Bilateral vs. Unilateral Neuromobilization in Carpal Tunnel Syndrome

NCT06554405 | Completed

• 1 other identifier: GaziU-GUNEY-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate whether bilateral (both extremities together) neuromobilization is superior to unilateral (only the affected side) neuromobilization in individuals diagnosed with Carpal Tunnel Syndrome.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Neuromobilization; Median Nerve

Outcome Measures

Primary Outcomes (1)

• Symptom Severity Assessment (Boston Carpal Tunnel Syndrome Questionnaire- Symptom Severity Scale)

  The Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), developed in 1993, will be used to assess individuals' functional status and symptoms. The Turkish validity and reliability study of the test has been conducted. The test consists of two self-assessment sections: one with 11 questions evaluating symptom severity and another with 8 questions evaluating functional capacity. It is a Likert-type questionnaire, where 1 indicates the best condition and 5 indicates the worst condition. The total score is calculated by dividing the total points by the number of questions, resulting in a score between 1 and 5.

  Four weeks

Secondary Outcomes (5)

• Light Touch and Pressure Sense

  Four weeks

• Visual Analog Scale (VAS)

  Four weeks

• Gross Grip Strength

  Four weeks

• Pinch Grip Strength

  Four weeks

• Functional Level Assessment (Boston Carpal Tunnel Syndrome Questionnaire-Functional Status Scale)

  Four weeks

Study Arms (2)

Unilateral Intervention

ACTIVE COMPARATOR

Patients will be treated for 4 weeks (2 days in a week, 8 sessions). The treatment plan involves massage therapy, neuromobilization exercises and cold application. In this arm, treatment plan will be applied only for the symptomatic side. The rest of the treatment will be the same as the other group.

Other: Unilateral Intervention

Bilateral Intervention

EXPERIMENTAL

Patients will be treated for 4 weeks (2 days in a week, 8 sessions). The treatment plan involves massage therapy, neuromobilization exercises and cold application. In this arm, treatment plan will be applied only for both symptomatic and nonsymptomatic sides. The rest of the treatment will be the same as the other group.

Other: Bilateral Intervention

Interventions

Unilateral Intervention OTHER

Treatment plan will be applied to the symptomatic side.

Unilateral Intervention

Bilateral Intervention OTHER

Treatment plan will be applied to the symptomatic and nonsymptomatic sides.

Bilateral Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals diagnosed with CTS,
• Aged 18 and above,
• Without any other conditions in either upper extremity (such as trigger finger, osteoarthritis, tenosynovitis)

You may not qualify if:

• Individuals with a history of surgery, trauma, or fracture in the same upper extremity,
• Those who have received an injection for CTS in the last 3 months,
• Those with poor cooperation,
• Those participating in any other treatment program during the study,
• Those with a history of uncontrolled systemic diseases or systemic diseases involved in the etiology of CTS (such as diabetes, thyroid diseases, rheumatoid arthritis),
• Those who have used orthoses regularly and/or received physiotherapy in the last 3 months,
• Individuals with marked thenar atrophy requiring early surgical intervention

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Sciences

Ankara, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Öznur GÜNEY

  Zonguldak Bulent Ecevit University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher who will evaluate the patients before and after treatment will not know which group the patients are in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Participants will be grouped according to randomization into unilateral or bilateral intervention.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: August 31, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 20, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)