Different Treatment Approaches for Carpal Tunnel Syndrome

NCT07048379 | Not Yet Recruiting

• 1 other identifier: 254
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

Carpal tunnel syndrome is a common syndrome in the upper extremities resulting from compression of the median nerve, which branches out to the first three fingers of the wrist. The project will be studied in three separate groups. The first group consists of patients who only use orthoses, the second group consists of patients who only receive physical therapy, and the third group consists of patients who receive both orthoses and physical therapy. The aim of all three groups is to examine the effects of the interventions on the daily living activities, pain, grip strength, and quality of life of patients with carpal tunnel syndrome and to evaluate the patients' satisfaction levels after the interventions. As part of the study, the group using orthoses will be given a resting orthosis that keeps the wrist in a neutral position. The group receiving physical therapy will be administered Transcutaneous Electrical Nerve Stimulation (TENS) current, hot packs, and exercises. The third group will receive both the orthosis approach and the physical therapy approach. Ultimately, this project aims to help determine the most beneficial intervention for patients with carpal tunnel syndrome by comparing these three interventions.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Pain (visual analogue scale)

  Pain will be assessed using a visual analogue scale. "Zero point" means that there is no pain and "Ten point" is unbearable pain according to scale.

  Pain will be assessed before and immediately after the interventions (3 weeks later).

Study Arms (3)

Orthosis

EXPERIMENTAL

Participants will be given a rest orthosis for 3 weeks.

Device: Orthosis

Physical Therapy

EXPERIMENTAL

Participants will receive physical therapy treatment for 3 weeks (15 sessions). Each physical therapy session will consist of hot packs and TENS applications, tendon-nerve sliding exercises, stretching and strengthening exercises.

Other: Physical Therapy

Orthosis+Physical Therapy

EXPERIMENTAL

Both orthotic and physical therapy interventions will be applied for 3 weeks.

Device: Orthosis; Other: Physical Therapy

Interventions

Orthosis DEVICE

A resting orthosis will be preferred because it keeps the wrist in a neutral position.

Also known as: 3 weeks

Orthosis; Orthosis+Physical Therapy

Physical Therapy OTHER

Participants will undergo physical therapy for three weeks, including hot packs, TENS, tendon-nerve sliding exercises, stretching and strengthening exercises.

Orthosis+Physical Therapy; Physical Therapy

Eligibility Criteria

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

You may qualify if:

• Be between the ages of 18 and 65
• Have been diagnosed with mild or moderate carpal tunnel syndrome

You may not qualify if:

• Symptom duration of more than 12 months,
• Those who have undergone surgery for carpal tunnel syndrome
• Those who have received physical therapy within the last 6 months,
• Those who have received steroid injections into the carpal tunnel,
• Those with a history of trauma to the wrist and surrounding area,
• Those using non-steroidal anti-inflammatory drugs,
• Individuals with additional systemic, musculoskeletal, or neurological conditions that may affect symptoms will be excluded from the study.

Sponsors & Collaborators

• Sakarya University: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Orthotic Devices; Physical Therapy Modalities

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

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Therapeutics; Rehabilitation

Study Officials

• Emel TAŞVURAN HORATA

  Sakarya University of Applied Sciences

  PRINCIPAL INVESTIGATOR

• Gizem Nur ÇALIŞIR

  Sakarya University of Applied Sciences

  STUDY CHAIR

• Nimet UÇAROĞLU CAN

  Sakarya University

  STUDY CHAIR

• Sinem AKTAŞ

  Sakarya University of Applied Sciences

  STUDY CHAIR

• Tülay KARSLI

  Sakarya University of Applied Sciences

  STUDY CHAIR

• Ayşenur Yaren BÜRTEK

  Sakarya University of Applied Sciences

  STUDY CHAIR

• Emre Uzun

  Sakarya University

  STUDY CHAIR

Central Study Contacts

Emel TAŞVURAN HORATA, PhD

CONTACT

+905547759663; ethorata@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD; Associate Professor

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 25, 2025
• Primary Completion: July 25, 2025
• Study Completion: September 25, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share