NCT06986694

Brief Summary

Knee osteoarthritis (KOA) is a prevalent degenerative joint disease characterized by pain, stiffness, and reduced physical function, significantly impacting quality of life especially in elderly population. This study aims to evaluating the effectiveness of an emerging technique, known as 'Voodoo Flossing' on pain, range of motion and physical function in KOA to provide evidence-based insight of voodoo flossing as a potential therapeutic adjunct in KOA management. This randomized controlled trial will be conducted at Riphah Rehabilitation Clinic, Lahore and Horizon Hospital Lahore in a time span of 8 months. A sample size of 42 subjects selected through non-probability convenient sampling with age group between 45 to 65 having present complain confirmed through Kellgren-Lawrence (KL) scale of grade-II will be divided into two groups, will undergo aerobic exercises, strengthening exercises and conventional physiotherapy protocol either with or without Voodoo Flossing technique.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

May 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

June 12, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

May 15, 2025

Last Update Submit

July 3, 2025

Conditions

Keywords

Knee OsteoarthritisPainPhysical FunctionPhysiotherapyRange of MotionVoodoo Flossing

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale

    Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain". In this study, participants rating ≥2 and ≤9 on NPRS will be taken.

    4th week

  • The Western Ontario and McMaster Universities Osteoarthritis Index

    WOMAC index is a widely used questionnaire designed to assess the three dimensions of pain, stiffness, and physical function in individuals with OA of the hip or knee. It is a 24-item questionnaire divided into three sub-categories: Pain (5 items), Stiffness (2 items), Physical Function (17 items). Participants having poor scoring on WOMAC scale for pain, stiffness and physical activities will be considered for this study.

    4th week

Secondary Outcomes (2)

  • Time Up & Go Test

    4th week

  • Universal Goniometer

    4th week

Study Arms (2)

Voodoo Flossing technique along with aerobic & strengthening exercises and conventional protocol.

EXPERIMENTAL

Patient will sit or lie down comfortably with affected knee exposed and in extension. Start by wrapping voodoo floss band at the shin bone just below the knee joint with 50% tension in the band and 50% overlapping on each wrap by working your way up towards the thigh. Keep the flossing band on for at least 1-2 minutes and perform gentle knee movements to promote mobility. * Knee flexion and extension in full range of motion in standing position 20-30 sec. * Knee squats with/without support 20-30 sec. * Abduction and Adduction 20-30 sec. Perform each exercise with 10-15 seconds of rest between each set. After completing ROM exercises, allow the knee to rest in comfortable position and then carefully unwrap the voodoo band from the knee joint. Also monitor the knee for any changes.

Other: Group A will receive Voodoo Flossing Technique along with aerobic and strengthening exercises & conventional physiotherapy protocol for Knee OA.

Aerobic and strength training and conventional physiotherapy protocol for knee OA.

ACTIVE COMPARATOR

Aerobic Exercises: Walking or Stationary Cycling 2 times a week for 4 weeks. Walking: On flat surface or Treadmill 10 minutes warm-up, 30 minutes brisk walking, 5 minutes cool down. Cycling: Ergometer cycling * 10 minutes warm-up, 30 minutes on moderate loading (75% of max. heart rate), 5 minutes cool down. Strengthening Exercises Conventional Exercise Program: 2 times per week for 4 weeks Heat Therapy Ultrasound Therapy * Static Quadriceps activation 10\*2 RM * SLR 10\*2 RM * VMO activation 10\*2 RM * Knee to Chest 5\*2 RM * Quads, Hams \& Calf stretches

Other: Group B will receive aerobic and strength training and conventional physiotherapy protocol for knee OA only.

Interventions

Patient will sit or lie down comfortably with affected knee exposed and in extension. Start by wrapping voodoo floss band at the shin bone just below the knee joint with 50% tension in the band and 50% overlapping on each wrap by working your way up towards the thigh. Keep the flossing band on for at least 1-2 minutes and perform gentle knee movements to promote mobility. * Knee flexion and extension in full range of motion in standing position 20-30 sec. * Knee squats with/without support 20-30 sec. * Abduction and Adduction 20-30 sec. Perform each exercise with 10-15 seconds of rest between each set. After completing ROM exercises, allow the knee to rest in comfortable position and then carefully unwrap the voodoo band from the knee joint. Also monitor the knee for any changes.

Voodoo Flossing technique along with aerobic & strengthening exercises and conventional protocol.

Aerobic Exercises: Walking or Stationary Cycling 2 times a week for 4 weeks Walking: On flat surface/Treadmill * 10 minutes warm-up, 30 minutes brisk walking, 5 minutes cool down. Cycling: Ergometer cycling * 10 minutes warm-up, 30 minutes on moderate loading (75% of max. heart rate), 5 minutes cool down. Strengthening Exercises: Quadriceps, Hamstrings, Hip Abductors, Adductors and Calf Muscles Strengthening and Balance Training 2 times a week for 4 weeks. * Hip Abduction in standing 8-10\*2 RM * Hip Adduction in standing 8-10\*2 RM * Knee Flexion and Extension in standing 10\*2 RM * Knee Squats 8-10\*2 RM * Sit/stand from chair 10\*2 RM * Step up and down 10\*2 RM * Heel raises 10\*2 RM * Hip Bridges 10\*2 RM Conventional Exercise Program: 2 times per week for 4 weeks Heat Therapy Ultrasound Therapy * Static Quads activation 10\*2 RM * SLR 10\*2 RM * VMO activation 10\*2 RM * Knee to Chest 5\*2 RM * Quadriceps, Hamstrings and Calf stretches 5\*2 RM

Aerobic and strength training and conventional physiotherapy protocol for knee OA.

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 45 and ≤ 65
  • Both Male and Female
  • Knee Pain persisting for at-least 3 months
  • Pain severity during walking ≥ 2/10 on a Numeric Pain Rating Scale
  • Walking and Balance (Mobility) problems according to Time Up \& Go (TUG) test
  • Poor scoring on WOMAC scale for pain, stiffness and physical activities
  • Knee OA Grade II (according to Kellgren-Lawrence method)
  • Participants must provide informed consent for participation in RCT

You may not qualify if:

  • Age \< 45 and \> 65
  • Severe Knee pain during Walking ≥ 9/10 on a Numeric Pain Rating Scale
  • Knee OA Grade I, III \& IV (according to Kellgren-Lawrence method)
  • Physical or Mental co-morbidity severely affecting daily life of patient
  • Any Contraindication to provide Exercise Therapy
  • Suspicion of chronic widespread pain (i.e., pain present for at least 3 months in at least three joints including left and right side of the body, above and below the waist, and the axial skeleton)
  • Participant undergone total knee arthroplasty or on waiting list for total knee arthroplasty in any knee
  • Any other reasons for knee pain than knee OA (e.g., rheumatoid arthritis and gout)
  • Received intraarticular injections in past 6 months because of knee pain (Hyaluronic Gel or steroid)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Horizon Hospital

Lahore, Punjab Province, 54782, Pakistan

RECRUITING

Related Publications (5)

  • Acar S, Aljumaa H, Sevik K, Karatosun V, Unver B. The Intrarater and Interrater Reliability and Validity of Universal Goniometer, Digital Inclinometer, and Smartphone Application Measuring Range of Motion in Patients with Total Knee Arthroplasty. Indian J Orthop. 2024 Apr 19;58(6):732-739. doi: 10.1007/s43465-024-01129-z. eCollection 2024 Jun.

    PMID: 38812867BACKGROUND
  • Oiestad BE, Aroen A, Rotterud JH, Osteras N, Jarstad E, Grotle M, Risberg MA. The efficacy of strength or aerobic exercise on quality of life and knee function in patients with knee osteoarthritis. A multi-arm randomized controlled trial with 1-year follow-up. BMC Musculoskelet Disord. 2023 Sep 8;24(1):714. doi: 10.1186/s12891-023-06831-x.

    PMID: 37684597BACKGROUND
  • Kelly CF, Oliveri Z, Saladino J, Senatore J, Kamat A, Zarour J, Douris PC. The Acute Effect of Tissue Flossing on Pain, Function, and Perception of Movement: A Pilot Study. Int J Exerc Sci. 2023 Jul 1;16(3):855-865. doi: 10.70252/OKAO5505. eCollection 2023.

    PMID: 37637031BACKGROUND
  • Tore NG, Oskay D, Haznedaroglu S. The quality of physiotherapy and rehabilitation program and the effect of telerehabilitation on patients with knee osteoarthritis. Clin Rheumatol. 2023 Mar;42(3):903-915. doi: 10.1007/s10067-022-06417-3. Epub 2022 Oct 24.

    PMID: 36279075BACKGROUND
  • Geng R, Li J, Yu C, Zhang C, Chen F, Chen J, Ni H, Wang J, Kang K, Wei Z, Xu Y, Jin T. Knee osteoarthritis: Current status and research progress in treatment (Review). Exp Ther Med. 2023 Aug 25;26(4):481. doi: 10.3892/etm.2023.12180. eCollection 2023 Oct.

    PMID: 37745043BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hira Shaukat, TDPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 15, 2025

First Posted

May 23, 2025

Study Start

June 12, 2025

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations