Clinical trial NCT06986694: Effects of Voodoo Flossing Technique in Knee Osteoarthritis Patients
Official title: Effects of Voodoo Flossing Technique on Pain, Range of Motion and Physical Function in Patients With Knee Osteoarthritis: A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Pain
Range of Motion
Physiotherapy
Keywords: Knee Osteoarthritis
Pain
Physical Function
Physiotherapy
Range of Motion
Voodoo Flossing
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 42
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A double blinded randomized controlled trial has been conducted to investigate the effectiveness of integrating flossing band therapy with conventional physiotherapy, anticipating outcomes of pain reduction, functional ability, and patient satisfaction. Outcomes were measured for pain (VAS), strength (Dynamometry), lower limb function (LEFS) and PFPS function (AKPS) before and after intervention stating flossing band integrated with physiotherapy as more effective treatment modality for PFPS.

A study has been conducted to check the effectiveness of voodoo flossing on pain and functional recovery in shin splint on amateur runners. Pre and post-test measurements were taken showing voodoo flossing as an effective technique for reducing pain and improving pain free activities in management of Shin Splint Syndrome in amateur runners.

A randomized control trial aimed to compare the lasting effects of the flossing band (FB) technique, dynamic stretching (DS) and static stretching (SS) on hamstring, on knee ROM, muscle activity, and proprioception to identify the most effective pre-exercise method for preventing injuries. FB group shows improvements in joint ROM and muscle activity as compared to DS and SS groups and exhibited lasting effects. Also, the proprioception observed at 30°, 60°, and 90° knee flexion had the smallest repositioning error in the FB group. Previous researches have shown positive aspects of voodoo flossing combined with physiotherapy on ankle joint, shoulder joint, shin splints, PFPS, knee ROM, proprioception, muscle functionality but evidence of its application in knee OA patients is scarce. By systematically addressing these gaps through well designed RCTs and comprehensive outcome assessments, future research can provide evidence-based insight of voodoo flossing as a potential therapeutic adjunct in KOA management. This study aims to address this existing literature gap by elucidating its potential effects on knee pain, ROM and physical function in KOA patients and making future recommendations for further study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 4th week
measure: The Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 4th week
Secondary outcomes:
measure: Time Up & Go Test
timeFrame: 4th week
measure: Universal Goniometer
timeFrame: 4th week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Horizon Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hira Shaukat, TDPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.