NCT06514625

Brief Summary

The effect of conservative treatments on sleep quality in carpal tunnel syndrome is unclear. Comparing the effect of splinting and kinesiotaping in carpal tunnel syndrome on functional status, pain, grip strength, nerve cross-sectional area and sleep quality. Participants were divided into 3 groups. One group received night splint and nerve tendon gliding exercises, one group received kinesiotaping and nerve tendon gliding exercises, and one group received only nerve tendon gliding exercises. Participants were evaluated by a blinded investigator at baseline and at 3 months by Visual Analogue Scale (VAS), Boston Carpal Tunnel Syndrome Questionnaire, Pittsburgh Sleep Quality Index (PSQI), Jamar hand dynamometer and ultrasonography.

Trial Health

87
On Track

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
Completed

Started Nov 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 8, 2024

Last Update Submit

July 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • sleep quality

    Evaluated with "The Pittsburgh Sleep Quality Index ".

    at baseline and third month

  • median nerve cross-sectional area

    Measured at the wrist by ultrasonography.

    at baseline and third month

Study Arms (3)

splint and exercise

EXPERIMENTAL

The patient was asked to wear the fabricated splint that fixes the wrist in the neutral position every night and during the day as much as possible

Device: splint

kinesiotaping and exercise

EXPERIMENTAL

Kinesiotaping was applied twice a week for a total of 8 sessions for 4 weeks. Taping was performed with a "neural technique" for the median and "field correction technique" for releasing the carpal tunnel. The elbow was positioned in full extension, the forearm in supination, and the wrist in 30 extension. I tape was used for neural technique. Tape was applied to the skin along the median nerve from the second and third metacarpophalangeal joints to five centimetres distal to the medial epicondyle. For the area correction technique, the I tape, which is half of the wrist circumference, was heavily stretched to the volar side of the wrist and the middle 1/3 part was taped without stretching the edges.

Device: splint

exercise

ACTIVE COMPARATOR

Nerve tendon gliding exercises were taught practically by an experienced physiotherapist. Participants were asked to do three sets of 10 repetitions every day for one month. Tendon gliding exercises were performed by bringing the hand into five different positions: regular grip, hook grip, punch, tabletop, and regular punch. Nerve gliding exercises were performed by bringing the fingers and wrist into six different positions: fingers and thumb in flexion with the wrist in neutral position, fingers and thumb in extension with the wrist in neutral position, thumb in neutral position with the wrist and fingers in extension, wrist, fingers, and thumb in extension, forearm in supination, and gentle stretching of the thumb with the other hand. Patients were given a thirty day exercise diary.

Device: splint

Interventions

splintDEVICE

ready night splints

exercisekinesiotaping and exercisesplint and exercise

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed with mild and moderate carpal tunnel syndrome with nerve conduction velocity study
  • To be between the ages of 18-65

You may not qualify if:

  • Inflammatory disease (rheumatoid arthritis, tendinitis, etc.),
  • Osteoarthritis in the hand/wrist,
  • Musculoskeletal conditions (hand, elbow, wrist),
  • Thyroid disease
  • Chronic kidney failure
  • Carpal tunnel syndrome surgery,
  • History of surgery and/or trauma to the upper extremity and neck.
  • Pregnancy or diabetes-related carpal tunnel syndrome,
  • Receiving any treatment for carpal tunnel syndrome (splint therapy, electrophysical agents, exercise, local corticosteroid injection) up to 3 months prior to the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Beyhekim Research and Training Hospital

Konya, Selçuklu, 42060, Turkey (Türkiye)

Location

Related Publications (1)

  • Karpuz S, Yilmaz R, Ozkan M, Kaya IC, Bulut O, Erol K, Yilmaz H. Effect of splinting and kinesiotaping treatments on functional status, sleep quality and median nerve cross-sectional area in carpal tunnel syndrome: A single blind prospective randomized controlled study. J Hand Ther. 2025 Jul-Sep;38(3):483-491. doi: 10.1016/j.jht.2024.12.001. Epub 2025 Jan 6.

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Splints

Condition Hierarchy (Ancestors)

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

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
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 23, 2024

Study Start

November 1, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations