) and muscle weakness(1). Therapeutic exercise covers a range of targeted physical activities that directly aim to improve muscle strength, neuromotor control, joint range of motion and aerobic fitness. One of the main aims of exercise is to improve muscle strength, given that weakness is common in knee OA. Exercise, especially isometric ROM exercises and step-ups as therapeutic exercise, are very important in OA patients, because they not only maintain the activity of the joint but also treat the pain and strengthen the joint (2).Use of tissue flossing, in which an elastic band is wrapped around muscles and joints to enhance blood flow and reduce pain(3).It has been on the rise as an adjunct to rehabilitation, but its efficacy when combined with therapeutic exercise is not well-known. The objective of this non-blinded randomized controlled trial is to compare the effects of tissue flossing combined with therapeutic exercises versus therapeutic exercises alone on pain, ROM, and muscle strength in patients with knee OA. The study will be conducted over a period of 4 weeks, with two sessions per week at Sheikh Khalifa Bin Zayed Hospital, Quetta. Initially, participants aged 40-70 years with diagnosed Grade 1,2and 3 knee OA will be screened for eligibility based on inclusion and exclusion criteria. Eligible participants will be informed about the study objectives and procedures, and written informed consent will be obtained. Participants will then be randomly allocated into two groups using the envelope method for group randomization. Baseline assessment will include knee ROM measurement, muscle strength assessment using Manual Muscle Testing (MMT), pain evaluation using the Numeric Pain Rating Scale (NPRS), Group A will receive tissue flossing in addition to therapeutic exercises, while Group B will receive only therapeutic exercises. All outcome measures will be reassessed after 4 weeks of intervention to evaluate the effects of the intervention. Data will be entered and analyzed using SPSS v.22.

Trial Health

63
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Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Sep 2025Aug 2026

First Submitted

Initial submission to the registry

September 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 12, 2025

Last Update Submit

September 12, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Knee Pain

    Numeric pain rating scale will be used to measure knee pain

    4 weeks

  • Knee Range of Motion

    Goniometer willl be used to measure knee range of motion

    4 weeks

  • Knee Muscle Strength

    Manual Muscle Testing will be used for knee muscle strength

    4 weeks

Study Arms (2)

Tissue Flossing and Therapeutic Exercises

EXPERIMENTAL

Detailed of tissue flossing and therapeutic exercises.: The floss band will be kept on for 2 minutes, and during this time, the patient will perform the exercises with progression. After each 2-minute flossing session, the patient will rest for 2 minutes.

Procedure: Tissue flossing with Therapeutic exercises

Therapeutic Exercises only

ACTIVE COMPARATOR

Isometric Knee Extension - Standing Hamstring Curl - Wall Squats - Leg Press Against Wall

Procedure: Therapeutic Exercises

Interventions

Isometric Knee Extension - Standing Hamstring Curl - Wall Squats - Leg Press Against Wall. The Red TheraBand from Thera Tool (2m \* 5cm \* 1.3mm) will be used. The band will be wrapped starting from the tibial tuberosity and extending to 5 cm above the femoral epicondyle. Care will be taken to ensure that the patella remains uncovered. * The band will be wrapped with 50% tension and 50% overlap. * Flossing Duration: The floss band will be kept on for 2 minutes, and during this time, the patient will perform the exercises mentioned above. The number of repetitions for each exercise will depend on the patient's tolerance level, with a reference of 10 repetitions per exercise (based on similar tissue flossing protocols, though adapted for knee OA patients).

Tissue Flossing and Therapeutic Exercises

Isometric Knee Extension - Standing Hamstring Curl - Wall Squats - Leg Press Against Wall.

Therapeutic Exercises only

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 40-70 years with diagnosed knee OA (Grades 1 and 2). Unilateral knee OA or if bilateral OA is present, only the more symptomatic knee (Grade 1 or 2) Willingness to comply with the intervention protocol. Both Genders

You may not qualify if:

  • Higher grade 3 and 4 knee OA. Recent knee surgeries Soft tissue injury of lower limb less than six months prior to the study Neurological or cardiovascular conditions contraindicating exercise Ongoing participation in another knee Rehabilitation program Latex allergy or Skin diseases varicose veins and Thrombosis Diabetic Neuropathy Fractures and open wounds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 18, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations