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NCT Number: NCT07048379

Different Treatment Approaches for Carpal Tunnel Syndrome

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.

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Key information

About this study

Carpal tunnel syndrome is a peripheral neuropathy caused by compression of the median nerve in the wrist. It is a syndrome that is commonly seen in approximately 1-5% of the population throughout their lifetime. It is more common in middle-aged women. Conservative treatment is generally preferred for mild to moderate carpal tunnel syndrome. Conservative treatment allows for the reduction or even elimination of symptoms associated with this syndrome without the need for surgery. Individuals can continue their daily lives as usual. The use of orthoses, one of these methods, plays an important role in the treatment of carpal tunnel syndrome. Orthotics minimise movement of the wrist, preventing compression in this area, contributing to functional improvement and benefiting the individual's daily activities. Using orthotics throughout the day can have a positive effect on the individual's condition by reducing and preventing inflammation of the median nerve. Another conservative treatment approach is physical therapy. In physical therapy, exercises to strengthen the wrist muscles, stretching exercises to increase joint range of motion, and hot-cold applications in people with carpal tunnel syndrome are also effective in reducing pain. Additionally, there are patients who use orthoses and undergo physical therapy. When comparing the treatment periods of this group of patients to the other two groups, it is believed that their recovery periods will be shorter and they will recover more quickly than with the other two approaches. This study's aim is investigating the effects of the three intervention approaches on patients' quality of life, daily living activities, reduction in pain intensity, and grip strength, taking patient satisfaction into account. The project will be examined across three separate groups. The first group consists of patients who use only orthoses, the second group consists of patients who receive only 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Orthosis

Device

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

Other names: 3 weeks

Physical Therapy

Other

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

Primary outcomes

  1. Pain (visual analogue scale)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emel TAŞVURAN HORATA, PhD

CONTACT

[email protected]

+905547759663

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

Comparison of Orthotics, Physical Therapy, and Physical Therapy+Orthotics in Patients With Carpal Tunnel Syndrome

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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