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Carpal Tunnel SyndromeNCT07048379

Different Treatment Approaches for Carpal Tunnel Syndrome

A study testing Orthosis and Physical Therapy in people with Carpal Tunnel Syndrome, run by Sakarya University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Orthosis and Physical Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
No sites listed yet
Study dates
25 Jul 2025to 25 Sep 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Emel TAŞVURAN HORATA, PhD contact

+905547759663

ethorata@gmail.com

About this study

Official title: Comparison of Orthotics, Physical Therapy, and Physical Therapy+Orthotics in Patients With 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.

Read the detailed description

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.

Being tested
Orthosis, Physical Therapy
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrthosisDevice

    Also called 3 weeks

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

  • Physical TherapyOther

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

Study groups in NCT07048379
Study groupRoleWhat they receive
OrthosisExperimentalParticipants will be given a rest orthosis for 3 weeks.
Receives: Device: Orthosis
Physical TherapyExperimentalParticipants 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.
Receives: Other: Physical Therapy
Orthosis+Physical TherapyExperimentalBoth orthotic and physical therapy interventions will be applied for 3 weeks.
Receives: Device: Orthosis; Other: Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2025
  2. Study start25 Jul 2025 (estimated)
  3. Primary completion25 Jul 2025 (estimated)
  4. Study completion25 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07048379
Sponsor's protocol ID
254
Status last verified
Jul 2025
First submitted
24 Jun 2025
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Orthosis and Physical Therapy in people with Carpal Tunnel Syndrome, run by Sakarya University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emel TAŞVURAN HORATA, PhD (+905547759663, ethorata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (visual analogue scale) (time frame: Pain will be assessed before and immediately after the interventions (3 weeks later).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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