- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07567248
The Effect of Kinesio Taping on Hand Functions in Zone V-VI Extensor Tendon Injuries
Investigation of the Effect of Kinesio Taping on Hand Functions in Zone V-VI Extensor Tendon Injuries: A Double-Blind Randomized Controlled Clinical Trial
This study aims to investigate the effects of Kinesio Taping (KT) on hand function in patients with Zone V-VI Extensor Digitorum Communis (EDC) tendon injuries following primary repair. Extensor tendon injuries in this region often lead to complications such as adhesion formation, reduced range of motion, extensor lag, and impaired hand function, despite standard rehabilitation approaches. Therefore, additional interventions that may enhance tendon gliding and neuromuscular control are of clinical interest.
In this double-blind randomized controlled trial, patients will be assigned to either a KT group or a sham taping control group. Both groups will receive a standardized postoperative rehabilitation program, while the intervention group will additionally receive KT applications between postoperative weeks 6 and 12. Outcome measures, including range of motion, grip and pinch strength, and functional hand performance, will be assessed at 12 and 24 weeks.
The study seeks to determine whether KT provides additional benefits beyond conventional rehabilitation in improving functional recovery after extensor tendon injuries, addressing an important gap in the current literature.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: HANDE USTA OZDEMIR, PhD
- Phone Number: +902582964279
- Email: husta@pau.edu.tr
Study Locations
-
-
Kınıklı
-
Denizli, Kınıklı, Turkey (Türkiye), 20070
- Pamukkale University
-
Contact:
- HANDE USTA OZDEMIR, PhD
- Phone Number: +902582964279
- Email: husta@pau.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18 and 65 years
- Having an isolated Zone V-VI extensor tendon injury
- Having undergone primary treatment for the injury
Exclusion Criteria:
- History of prior surgery on the affected extremity
- Presence of accompanying neurological, orthopedic, rheumatologic, or metabolic disease in the affected extremity
- Presence of flexor tendon injury
- Presence of fractures of the metacarpals, carpal bones, or radius/ulna
- Presence of an open incision line
- Delayed wound healing
- Presence of peripheral nerve injury
- Presence of replantation or amputation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients in the kinesio taping group
Patients in the kinesio taping group will receive KT application starting at postoperative week 6, after complete discontinuation of splint immobilization.
During application, the functional correction technique will be used from the insertion to the origin of the Extensor Digitorum Communis (EDC) muscle, with approximately 25-50% tension applied to the tape.
KT applications will be performed twice weekly between postoperative weeks 6 and 12, using three tapes in each session.
New tapes will be applied in each session and replaced no later than 3 days after the previous application.
Before each taping session, the application area will be properly cleaned.
Additionally, patients and their caregivers will be thoroughly informed about hygiene of the application area and proper tape removal.
The button-hole technique and I-strip technique will be used.
|
Button-Hole Technique (Affected finger(s)) I-Strip Technique (Support for all metacarpal bones) Supportive Tape Application
|
|
Sham Comparator: Patients in the control group
Patients in the control group will receive sham taping.
The application will begin at postoperative week 6 after complete discontinuation of splint immobilization.
In the sham application, all steps of the KT procedure (cutting, placement, and application process) will be mimicked; however, no therapeutic tension will be applied to the tapes.
Sham taping will be applied twice weekly between postoperative weeks 6 and 12, using three tapes per session.
New tapes will be applied in each session and replaced no later than 3 days after the previous application.
Before each application, the taping area will be properly cleaned.
Patients and their caregivers will also be thoroughly informed about hygiene and proper tape removal.
|
Sham Button-Hole Technique (Affected finger(s)) Sham I-Strip Technique (Support for all metacarpal bones) Sham Supportive Tape Application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Finger ROM Measurement
Time Frame: Post operative at 12 and 24 weeks
|
With the wrist in a neutral position, active flexion and extension movements of the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints will be measured using a metal finger goniometer.
|
Post operative at 12 and 24 weeks
|
|
Assessment of Gross Grip and Pinch Strength
Time Frame: Post operative at 12 and 24 weeks
|
Gross grip strength will be measured using a hand dynamometer, and pinch strength will be measured in four different positions (tip, pulp, lateral, and three-point pinch) using a pinch meter (Jamar® Hydraulic Dynamometer-Pinchmeter, Serial No: 1420513), according to the standard measurement protocol of the American Society of Hand Therapists.
|
Post operative at 12 and 24 weeks
|
|
Michigan Hand Outcomes Questionnaire
Time Frame: Post operative at 12 and 24 weeks
|
The MHQ was developed to measure health status in patients with hand deformities and assesses how well patients perform their usual activities.
Each question is scored on a 5-point Likert scale.
The total score is calculated by summing all domain scores and dividing by six.
Higher scores indicate better outcomes.
The questionnaire will be administered by the researchers through face-to-face interviews using a question-and-answer format
|
Post operative at 12 and 24 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kodak MIH, Özüdoğru A, Basat HÇ, Tuncay F. Early effects of Kinesio taping on clinical outcomes in patients with arthroscopic rotator cuff repair: a double-blind randomized controlled trial. Sports Health. 2025. doi:10.1177/19417381251397956.
- Horoz L, Cigdem-Karacay B, Cakmak MF. Effect of Kinesio taping on edema and wrist functions in patients with distal radius fracture treated conservatively with a cast: a randomized controlled single-blinded study. J Hand Ther. 2024;37(3):479-488. doi:10.1016/j.jht.2024.05.003.
Study record dates
Study Major Dates
Study Start (Estimated)
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
- E-60116787-020-859084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tendon Injuries
-
Zimmer BiometEmbody Inc.Active, not recruiting
-
Aarhus University HospitalEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon InjuryDenmark
-
Vastra Gotaland RegionCapio Group; ATLEVA FotcenterRecruitingTendon Injuries | Surgery | Tendon Rupture | Tendon TearSweden
-
Aristotle University Of ThessalonikiGeneral Hospital of Naoussa; Private Orthopedics Practice P. SymeonidisEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon Injury | Achilles Tendon SurgeryGreece
-
University of ZurichCompleted
-
Fundació Institut de Recerca de l'Hospital de la...Recruiting
-
Research SourceEnrolling by invitation
-
Sahlgrenska University Hospital, SwedenCompletedTendon Injury - HandSweden
-
University of FloridaRecruitingProspective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon InjuriesFlexor TendonUnited States
-
Cairo UniversityRecruitingHand Tendon InjuryEgypt
Clinical Trials on Kinesio Taping
-
University of BeykentRecruiting
-
Norwegian School of Sport SciencesCompletedMuscle Weakness | Anterior Knee Pain | Knee SymptomsNorway
-
Istinye UniversityNot yet recruitingHealthy Volunteers | Motor Performance | Upper Extremity Function | Perceived FunctionTurkey (Türkiye)
-
Universidade Federal de PernambucoCompleted
-
Istanbul Medipol University HospitalCompleted
-
Istinye UniversityCompleted
-
Cardenal Herrera UniversityCompletedMobility Limitation | Myofascial Trigger Point PainSpain
-
Cardenal Herrera UniversityCompletedMobility Limitation | Myofascial Trigger Point Pain
-
Ataturk Training and Research HospitalUnknown
-
Kübra SarıoğluRecruitingSubacromial Impingement Syndrome | Shoulder PainTurkey (Türkiye)