NCT06988137

Brief Summary

This study is a prospective, randomized controlled trial evaluating the effectiveness of three conservative treatment approaches-Kinesio taping (KT), buddy taping (BT), and static splinting-for managing finger ligament injuries and non-displaced fractures. A total of 175 patients between the ages of 5 and 60 were randomly assigned to one of the treatment groups and monitored over a 3-month period. The study aims to assess outcomes including range of motion (ROM), grip strength, pain levels, and functional recovery using the QuickDASH questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 14, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

Kinesio tapingBuddy tapingConservative treatmentQuickDASHGrip strengthRange of motionNon-operative hand fractureRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Range of Motion (ROM) in Injured Finger

    Flexion and extension angles of the injured finger joints measured using a digital goniometer. Results expressed in degrees. Higher values indicate better mobility.

    Week 3 and Month 3

Secondary Outcomes (3)

  • QuickDASH Disability Score

    Week 3 and Month 3

  • Grip Strength Recovery

    Month 3

  • Incidence of Skin Complications

    Up to Month 3

Study Arms (3)

Kinesio Taping Group

EXPERIMENTAL

Participants received Kinesio taping using the ligament correction technique with 75-100% elasticity. Immediate active motion was encouraged without immobilization.

Device: Kinesio Taping

Buddy Taping

ACTIVE COMPARATOR

Participants received buddy taping with adjacent finger stabilization and interdigital padding. Mobilization was allowed after 2 weeks.

Procedure: Buddy Taping

Splinting Group

ACTIVE COMPARATOR

Participants were treated with a static volar splint immobilizing the PIP and DIP joints at 20° flexion.

Device: Splinting

Interventions

Elastic therapeutic tape was applied using the ligament correction technique. The tape was reapplied at Day 3 and Day 21 under supervision

Kinesio Taping Group
Buddy TapingPROCEDURE

Buddy taping involved strapping the injured finger to an adjacent digit using medical tape. Early motion was restricted.

Buddy Taping
SplintingDEVICE

A custom-molded thermoplastic splint was applied to restrict joint movement and maintain alignment. Patients remained immobilized until Week 3.

Splinting Group

Eligibility Criteria

Age5 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 5 and 60 years
  • Presentation within 5 days of injury
  • Acute finger ligament sprain or non-displaced finger fracture (PIP or phalangeal)
  • Ability to provide informed consent (or parental consent for minors)
  • Availability for 3-month follow-up

You may not qualify if:

  • Open fractures
  • Polytrauma or systemic injury
  • Delayed presentation (\>5 days post-injury)
  • Need for surgical fixation
  • Previous injury or deformity in the same finger
  • Neurological or rheumatologic disorders affecting hand function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes were assessed by an independent orthopedic surgeon blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of three treatment groups (Kinesio taping, buddy taping, or splinting) and followed for 3 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 23, 2025

Study Start

March 1, 2024

Primary Completion

June 1, 2024

Study Completion

October 15, 2024

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to ethical considerations, lack of specific participant consent for data sharing beyond the study scope, and the absence of a secure data repository. The study was conducted at a single institution and was not originally designed for secondary data use. Future data sharing may be considered upon formal request and appropriate ethical approvals.

Locations