Carpal Tunnel Syndrome (CTS)NCT07417722
Effects of Peloid Therapy in Patients With Carpal Tunnel Syndrome
A study testing Peloid Therapy, Wrist Splint and Home Exercise Program in people with Carpal Tunnel Syndrome (CTS), run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Carpal tunnel syndrome is a common condition caused by pressure on a nerve at the wrist. It can lead to pain, numbness, weakness, and difficulty using the hand during daily activities. In this clinical trial, researchers will study a non-drug treatment approach for people with carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Peloid Therapy, Wrist Splint and Home Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild or mild-to-moderate carpal tunnel syndrome confirmed by electromyography (EMG)
- Presence of clinical symptoms for at least 3 months
- Age 18 years and older
- No limitation in wrist joint range of motion
Who cannot join
- Cervical radiculopathy
- Polyneuropathy
- Pregnancy
- Presence of underlying metabolic diseases (diabetes mellitus, inflammatory rheumatic diseases, thyroid disorders)
- Presence of hand osteoarthritis
- Previous wrist or hand surgery
Show all 12Show fewer
- Severe carpal tunnel syndrome confirmed by electromyography (EMG)
- Thenar muscle atrophy
- Corticosteroid injection for carpal tunnel syndrome or use of a wrist splint within the last 6 months
- History of malignancy
- Receipt of peloid therapy or any physical therapy modality for carpal tunnel syndrome within the last 6 months
- Contraindications to peloid therapy (impaired skin integrity or active infection at the application site)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Training and Research Hospital
Istanbul
About this study
Official title: Investigation of the Effects of Peloidotherapy on Pain Severity, Functional Status, and Ultrasonographic Findings in Patients With Carpal Tunnel Syndrome: A Randomized, Prospective, Single-Blind Study
Carpal tunnel syndrome is a common condition caused by pressure on a nerve at the wrist. It can lead to pain, numbness, weakness, and difficulty using the hand during daily activities.
In this clinical trial, researchers will study a non-drug treatment approach for people with carpal tunnel syndrome. Participants will be randomly assigned to one of two groups. One group will receive a wrist splint and a home exercise program. The other group will receive peloidotherapy in addition to the same splint and exercise program.
Read more
Pain, hand function, daily activities, quality of life, hand strength, and ultrasound findings of the median nerve will be evaluated before treatment, at the end of treatment, and during follow-up periods.
The goal of this study is to determine whether adding peloidotherapy to wrist splint and a home exercise program provides additional benefits in reducing pain and improving hand function in people with carpal tunnel syndrome.
Read the detailed description
Carpal tunnel syndrome is a common compressive neuropathy caused by entrapment of the median nerve at the wrist. It is characterized by pain, numbness, paresthesia, weakness, and functional limitations of the hand, which may negatively affect daily activities and quality of life. Conservative treatment approaches are frequently preferred, particularly in mild to moderate cases, and include wrist splinting, exercise programs, and physical therapy modalities.
This randomized, prospective, single-blind clinical trial was conducted to investigate the effects of peloidotherapy as an adjunct to wrist splint and a home exercise program in individuals with carpal tunnel syndrome. Eligible participants diagnosed with carpal tunnel syndrome were randomly assigned to one of two treatment groups.
The control group received a wrist splint and a structured home exercise program. The intervention group received peloidotherapy in addition to the same wrist splint and home exercise program. Peloidotherapy was applied in standardized 15 sessions under controlled conditions throughout the treatment period.
Clinical and functional assessments were performed at four time points: at baseline before treatment (week 0), at the end of the treatment period (week 3), and during follow-up at one month (week 7) and three months (week 15) after completion of treatment. This assessment schedule was designed to evaluate both short-term and sustained effects of the interventions.
Outcome measures included pain intensity, functional status of the hand, functional disability, quality of life, hand grip strength, neuropathic pain characteristics, and ultrasonographic evaluation of the median nerve, including measurements of the nerve cross-sectional area.
The primary objective of this study was to determine whether the addition of peloidotherapy to wrist splint and a home exercise program provides additional benefits in reducing pain and improving hand function in individuals with carpal tunnel syndrome. Secondary objectives included the evaluation of changes in quality of life, hand grip strength, neuropathic pain features, and ultrasonographic findings during follow-up.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Peloid Therapy, Wrist Splint, Home Exercise Program
- Keywords
- Carpal Tunnel Syndrome, Peloidotherapy, Median Nerve Cross-Sectional Area, Hand Grip Strength, Functional Disability, Pain
- Medical subject headings
- Carpal Tunnel Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peloid TherapyOther
Peloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions.
Wrist SplintDevice
Participants used a neutral-position wrist splint as part of conservative treatment for carpal tunnel syndrome.
Home Exercise ProgramOther
Participants performed a standardized home exercise program including median nerve gliding exercises and tendon gliding exercises for the wrist and hand.
| Study group | Role | What they receive |
|---|---|---|
| Non-Peloid Therapy Group | Active comparator | Participants receive treatment consisting of wrist splinting and a structured home exercise program. No peloid therapy is administered. Receives: Device: Wrist Splint; Other: Home Exercise Program |
| Peloid Therapy Group | Experimental | Participants receive wrist splinting and a structured home exercise program in addition to peloid therapy. Peloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions. Receives: Other: Peloid Therapy; Device: Wrist Splint; Other: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Questionnaire (BCTQ)
Symptom severity and functional status measured using the Boston Carpal Tunnel Questionnaire (BCTQ), which includes Symptom Severity and Functional Status subscales. Each item is scored from 1 to 5 and subscale scores are calculated as the mean of item scores. Higher scores indicate worse symptoms and functional limitation.
Measured: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Secondary outcomes (5)
Median Nerve Cross-Sectional Area
Median nerve cross-sectional area was measured using ultrasonography.
Measured: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), and 3-month follow-up (week 15).
QuickDASH Score
Upper extremity disability measured using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.
Measured: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Visual Analog Scale for Pain at Rest
Pain intensity at rest measured using the Visual Analog Scale (VAS), scored from 0 to 10. Higher scores indicate worse pain.
Measured: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Visual Analog Scale for Pain During Activity
Pain intensity during activity measured using the Visual Analog Scale (VAS), scored from 0 to 10. Higher scores indicate worse pain.
Measured: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Visual Analog Scale for Night Pain
Night pain intensity measured using the Visual Analog Scale (VAS), scored from 0 to 10. Higher scores indicate worse pain.
Measured: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Jun 2025
- Primary completion11 Sep 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- 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
- Model description
- Participants were randomly assigned to one of two parallel groups. One group received a wrist splint and a home exercise program, while the other group received peloidotherapy in addition to the same wrist splint and home exercise program. Participants remained in their assigned group throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İrem Çiftler Gayret., Gaziosmanpasa Research and Education Hospital
- Investigators
- Ebru Yılmaz Yalçınkaya, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, Gaziosmanpaşa Training and Research Hospital, Istanbul, TurkeySerap Seringeç Karabulut, MD, Principal investigator, Department of Medical Ecology and Hydroclimatology, Gaziosmanpaşa Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417722
- Sponsor's protocol ID
- 515
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and legal restrictions related to patient confidentiality and institutional policies.
Publications
Tezcan S, Ulu Ozturk F, Uslu N, Nalbant M, Umit Yemisci O. Carpal Tunnel Syndrome: Evaluation of the Effects of Low-Level Laser Therapy With Ultrasound Strain Imaging. J Ultrasound Med. 2019 Jan;38(1):113-122. doi: 10.1002/jum.14669. Epub 2018 Jun 11.
PubMed 29892976Yigit F, Ordahan B. Effects of high-intensity laser therapy on pain, functional status, hand grip strength, and median nerve cross-sectional area by ultrasonography in patients with carpal tunnel syndrome. Lasers Med Sci. 2023 Oct 31;38(1):248. doi: 10.1007/s10103-023-03913-z.
PubMed 37906312Metin Okmen B, Kasapoglu Aksoy M, Gunes A, Eroksuz R, Altan L. Effectiveness of PELOID therapy in carpal tunnel syndrome: A randomized controlled single blind study. Int J Biometeorol. 2017 Aug;61(8):1403-1410. doi: 10.1007/s00484-017-1317-1. Epub 2017 Feb 16.
PubMed 28210859Sirin Ahisha B, Akkaya Ari S, Paker N, Kesiktas N, Barut Y. Comparison of the efficacy of peloid therapy and paraffin treatment in carpal tunnel syndrome. Int J Biometeorol. 2025 Aug;69(8):1957-1967. doi: 10.1007/s00484-025-02941-4. Epub 2025 May 13.
PubMed 40358708
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Peloidotherapy on Pain Severity, Functional Status, and Ultrasonographic Findings in Patients With Carpal Tunnel Syndrome: A Randomized, Prospective, Single-Blind Study
- ClinicalTrials.gov ID
- NCT07417722
- Acronym / sponsor ID
- 515
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Carpal Tunnel Syndrome, Peloidotherapy, Median Nerve Cross-Sectional Area, Hand Grip Strength, Functional Disability, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 18 Feb 2026 (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 condition caused by pressure on a nerve at the wrist. It can lead to pain, numbness, weakness, and difficulty using the hand during daily activities.
In this clinical trial, researchers will study a non-drug treatment approach for people with carpal tunnel syndrome. Participants will be randomly assigned to one of two groups. One group will receive a wrist splint and a home exercise program. The other group will receive peloidotherapy in addition to the same splint and exercise program.
Pain, hand function, daily activities, quality of life, hand strength, and ultrasound findings of the median nerve will be evaluated before treatment, at the end of treatment, and during follow-up periods.
The goal of this study is to determine whether adding peloidotherapy to wrist splint and a home exercise program provides additional benefits in reducing pain and improving hand function in people with carpal tunnel syndrome.
Detailed description
Carpal tunnel syndrome is a common compressive neuropathy caused by entrapment of the median nerve at the wrist. It is characterized by pain, numbness, paresthesia, weakness, and functional limitations of the hand, which may negatively affect daily activities and quality of life. Conservative treatment approaches are frequently preferred, particularly in mild to moderate cases, and include wrist splinting, exercise programs, and physical therapy modalities.
This randomized, prospective, single-blind clinical trial was conducted to investigate the effects of peloidotherapy as an adjunct to wrist splint and a home exercise program in individuals with carpal tunnel syndrome. Eligible participants diagnosed with carpal tunnel syndrome were randomly assigned to one of two treatment groups.
The control group received a wrist splint and a structured home exercise program. The intervention group received peloidotherapy in addition to the same wrist splint and home exercise program. Peloidotherapy was applied in standardized 15 sessions under controlled conditions throughout the treatment period.
Clinical and functional assessments were performed at four time points: at baseline before treatment (week 0), at the end of the treatment period (week 3), and during follow-up at one month (week 7) and three months (week 15) after completion of treatment. This assessment schedule was designed to evaluate both short-term and sustained effects of the interventions.
Outcome measures included pain intensity, functional status of the hand, functional disability, quality of life, hand grip strength, neuropathic pain characteristics, and ultrasonographic evaluation of the median nerve, including measurements of the nerve cross-sectional area.
The primary objective of this study was to determine whether the addition of peloidotherapy to wrist splint and a home exercise program provides additional benefits in reducing pain and improving hand function in individuals with carpal tunnel syndrome. Secondary objectives included the evaluation of changes in quality of life, hand grip strength, neuropathic pain features, and ultrasonographic findings during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups. One group received a wrist splint and a home exercise program, while the other group received peloidotherapy in addition to the same wrist splint and home exercise program. Participants remained in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Non-Peloid Therapy Group | Active comparator | Device: Wrist Splint, Other: Home Exercise ProgramParticipants receive treatment consisting of wrist splinting and a structured home exercise program. No peloid therapy is administered. |
| Peloid Therapy Group | Experimental | Other: Peloid Therapy, Device: Wrist Splint, Other: Home Exercise ProgramParticipants receive wrist splinting and a structured home exercise program in addition to peloid therapy. Peloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with mild or mild-to-moderate carpal tunnel syndrome confirmed by electromyography (EMG)
- Presence of clinical symptoms for at least 3 months
- Age 18 years and older
- No limitation in wrist joint range of motion
Key exclusion criteria (12 listed)
- Cervical radiculopathy
- Polyneuropathy
- Pregnancy
- Presence of underlying metabolic diseases (diabetes mellitus, inflammatory rheumatic diseases, thyroid disorders)
- Presence of hand osteoarthritis
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 |
|---|---|---|
| Peloid TherapyPeloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions. | Other | Peloid Therapy Group |
| Wrist SplintParticipants used a neutral-position wrist splint as part of conservative treatment for carpal tunnel syndrome. | Device | Non-Peloid Therapy Group, Peloid Therapy Group |
| Home Exercise ProgramParticipants performed a standardized home exercise program including median nerve gliding exercises and tendon gliding exercises for the wrist and hand. | Other | Non-Peloid Therapy Group, Peloid Therapy Group |
Primary outcome
Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Symptom severity and functional status measured using the Boston Carpal Tunnel Questionnaire (BCTQ), which includes Symptom Severity and Functional Status subscales. Each item is scored from 1 to 5 and subscale scores are calculated as the mean of item scores. Higher scores indicate worse symptoms and functional limitation.
5 secondary outcomes
Median Nerve Cross-Sectional Area
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), and 3-month follow-up (week 15).
QuickDASH Score
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Visual Analog Scale for Pain at Rest
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Visual Analog Scale for Pain During Activity
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Visual Analog Scale for Night Pain
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 29892976Tezcan S, Ulu Ozturk F, Uslu N, Nalbant M, Umit Yemisci O. Carpal Tunnel Syndrome: Evaluation of the Effects of Low-Level Laser Therapy With Ultrasound Strain Imaging. J Ultrasound Med. 2019 Jan;38(1):113-122. doi: 10.1002/jum.14669. Epub 2018 Jun 11.
- Background: PubMed 37906312Yigit F, Ordahan B. Effects of high-intensity laser therapy on pain, functional status, hand grip strength, and median nerve cross-sectional area by ultrasonography in patients with carpal tunnel syndrome. Lasers Med Sci. 2023 Oct 31;38(1):248. doi: 10.1007/s10103-023-03913-z.
- Background: PubMed 28210859Metin Okmen B, Kasapoglu Aksoy M, Gunes A, Eroksuz R, Altan L. Effectiveness of PELOID therapy in carpal tunnel syndrome: A randomized controlled single blind study. Int J Biometeorol. 2017 Aug;61(8):1403-1410. doi: 10.1007/s00484-017-1317-1. Epub 2017 Feb 16.
- Background: PubMed 40358708Sirin Ahisha B, Akkaya Ari S, Paker N, Kesiktas N, Barut Y. Comparison of the efficacy of peloid therapy and paraffin treatment in carpal tunnel syndrome. Int J Biometeorol. 2025 Aug;69(8):1957-1967. doi: 10.1007/s00484-025-02941-4. Epub 2025 May 13.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and legal restrictions related to patient confidentiality and institutional policies.
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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. This study is not recruiting at the moment.
Ebru Yılmaz Yalçınkaya, MD principal investigator
Department of Physical Medicine and Rehabilitation, Gaziosmanpaşa Training and Research Hospital, Istanbul, Turkey
Serap Seringeç Karabulut, MD principal investigator
Department of Medical Ecology and Hydroclimatology, Gaziosmanpaşa Training and Research Hospital, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peloid Therapy, Wrist Splint and Home Exercise Program in people with Carpal Tunnel Syndrome (CTS), run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Questionnaire (BCTQ) (time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07417722, which also lists 4 linked publications.
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 18 Feb 2026.