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.
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.
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.
- Conditions
- Carpal Tunnel Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| Orthosis | Experimental | Participants will be given a rest orthosis for 3 weeks. Receives: 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. Receives: Other: Physical Therapy |
| Orthosis+Physical Therapy | Experimental | Both 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.
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.
- First posted2 Jul 2025
- Study start25 Jul 2025 (estimated)
- Primary completion25 Jul 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Tasvuran, Sakarya University
- Investigators
- Emel TAŞVURAN HORATA, Principal investigator, Sakarya Applied Sciences UniversityGizem Nur ÇALIŞIR, Study chair, Sakarya Applied Sciences UniversityNimet UÇAROĞLU CAN, Study chair, Sakarya UniversitySinem AKTAŞ, Study chair, Sakarya Applied Sciences UniversityTülay KARSLI, Study chair, Sakarya Applied Sciences UniversityAyşenur Yaren BÜRTEK, Study chair, Sakarya Applied Sciences UniversityEmre Uzun, Study chair, Sakarya University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Orthotics, Physical Therapy, and Physical Therapy+Orthotics in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07048379
- Acronym / sponsor ID
- 254
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 25 Jul 2025 (estimated)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orthosis | Experimental | Device: OrthosisParticipants will be given a rest orthosis for 3 weeks. |
| Physical Therapy | Experimental | Other: Physical TherapyParticipants 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. |
| Orthosis+Physical Therapy | Experimental | Device: Orthosis, Other: Physical TherapyBoth orthotic and physical therapy interventions will be applied for 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be between the ages of 18 and 65
- Have been diagnosed with mild or moderate carpal tunnel syndrome
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrthosisAlso: 3 weeksA resting orthosis will be preferred because it keeps the wrist in a neutral position. | Device | Orthosis, Orthosis+Physical Therapy |
| Physical TherapyParticipants will undergo physical therapy for three weeks, including hot packs, TENS, tendon-nerve sliding exercises, stretching and strengthening exercises. | Other | Orthosis+Physical Therapy, Physical Therapy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emel TAŞVURAN HORATA principal investigator
Sakarya Applied Sciences University
Gizem Nur ÇALIŞIR study chair
Sakarya Applied Sciences University
Nimet UÇAROĞLU CAN study chair
Sakarya University
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.