NCT07359274

Brief Summary

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy caused by compression of the median nerve at the wrist. Conservative interventions such as splinting and manual therapy are frequently used in individuals with mild-to-moderate CTS. Neurodynamic mobilization and carpal bone mobilization aim to improve neural and soft tissue mobility; however, their comparative effects on clinical outcomes and median nerve morphology are not fully understood. This interventional, non-randomized clinical study aims to compare the clinical and ultrasonographic effects of neurodynamic mobilization plus splinting, carpal bone mobilization plus splinting, and splinting alone in patients with mild-to-moderate CTS. Ninety-three participants diagnosed with mild-to-moderate carpal tunnel syndrome based on electrodiagnostic criteria will be included. Participants will be allocated into three parallel groups without randomization. All participants will receive a neutral-position wrist splint as standard conservative care. Two intervention groups will additionally receive either neurodynamic mobilization exercises or carpal bone mobilization techniques administered by a physiotherapist for four weeks. Clinical outcomes and median nerve morphology will be evaluated at baseline and immediately after the intervention period. The primary outcome is the change in the Boston Carpal Tunnel Questionnaire score. Secondary outcomes include pain intensity, neuropathic pain, functional disability, muscle strength, pressure pain threshold, and ultrasonographic measurements of the median nerve.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

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 Progress27%
Jan 2026Mar 2027

First Submitted

Initial submission to the registry

January 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 13, 2026

Last Update Submit

January 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Boston Carpal Tunnel Questionnaire (BCTQ) Total Score

    Change in Boston Carpal Tunnel Questionnaire (BCTQ) Total Score

    Baseline to 4 weeks

Secondary Outcomes (7)

  • Visual Analog Scale (VAS)

    Baseline to 4 weeks

  • Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)

    Baseline to 4 weeks

  • Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)

    Baseline to 4 weeks

  • Grip Strength

    Baseline to 4 weeks

  • Pinch Strength

    Baseline to 4 weeks

  • +2 more secondary outcomes

Study Arms (3)

neurodynamic mobs in addition splint

EXPERIMENTAL

Median nerve neurodynamic mobilization exercises administered by a physiotherapist for 4 weeks in addition to night-time wrist splint use

Other: Neurodynamic mobilizationOther: Splint

Carpal Bone Mobilization + Splint

EXPERIMENTAL

Carpal bone mobilization techniques administered by a physiotherapist for 4 weeks in addition to night-time wrist splint use.

Other: Carpal bone mobilizationOther: Splint

Splint only

ACTIVE COMPARATOR

Neutral-position wrist splint worn at night for 4 weeks.

Other: Splint

Interventions

Median nerve neurodynamic mobilization exercises performed 5 sessions per week for 4 weeks.

neurodynamic mobs in addition splint

Manual carpal bone mobilization techniques applied 5 sessions per week for 4 weeks.

Carpal Bone Mobilization + Splint
SplintOTHER

Neutral-position wrist splint used during night-time for 4 weeks.

Carpal Bone Mobilization + SplintSplint onlyneurodynamic mobs in addition splint

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of mild-to-moderate carpal tunnel syndrome confirmed by electrodiagnostic testing
  • CTS symptoms for at least 3 months
  • Ability to provide informed consent

You may not qualify if:

  • Previous carpal tunnel surgery
  • Diabetes mellitus or polyneuropathy
  • Cervical radiculopathy
  • Pregnancy or breastfeeding
  • Central nervous system disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University Yoncalı Physical Therapy and Rehabilitation Hospital

Kütahya, Yoncalı, 43000, Turkey (Türkiye)

Location

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 Officials

  • Merve Akdeniz Leblebicier, MD

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Akdeniz Leblebicier, MD

CONTACT

Esengül Alıcı, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 22, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

March 15, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations