Carpal Tunnel Syndrome (CTS)NCT06986668
Efficacy of Paraffin Bath and Peloidotherapy in Carpal Tunnel Syndrome
A study testing Peloidotherapy, paraffin bath and home exersize in people with Carpal Tunnel Syndrome (CTS) and Peloidotherapy, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients diagnosed with mild and moderate idiopathic CTS will be randomly divided into three groups. Patients who received 15 sessions of peloid therapy along with a home exercise program will constitute the first group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS), Peloidotherapy, Paraffin Bath
- What is being tested?
- Peloidotherapy, paraffin bath and home exersize
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2025to 30 Dec 2026
- 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
- Being between the ages of 18-65
- Agreeing to participate voluntarily in the study
- Being diagnosed with mild or moderate idiopathic chronic CTS as a result of anamnesis, clinical examination and nerve conduction study
Who cannot join
- Presence of predisposing etiological factors for CTS such as diabetes mellitus, chronic kidney and liver disease, acromegaly, rheumatological diseases, acute trauma, hypothyroidism, etc.
- Being diagnosed with severe CTS
- Having a history of previous wrist surgery or trauma
- Having atrophy in the thenar region or weakness in the thenar muscles
- Having cervical radiculopathy, thoracic outlet syndrome, polyneuropathy, brachial neuropathy or proximal median nerve neuropathy
- Having had steroid injections in the last 3 months and taking oral steroid medications
Show all 10Show fewer
- Being pregnant
- Having an open wound or rash in the wrist and its surroundings that would prevent treatment
- Patients who are receiving or will receive another/additional treatment for CTS
- Patients with a bifid median nerve, persistent median artery, ganglion cyst, tenosynovitis, or tendinitis in the wrist.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Konya Beyhekim Training and Research Hospital
Konya
About this study
Official title: Comparison of the Efficacy of Paraffin Bath and Peloidotherapy in Patients With Carpal Tunnel Syndrome
Patients diagnosed with mild and moderate idiopathic CTS will be randomly divided into three groups. Patients who received 15 sessions of peloid therapy along with a home exercise program will constitute the first group. The second group will consist of patients who receive 15 sessions of paraffin bath and a home exercise program. Patients who were given only a home exercise program will be included in the third group. "Patients will be evaluated in detail in terms of clinical examination and outcomes three weeks after the end of treatment and again at three months.
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common compression neuropathy caused by entrapment of the median nerve in the carpal tunnel. There are 2 methods for the treatment of CTS: conservative and surgical. Conservative treatment is mostly applied in patients with mild and moderate CTS. In this study, we aim to evaluate the efficacy of peloid therapy and kinesiobanding technique, which are conservative treatment methods. Patients will be evaluated in terms of pain, functional/symptom status, hand-finger strength, median nerve ultrasonography measurements.
Patients who were evaluated by detailed clinical examination and medical history according to the inclusion and exclusion criteria were given written informed consent and assigned to one of the three treatment groups using block randomization. Basic sociodemographic information (age, gender, body mass index, employment status, education level, marital status,etc) and clinical data (dominant hand, duration of symptoms, comorbidities, hand to be treated, Tinel/Phalen sign, pain intensity, baseline electrophysiological parameters) will be recorded. The first group will consist of patients who have received peloid therapy at 45 degrees for a total of 15 sessions of 20 minutes, 5 days a week for 3 weeks with a home-based exercise program. The second group is a program consisting of adults who receive a total of 15 sessions of 20 minutes, paraffin bath treatment and home exercise program, 5 days a week for 3 weeks. Patients who only received home-based exercise program will be included in the 3rd group. During the treatment period, patients will be allowed to take only paracetamol for pain, if necessary, except for the medications they use continuously for comorbid reasons.
All groups were evaluated by a blinded assessor based on examination findings (Tinel/Phalen tests), pain intensity (VAS), hand grip strength (HGS), finger pinch strength (FGS), the Turkish version of the Boston Carpal Tunnel Questionnaire, the 4-Question Neuropathic Pain Questionnaire (DN4),Quick DASH Score, and ultrasound measurements (median nerve cross-sectional areas [CSA]) at the proximal insertion of the carpal tunnel (at the level of the scaphoid and pisiform bones and the distal wrist crease), both after treatment (three weeks/W3) and at three months post-treatment (W12).
- Conditions
- Carpal Tunnel Syndrome (CTS), Peloidotherapy, Paraffin Bath, Exercise
- Being tested
- Peloidotherapy, paraffin bath, home exersize
- Keywords
- carpal tunnel syndrome (CTS), Peloidotherapy, paraffin bath, exercise, ultrasound, pain
- Medical subject headings
- Carpal Tunnel Syndrome, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeloidotherapyOther
Peloidotherapy stands out among superficial heating physical therapy modalities with its mineral and natural origin.
paraffin bathOther
It is an effective treatment for the treatment of patients' hands, arms and feet by applying the brushing method to different body parts, relieving pain and improving function, thus providing freedom of life.
home exersizeOther
Flexor tendon gliding exercises, median nerve gliding exercises, and isometric wrist strengthening exercises will be given as exercises.
| Study group | Role | What they receive |
|---|---|---|
| Peloidotherapy | Experimental | This group will consist of patients who have received peloid therapy for a total of 15 sessions of 20 minutes at 45 degrees for 3 weeks, 5 days a week, along with a home exercise program. Receives: Other: Peloidotherapy; Other: home exersize |
| paraffin bath | Experimental | This group will consist of patients who have received paraffin bath for a total of 15 sessions of 20 minutes for 3 weeks, 5 days a week, along with a home exercise program. Receives: Other: paraffin bath; Other: home exersize |
| Home exercise | Experimental | This group will consist of patients who have only been given a home exercise program. Flexor tendon gliding exercises, median nerve gliding exercises, and isometric wrist strengthening exercises will be given as exercises. Receives: Other: home exersize |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain
A 10 cm long line is drawn, this line is divided into 10 intervals of 10 mm width, 0: no pain and 10: the most severe pain is explained, and the patient is asked to mark the value corresponding to the resting pain and the pain during movement on the scale.
Measured: baseline, week 3 and week 12
The Boston Carpal Tunnel Syndrome Questionnaire
The Turkish version of the Boston Carpal Tunnel Questionnaire score. It is used to evaluate the symptom severity and functionality of the patients. BCTQ is a questionnaire consisting of 2 parts: symptom severity scale (SSS) and functional status scale (FSS). Each item in both sections has 5 different answers that score between 1 and 5. The mean score is obtained by dividing the total score by the number of questions and ranges from 1 to 5, with a higher score indicating severe symptom.
Measured: baseline, week 3 and week 12
Secondary outcomes (5)
Hand grip strength
Following the definitions outlined in the literature, HGS will be measured using Jamar hand dynamometers. The patients will be asked to squeeze the dynamometer three times with maximum strength, allowing 30-60 seconds of rest between each attempt. The average force (in pounds/kg) will then be recorded.
Measured: baseline, week 3 and week 12
Finger pinch strength
Following the definitions outlined in the literature, FGS will be measured using Baseline pinch dynamometers. The patients will be asked to squeeze the dynamometer three times with maximum strength, allowing 30-60 seconds of rest between each attempt. The average force (in pounds/kg) will then be recorded.
Measured: baseline, week 3 and week 12
Douleur Neuropathique 4
The DN4 is a short and simple screening test designed to help distinguish neuropathic pain from other types of pain, such as nociceptive pain. Neuropathic pain is assessed with four questions. The first two questions are based on the patient interview and the other two questions are based on the clinical examination.
Measured: baseline, week 3 and week 12
Quick DASH Score
The purpose of the QuickDASH is to use 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The QuickDASH is a widely used reference of self-reported disability.
Measured: baseline, week 3 and week 12
Ultrasonographic evaluation of the median nerve
Ultrasonographic evaluation of the median nerve will be performed with a LA2-14A transducer /superficial linear probe (Samsung). The cross-sectional areas (CSA) of the median nerve at the proximal inlet of the carpal tunnel will be recorded. To identify the entrance of the carpal tunnel, measurements will be taken at the level of the distal wrist crease, at the scaphoid and pisiform bones. The assessments were conducted with the patients seated, facing the clinician, with their elbow bent at approximately 90˚, forearm in a supine position, and fingers in a semiflexed posture. Measurements were obtained using the manual tracing feature of the ultrasound device, excluding the hyperechoic nerve sheathThe CSA (mm2) will be determined. The average of the three measurements will be recorded.
Measured: baseline, week 3 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start25 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- single-blind, randomized, prospective
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ümmü Habibe Sarı, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986668
- Sponsor's protocol ID
- KonyaBeyhekimTRH9188
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 30 Mar 2026
- 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Paraffin Bath and Peloidotherapy in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06986668
- Acronym / sponsor ID
- KonyaBeyhekimTRH9188
- Conditions
- Carpal Tunnel Syndrome (CTS), Peloidotherapy, Paraffin Bath, Exercise
- Keywords
- carpal tunnel syndrome (CTS), Peloidotherapy, paraffin bath, exercise, ultrasound, pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 25 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 May 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.
Patients diagnosed with mild and moderate idiopathic CTS will be randomly divided into three groups. Patients who received 15 sessions of peloid therapy along with a home exercise program will constitute the first group. The second group will consist of patients who receive 15 sessions of paraffin bath and a home exercise program. Patients who were given only a home exercise program will be included in the third group. "Patients will be evaluated in detail in terms of clinical examination and outcomes three weeks after the end of treatment and again at three months.
Detailed description
Carpal tunnel syndrome (CTS) is the most common compression neuropathy caused by entrapment of the median nerve in the carpal tunnel. There are 2 methods for the treatment of CTS: conservative and surgical. Conservative treatment is mostly applied in patients with mild and moderate CTS. In this study, we aim to evaluate the efficacy of peloid therapy and kinesiobanding technique, which are conservative treatment methods. Patients will be evaluated in terms of pain, functional/symptom status, hand-finger strength, median nerve ultrasonography measurements.
Patients who were evaluated by detailed clinical examination and medical history according to the inclusion and exclusion criteria were given written informed consent and assigned to one of the three treatment groups using block randomization. Basic sociodemographic information (age, gender, body mass index, employment status, education level, marital status,etc) and clinical data (dominant hand, duration of symptoms, comorbidities, hand to be treated, Tinel/Phalen sign, pain intensity, baseline electrophysiological parameters) will be recorded. The first group will consist of patients who have received peloid therapy at 45 degrees for a total of 15 sessions of 20 minutes, 5 days a week for 3 weeks with a home-based exercise program. The second group is a program consisting of adults who receive a total of 15 sessions of 20 minutes, paraffin bath treatment and home exercise program, 5 days a week for 3 weeks. Patients who only received home-based exercise program will be included in the 3rd group. During the treatment period, patients will be allowed to take only paracetamol for pain, if necessary, except for the medications they use continuously for comorbid reasons.
All groups were evaluated by a blinded assessor based on examination findings (Tinel/Phalen tests), pain intensity (VAS), hand grip strength (HGS), finger pinch strength (FGS), the Turkish version of the Boston Carpal Tunnel Questionnaire, the 4-Question Neuropathic Pain Questionnaire (DN4),Quick DASH Score, and ultrasound measurements (median nerve cross-sectional areas [CSA]) at the proximal insertion of the carpal tunnel (at the level of the scaphoid and pisiform bones and the distal wrist crease), both after treatment (three weeks/W3) and at three months post-treatment (W12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- single-blind, randomized, prospective
| Arm | Type | Receives |
|---|---|---|
| Peloidotherapy | Experimental | Other: Peloidotherapy, Other: home exersizeThis group will consist of patients who have received peloid therapy for a total of 15 sessions of 20 minutes at 45 degrees for 3 weeks, 5 days a week, along with a home exercise program. |
| paraffin bath | Experimental | Other: paraffin bath, Other: home exersizeThis group will consist of patients who have received paraffin bath for a total of 15 sessions of 20 minutes for 3 weeks, 5 days a week, along with a home exercise program. |
| Home exercise | Experimental | Other: home exersizeThis group will consist of patients who have only been given a home exercise program. Flexor tendon gliding exercises, median nerve gliding exercises, and isometric wrist strengthening exercises will be given as exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-65
- Agreeing to participate voluntarily in the study
- Being diagnosed with mild or moderate idiopathic chronic CTS as a result of anamnesis, clinical examination and nerve conduction study
Key exclusion criteria (10 listed)
- Presence of predisposing etiological factors for CTS such as diabetes mellitus, chronic kidney and liver disease, acromegaly, rheumatological diseases, acute trauma, hypothyroidism, etc.
- Being diagnosed with severe CTS
- Having a history of previous wrist surgery or trauma
- Having atrophy in the thenar region or weakness in the thenar muscles
- Having cervical radiculopathy, thoracic outlet syndrome, polyneuropathy, brachial neuropathy or proximal median nerve neuropathy
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 |
|---|---|---|
| PeloidotherapyPeloidotherapy stands out among superficial heating physical therapy modalities with its mineral and natural origin. | Other | Peloidotherapy |
| paraffin bathIt is an effective treatment for the treatment of patients' hands, arms and feet by applying the brushing method to different body parts, relieving pain and improving function, thus providing freedom of life. | Other | paraffin bath |
| home exersizeFlexor tendon gliding exercises, median nerve gliding exercises, and isometric wrist strengthening exercises will be given as exercises. | Other | Home exercise, Peloidotherapy, paraffin bath |
Primary outcome
VAS pain
Time frame: baseline, week 3 and week 12
A 10 cm long line is drawn, this line is divided into 10 intervals of 10 mm width, 0: no pain and 10: the most severe pain is explained, and the patient is asked to mark the value corresponding to the resting pain and the pain during movement on the scale.
The Boston Carpal Tunnel Syndrome Questionnaire
Time frame: baseline, week 3 and week 12
The Turkish version of the Boston Carpal Tunnel Questionnaire score. It is used to evaluate the symptom severity and functionality of the patients. BCTQ is a questionnaire consisting of 2 parts: symptom severity scale (SSS) and functional status scale (FSS). Each item in both sections has 5 different answers that score between 1 and 5. The mean score is obtained by dividing the total score by the number of questions and ranges from 1 to 5, with a higher score indicating severe symptom.
5 secondary outcomes
Hand grip strength
Time frame: baseline, week 3 and week 12
Finger pinch strength
Time frame: baseline, week 3 and week 12
Douleur Neuropathique 4
Time frame: baseline, week 3 and week 12
Quick DASH Score
Time frame: baseline, week 3 and week 12
Ultrasonographic evaluation of the median nerve
Time frame: baseline, week 3 and week 12
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 30 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peloidotherapy, paraffin bath and home exersize in people with Carpal Tunnel Syndrome (CTS) and Peloidotherapy, run by Konya Beyhekim Training and Research 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 3 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 30 Mar 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?
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?
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?
VAS pain (time frame: baseline, week 3 and week 12). The study lists 2 primary outcomes in all. 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 30 Mar 2026.