NCT06882707

Brief Summary

This randomized, clinical, single-blinded, controlled study will initially planned to include 86 patients diagnosed with carpal tunnel syndrome who applied to Kütahya Health Sciences University, Evliya Çelebi Training and Research Hospital, Physical Medicine and Rehabilitation outpatient clinic and Kutahya City Hospital.Patients aged 20-55 years who were diagnosed with mild and moderate carpal tunnel syndrome by electromyography (EMG) in the last 6 months were included in the study. The patients were randomized into two groups using the computer-assisted randomization method. Median nerve mobilization and ultrasound therapy will be given to the study group, and only ultrasound therapy will be given to the control group. All the patients were evaluated with the Visual Analog Scale (VAS), Hand and Pinching Grip Test, Boston Carpal Tunnel Questionnaire (BCTQ) and Median Nerve and Abductor Pollicis Brevis Muscle ultrasonography before the intervention and at the third week of intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

March 12, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

carpal tunnel syndromemedian nerve mobilizationabductor pollicis brevisboston carpal tunnel questionnairehand gripultrasonography

Outcome Measures

Primary Outcomes (1)

  • Ultrasound assessment

    The Median nerve's diameter will be evaluated bilaterally by another researcher blinded to interventions and experienced in musculoskeletal ultrasonography, using ultrasound with a 6-18 Mhz linear probe (Mindray-UMT 200, USA). During the examination, patients will be seated on a stretcher, while the examiner sat on a higher stool. The Median nerve will be evaluated by measuring the circumference of the nerve at the location where the nerve entered the carpal tunnel. The ultrasound probe will be positioned above the epicondylus lateralis. The nerve cross-sectional area (CSA) will be recorded in the carpal tunnel while it was perpendicular to the wrist at 90 degrees on the Median nerve trace. The nerve diameter will be measured from the circumference of the epineurium.

    Change from Baseline at 3th weeks

Secondary Outcomes (2)

  • Hand and pinching grip measurement

    Change from Baseline at 3th weeks

  • Symptom severity and functional status

    Change from Baseline at 3th weeks

Study Arms (2)

Median nerve mobilization in addition to ultrasound therapy

EXPERIMENTAL

In addition nerve mobilization, ultrasound therapy will be applied to all patient in experimental group via methods explained below.

Other: Median Nerve MobilizationOther: Ultrasound therapy

Ultrasound therapy

ACTIVE COMPARATOR

In control group, patients will received only ultrasound therapy.

Other: Ultrasound therapy

Interventions

Passive neuromobilisation of the median nerve and functional self-exercises. The procedure started with the patient in the supine position. The following steps were taken in sequence: shoulder girdle depression; slight abduction of the elbow extension with arm lateral rotation and forearm supination; wrist, finger and thumb extensions were added; and the shoulder was taken into further extension. To apply maximum stretch opposite cervical side flexion was done, and, in the end, the wrist was repeatedly moved into and out of stretch by performing a few degrees of flexion and extension at the wrist. This mobilization technique will be performed by an experienced physician/physiotherapist three times a week for 3 weeks, and the patients will be given 3 sets of 15 cycles with a 1-minute rest period in each set.

Median nerve mobilization in addition to ultrasound therapy

In control group, patients will received only ultrasound therapy. The patient will be in a sitting position with his/her face facing the physiotherapy technician, elbow in 90 degree flexion, forearm in supination, wrist in neutral position and supported by placing a towel under the patient's extremity and will be applied in Us intermittent mode with an intensity of 0.8 W/cm2 in 1 MHZ frequency in 1:4 mode for 10 minutes, moving in a way to draw an infinity sign for 10 seconds. Treatment will be given 5 days a week for 3 weeks and a total of 15 sessions.

Median nerve mobilization in addition to ultrasound therapyUltrasound therapy

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with mild-to-moderate CTS on the dominant hand, based on the electrodiagnostic examination.
  • Aged 20-55 years.
  • Consent to receive the described treatment.
  • Lasting symptoms at least 3 months

You may not qualify if:

  • A systemic inflammatory disease.
  • Any disease that can cause polyneuropathy, for example, diabetes mellitus.
  • A cognitive disorder.
  • Receiving psychotherapy.
  • A pacemaker.
  • Any disease that can affect the central nervous system.
  • Carpal tunnel syndrome surgery history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Turkey, 43050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeutics

Study Officials

  • Merve Akdeniz LEBLEBİCİER, MD

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 18, 2025

Study Start

March 15, 2025

Primary Completion

June 15, 2025

Study Completion

August 15, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations