NCT07402408

Brief Summary

The aim of this study was to compare the effect of band tissue flossing method and traditional cuff method for blood flow restriction training on pain, range of motion, muscle strength and functional status in patients with knee osteoarthritis. Symptoms of this condition limit patient's ability to perform high load strengthening. Blood flow restraining training allows strengthening with lower loads. 46 subjects will be divided in two groups, 23 subjects in each group. knee extension and knee press exercises will be performed. In group A floss band was tied on thigh and in group B pneumatic cuff was applied on thigh. 40-60 years individual with knee osteoarthritis will be included. outcome measures will be assessed at baseline, after 1st session, after 2nd week and after 4th week.

Trial Health

63
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Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Mar 2026

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 Progress92%
Mar 2026Jun 2026

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
18 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2026

Expected
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

February 4, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

Blood flow restriction therapyKnee OsteoarthritisRange of Motion

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale (NPRS)

    Changes from baseline will be assessed using NPRS scale. It is a one-dimensional measure of pain severity in adults including those suffering from chronic pain. Scale has ratings of 0 to 10, with higher points indicating higher levels of pain severity. it is a valid tool for assessing pain in knee OA patients.

    4th week

Secondary Outcomes (6)

  • Knee Flexion Range of motion

    4th week

  • Knee Extension Range of Motion

    4th week

  • Quadriceps strength (dynamometer)

    4th week

  • Western Ontario and McMaster Universities (WOMAC) index

    4th week

  • 30 Second Sit to Stand Test (STS)

    4th week

  • +1 more secondary outcomes

Study Arms (2)

Blood flow restriction with Floss band (group A)

EXPERIMENTAL

seated knee extension and knee press while floss band is tied at proximal thigh.

Other: Blood flow restriction training with Floss band

Blood flow restriction with pneumatic cuff (group B)

EXPERIMENTAL

seated knee extension and knee press exercises with pneumatic cuff tied at proximal thigh

Other: Blood flow restriction training with pneumatic cuff

Interventions

seated knee extension exercise and knee press exercises (4 sets; repetitions: 30,15,15,15) performed for four weeks with three sessions per week. Exercises performed with 20% of one repetition maximum. Floss band was tied at proximal thigh with 50% stretch in proximal to distal direction starting from above the patella and moving towards groin.

Blood flow restriction with Floss band (group A)

seated knee extension exercises and knee press exercises (4 sets; repetitions: 30,15,15,15) performed for four weeks with three sessions per week. Exercises performed with 20% of one repetition maximum. Clinical cuff was tied at proximal thigh with 40% of limb occlusion pressure.

Blood flow restriction with pneumatic cuff (group B)

Eligibility Criteria

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

You may qualify if:

  • Age 40-60 years
  • Pain more than or equal to 3 on NPRS
  • Range of motion ≤ 100-degree flexion and ≤ 0-degree extension
  • Those who have knee osteoarthritis, according to KL (Grade 1 and 2)
  • Genders: Male and Female

You may not qualify if:

  • Cardiovascular condition e.g., hypertension, thromboembolism, lymphatic diseases etc.
  • Muscle/tendon/ ligament injuries
  • Any surgery, skin infection, trauma, pregnancy, fracture and fall
  • Patient with intra articular steroidal therapy with in last 6 months
  • Patient unwilling to participate and comply with the study session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Institute of Medical Sciences (P.I.M.S.)

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Muhammad Affan Iqbal, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
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

March 1, 2026

Primary Completion

June 15, 2026

Study Completion (Estimated)

June 25, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations