NCT07742293

Brief Summary

This study aims to evaluate the clinical, functional, and ultrasonographic effects of two different kinesiotaping techniques added to a standard exercise and night splint program in the treatment of Carpal Tunnel Syndrome (CTS). Participants will be randomly assigned to one of three groups: the I-Strip kinesiotaping technique group, the Button Hole kinesiotaping technique group, or a control group receiving only standard therapy. The study will assess treatment outcomes over a 12-week period using high-resolution ultrasound (specifically median nerve cross-sectional area and flattening ratio) and clinical parameters to determine the most effective conservative management approach.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress14%
Aug 2026Mar 2027

First Submitted

Initial submission to the registry

July 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

July 25, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

KinesiotapingUltrasonographyMedian NerveExercise Therapy

Outcome Measures

Primary Outcomes (2)

  • Median Nerve Flattening Ratio (FR)

    Measurements will be taken at the pisiform bone level using resolution ultrasound.

    At baseline (T0), 3rd week (T1), and 12th week (T2)

  • Median Nerve Cross-Sectional Area (CSA)

    Using high-resolution ultrasound, measurements will be taken in millimeters square (mm2) at the pisiform bone level.

    At baseline (T0), 3rd week (T1), and 12th week (T2)

Secondary Outcomes (5)

  • Visual Analog Scale (VAS) for Pain (Rest and activity pain intensity, 0-10 cm)

    At baseline (T0), 3rd week (T1), and 12th week (T2)

  • Visual Analog Scale (VAS) for Numbness/Paresthesia (Median nerve trajectory, 0-10 cm)

    At baseline (T0), 3rd week (T1), and 12th week (T2)

  • Boston Carpal Tunnel Questionnaire (BCTQ) for Symptom Severity and Functional Status

    At baseline (T0), 3rd week (T1), and 12th week (T2)

  • Douleur Neuropathique 4 (DN4) Questionnaire Score

    At baseline (T0), 3rd week (T1), and 12th week (T2)

  • Jamar Dynamometer Grip Strength in Kilograms (kg)

    At baseline (T0), 3rd week (T1), and 12th week (T2)

Study Arms (3)

I-Strip Kinesiotaping Group

EXPERIMENTAL

Participants will receive the original I-Strip kinesiotaping technique combined with standard exercise and a night splint program.

Other: I-Strip Kinesiotaping and Standard TherapyOther: Standard Exercise and Splint Therapy

Button Hole Kinesiotaping Group

EXPERIMENTAL

Participants will receive the Button Hole kinesiotaping technique combined with standard exercise and a night splint program.

Other: Button Hole Kinesiotaping and Standard TherapyOther: Standard Exercise and Splint Therapy

Control Group

ACTIVE COMPARATOR

Participants will only receive a standard exercise and overnight splint program.

Other: Standard Exercise and Splint Therapy

Interventions

Application of the original I-Strip kinesiotaping technique combined with a standard program of tendon/nerve gliding exercises and a night splint for 12 weeks.

I-Strip Kinesiotaping Group

Application of the Button Hole kinesiotaping technique combined with a standard program of tendon/nerve gliding exercises and a night splint for 12 weeks.

Button Hole Kinesiotaping Group

Twelve weeks of tendon/nerve gliding exercises and night splinting.

Button Hole Kinesiotaping GroupControl GroupI-Strip Kinesiotaping Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being aged between 18 and 65 years.
  • Willingness and ability to sign the informed consent form.
  • Having symptoms of carpal tunnel syndrome (hand numbness, tingling, pain) for at least 3 months.
  • Clinical diagnosis of mild-to-moderate carpal tunnel syndrome confirmed by physical examination (positive Phalen/Tinel tests) and a prior nerve conduction study (EMG).

You may not qualify if:

  • Previous wrist or hand surgery.
  • Severe carpal tunnel syndrome on EMG (evidence of thenar atrophy or severe motor loss).
  • History of trauma, fracture in the wrist area, or anatomical anomalies affecting ultrasonography.
  • Cervical radiculopathy, polyneuropathy, diabetic neuropathy, or other concomitant upper extremity entrapment neuropathies.
  • Local corticosteroid injection to the carpal tunnel within the last 6 months.
  • Pregnancy.
  • Systemic corticosteroid use or inflammatory rheumatic diseases.
  • Cognitive impairment or psychiatric illness preventing comprehension of questionnaire instructions.
  • Lack of a prior EMG report upon admission to the outpatient clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Furkan Erdinc, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 25, 2026

First Posted

August 3, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 7, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified participant data underlying the results reported in the published article will be shared upon reasonable request directed to the corresponding author, starting from publication and ending 3 years following article publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning from the date of publication and extending for 3 years.
Access Criteria
Researchers who provide a scientifically sound proposal and whose proposed use of data has been approved by the principal investigator. Requests can be directed to the corresponding author via email.