- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: HANDE USTA OZDEMIR, PhD
- Telefonnummer: +902582964279
- E-post: husta@pau.edu.tr
Studiesteder
-
-
Kınıklı
-
Denizli, Kınıklı, Tyrkia (Türkiye), 20070
- Pamukkale University
-
Ta kontakt med:
- HANDE USTA OZDEMIR, PhD
- Telefonnummer: +902582964279
- E-post: husta@pau.edu.tr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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
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Sham-komparator: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Finger ROM Measurement
Tidsramme: 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.
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Post operative at 12 and 24 weeks
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Assessment of Gross Grip and Pinch Strength
Tidsramme: 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.
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Post operative at 12 and 24 weeks
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Michigan Hand Outcomes Questionnaire
Tidsramme: Post operative at 12 and 24 weeks
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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
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Post operative at 12 and 24 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E-60116787-020-859084
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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