- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07639918
Effect of Kinesio-taping With Routine Physical Therapy in Wrist Joint Hypermobility
Routine Physical Therapy With and Without Kinesio Taping Among Patients With Wrist Joint Hypermobility
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Screening: All participants will be screened according to inclusion and exclusion criteria. Eligible individuals will provide written informed consent prior to participation.
Randomization & Allocation: Participants will be randomized into two groups using the lottery method.
Blinding: This will be a single-blind study in which the assessor will be blinded to group allocation.
Group A (Control): Participants will receive routine physical therapy treatment including Transcutaneous Electrical Nerve Stimulation (TENS), cryotherapy (if swelling), splinting recommendations, passive or active Range of Motion (ROM), strengthening, proprioceptive, dynamic and functional training exercises. Sessions will last 45 minutes, 3 times per week for 8 weeks.
Group B (Experimental): Participants will receive the same routine physical therapy protocol, plus Kinesio taping (Y-strip method) applied to the wrist joint. Each session will last 45 minutes, 3 times per week for 8 weeks.
Outcome Variables:
- Pain will be measured with the Numeric Pain Rating Scale (NPRS).
- Wrist Functionality with the Patient-Rated Wrist Evaluation (PRWE)
- Wrist range of motion with a universal Goniometer. Assessments will be done at baseline and after 8 weeks.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 55150
- University of Lahore Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female participants
- Aged 18 to 40 years.
- Beighton score greater than or equal to 4 either less than 4 with positive family history of hypermobility
- Intermittent or persistent wrist pain in one or both hands for more than 3 years.
- Passive range of motion less than 50 degree in wrist extension
Exclusion Criteria:
- Surgical history on wrist joint and upper limb in past 12 months.
- Inflammatory and infectious joint diseases like rheumatoid arthritis, wrist OA.
- Acute trauma or neurological conditions including radiculopathy, plexopathy, tunnel syndromes.
- Current or past use of splints or pain-related medications.
- Medication influencing joint mobility including corticosteroids, HRT, lipid-lowering drugs.
- Pregnant women and those less than 1 year postpartum
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: A - Control (Routine Physical Therapy)
Participants in this arm will receive the routine physical therapy protocol for wrist joint hypermobility.
Treatment includes pain-modality management (Transcutaneous Electrical Nerve Stimulation (TENS) or cryotherapy depending on swelling), wrist joint passive and active range of motion exercises, strengthening exercises, proprioceptive training, dynamic strengthening, grip training, and task-specific functional exercises.
A structured home-exercise plan is also provided.
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The routine physical therapy protocol includes: Transcutaneous Electrical Nerve Stimulation (TENS): 10 minutes (80 Hz, pulse width 50-100 µs); avoided if swelling is present. Cryotherapy: Used when swelling is present. Splinting: Static splints recommended for rest or night; dynamic splints for activity (as needed). Passive & Active Range of Motion (ROM) Exercises: Flexion, extension, radial and ulnar deviation (3 sets of 7 repetitions). Manual Resistance Strengthening: Flexion, extension, radial and ulnar deviation (3 sets of 10 repetitions). Wrist Curls and Reverse Wrist Curls: 0.5-1 kg weight (3 sets of 7 repetitions). Proprioceptive Training: Wrist circles, tendon gliding (3 sets of 10 repetitions). Dynamic Strengthening: Resistance band flexion and extension (3 sets of 12 repetitions). Grip Strengthening: Soft ball/Thera putty (3 sets of 10 reps) Functional Training: Task-specific activities for 5 minutes. Frequency: 3 sessions per week for 8 weeks. Session Duration: 45 minutes
Other Names:
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Experimental: B - Experimental (Routine Physical Therapy with Kinesio Taping)
Participants in this arm will receive the same routine physical therapy protocol as Arm 1, with the addition of Kinesio taping applied to the wrist using a standardized "Y-strip" method.
Kinesio tape is applied in the final 10 minutes of each session.
|
Kinesio taping will be applied in "Y" configuration using 5-cm elastic therapeutic tape. Procedure:
Patient checks wrist movement for comfort. Tape should remain dry for one hour post-application. Session details (combined): 45-minute sessions Heat pack or TENS for 10 minutes (if no swelling) ROM, strengthening, proprioception, dynamic training Tape applied in final 10 minutes Frequency: 3 sessions/week for 8 weeks A complete home-exercise program is also provided. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline and at the end of 8 weeks
|
The Numeric Pain Rating Scale (NPRS) is an 11 point scale used to assess wrist pain intensity, ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain.
Higher scores indicate greater pain intensity.
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Baseline and at the end of 8 weeks
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Patient Rated Wrist Evaluation (PRWE)
Time Frame: Baseline and at the end of 8 weeks
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The Patient Rated Wrist Evaluation (PRWE) questionnaire is a self reported questionnaire used to assess wrist pain and functional disability.
The total score ranges from 0 to 100, with higher scores indicating greater pain and disability.
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Baseline and at the end of 8 weeks
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Wrist Range of Motion
Time Frame: Baseline and at the end of 8 weeks
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Wrist range of motion will be measured using a universal goniometer in degrees for wrist flexion, extension, radial deviation, and ulnar deviation.
Higher values indicate greater wrist mobility.
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Baseline and at the end of 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Saliha Javed, MS-MSK, University of Lahore
Publications and helpful links
General Publications
- Farhadian M, Morovati Z, Shamsoddini A. Effect of Kinesio Taping on Pain, Range of Motion, Hand Strength, and Functional Abilities in Patients with Hand Osteoarthritis: A Pilot Randomized Clinical Trial. Arch Bone Jt Surg. 2019 Nov;7(6):551-560.
- Daman M, Shiravani F, Hemmati L, Taghizadeh S. The effect of combined exercise therapy on knee proprioception, pain intensity and quality of life in patients with hypermobility syndrome: A randomized clinical trial. J Bodyw Mov Ther. 2019 Jan;23(1):202-205. doi: 10.1016/j.jbmt.2017.12.012. Epub 2017 Dec 15.
- Kim GS, Weon JH, Kim MH, Koh EK, Jung DY. Effect of weight-bearing wrist movement with carpal-stabilizing taping on pain and range of motion in subjects with dorsal wrist pain: A randomized controlled trial. J Hand Ther. 2020 Jan-Mar;33(1):25-33. doi: 10.1016/j.jht.2019.02.001. Epub 2019 Mar 11.
- Luder G, Aeberli D, Mebes CM, Haupt-Bertschy B, Baeyens JP, Verra ML. Effect of resistance training on muscle properties and function in women with generalized joint hypermobility: a single-blind pragmatic randomized controlled trial. BMC Sports Sci Med Rehabil. 2021 Feb 8;13(1):10. doi: 10.1186/s13102-021-00238-8.
- Jung KS, Jung JH, Shin HS, Park JY, In TS, Cho HY. The Effects of Taping Combined with Wrist Stabilization Exercise on Pain, Disability, and Quality of Life in Postpartum Women with Wrist Pain: A Randomized Controlled Pilot Study. Int J Environ Res Public Health. 2021 Mar 30;18(7):3564. doi: 10.3390/ijerph18073564.
- Chaiparinya P, Gaogasigam C. Prevalence, frontal plane knee alignment, and lower limb joint pain and injury in generalized joint hypermobility in Thai physical therapy students. Reumatologia. 2022;60(2):116-124. doi: 10.5114/reum.2022.115621. Epub 2022 May 18.
- Chanthana P, Atthakomol P, Manosroi W, Wongpakaran T, Kraisarin J, Sananpanich K. Comparison of patient preferences and responsiveness among common patient-reported outcome measures for hand/wrist injuries or disorders. J Orthop Traumatol. 2023 Jan 9;24(1):2. doi: 10.1186/s10195-022-00681-4.
- Ituen OA, Anieto EM, Ferguson G, Duysens J, Smits-Engelsman B. Prevalence and Demographic Distribution of Hypermobility in a Random Group of School-Aged Children in Nigeria. Healthcare (Basel). 2023 Apr 11;11(8):1092. doi: 10.3390/healthcare11081092.
- Oruk DO, Karakaya MG, Yenisehir S, Karakaya IC. Effect of Kinesio taping on wrist kinematics and functional performance: A randomized controlled trial. J Hand Ther. 2023 Jan-Mar;36(1):3-12. doi: 10.1016/j.jht.2021.09.005. Epub 2021 Oct 27.
- Campos-Villegas C, Perez-Alenda S, Carrasco JJ, Igual-Camacho C, Tomas-Miguel JM, Cortes-Amador S. Effectiveness of proprioceptive neuromuscular facilitation therapy and strength training among post-menopausal women with thumb carpometacarpal osteoarthritis. A randomized trial. J Hand Ther. 2024 Apr-Jun;37(2):172-183. doi: 10.1016/j.jht.2022.07.005. Epub 2022 Aug 7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOL/IREB/25/09/0055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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