Carpal Tunnel Syndrome (CTS)NCT07167667
Median Nerve Thickness of the Carpal Tunnel Syndrome After Two Different Physiotherapy Modalities
A study testing Paraffin Bath and Extracorporeal Shock Wave Therapy in people with Carpal Tunnel Syndrome (CTS), run by Emre Şenocak at 1 site in Turkey (Türkiye).
Trial summary
The study plans to include a total of 60 patients diagnosed with carpal tunnel syndrome. Patients will be divided into two groups according to the treatment they receive. One group will receive only paraffin treatment, while the other group will receive only ESWT treatment. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Paraffin Bath and Extracorporeal Shock Wave Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2024to 25 Oct 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals between the ages of 30-60 who have been diagnosed with CTS by a specialist physician according to international criteria (Those between Stages 1-3),
- Those who have complaints of numbness, tingling, and pain in the first three fingers and half of the fourth finger,
- Phalen Test and Tinel sign or Durkan Test being positive
- Patients who will receive 5 sessions of ESWT application prescribed by a Physical Medicine and Rehabilitation Specialist Physician (for the ESWT group)
- Patients who have been recommended 10 sessions of Paraffin application by a Physical Medicine and Rehabilitation Specialist Physician (for the Paraffin group)
Who cannot join
- Presence of atrophy in the thenar muscles,
- Insufficient sensory and motor response in the median nerve,
- History of hand and/or wrist injury or surgery,
- Those with cervical stenosis, cervical spondylosis, or cervical radiculopathy,
- Corticosteroids in the carpal tunnel area within the last six months those who have had an injection,
- Pregnancy or diabetes, renal failure, rheumatoid arthritis or hypothyroidism
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, 1 recruiting
- Recruiting
Baltalimani Metin Sabanci Bone Diseases Training and Research Hospita
Istanbul
Esra Sonbahar Bolat, Physican, +905052686709, esra.sonbahar@hotmail.com
About this study
Official title: Investigation of the Effects of Two Different Physiotherapy Modalities on Median Nerve Thickness, Electrophysiological Activity, Pain Intensity and Quality of Life in Patients With Carpal Tunnel Syndrome - An Observational Study
The study plans to include a total of 60 patients diagnosed with carpal tunnel syndrome. Patients will be divided into two groups according to the treatment they receive. One group will receive only paraffin treatment, while the other group will receive only ESWT treatment. ESWT will be applied for a total of 5 sessions. Paraffin will be applied for a total of 10 sessions. As assessment tools;
- Measurement of median nerve thickness with ultrasound
- Electromyography
- Visual Analog Scale
- Short Form-36
Evaluations will be made twice by a specialist physician before and after the treatments.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Paraffin Bath, Extracorporeal Shock Wave Therapy
- Keywords
- Median Nerve Thickness, Ultrasound, Electromyograpy, Physiotherapy, ESWT, Paraffin
- 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.
Paraffin BathOther
Patients' hands will be dipped into the paraffin bath 8-10 times.
Extracorporeal Shock Wave TherapyOther
The patients will be treated with a sound wave pulse frequency of 15 Hz, an intensity of 1.5 bar, and a total number of pulses of 2000 for one session.
| Study group | Role | What they receive |
|---|---|---|
| Paraffin | Experimental | Not described Receives: Other: Paraffin Bath |
| ESWT | Experimental | Not described Receives: Other: Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Nerve Thickness
Median nerve thickness will be measured by ultrasound
Measured: Baseline
Median Nerve Thickness
Median nerve thickness will be measured by ultrasound
Measured: 5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention
Secondary outcomes (5)
Electromyography
EMG will be used to diagnose carpal tunnel.
Measured: Baseline
Visual Analog Scale
It will be used to assess pain intensity.
Measured: Baseline
Visual Analog Scale
It will be used to assess pain intensity.
Measured: 5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention
Short Form-36
It will be used to evaluate patients' quality of life.
Measured: Baseline
Short Form-36
It will be used to evaluate patients' quality of life.
Measured: 5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start25 Oct 2024
- Primary completion25 Oct 2025 (estimated)
- Study completion25 Oct 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 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emre Şenocak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre Şenocak, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167667
- Sponsor's protocol ID
- 2024/145
- Status last verified
- Sep 2025
- First submitted
- 11 Jun 2025
- Last updated
- 11 Sep 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Two Different Physiotherapy Modalities on Median Nerve Thickness, Electrophysiological Activity, Pain Intensity and Quality of Life in Patients With Carpal Tunnel Syndrome - An Observational Study
- ClinicalTrials.gov ID
- NCT07167667
- Acronym / sponsor ID
- 2024/145
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Median Nerve Thickness, Ultrasound, Electromyograpy, Physiotherapy, ESWT, Paraffin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Emre ŞenocakUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 25 Oct 2025 (estimated)
- Study completion
- 25 Oct 2025 (estimated)
- First posted
- 11 Sep 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.
The study plans to include a total of 60 patients diagnosed with carpal tunnel syndrome. Patients will be divided into two groups according to the treatment they receive. One group will receive only paraffin treatment, while the other group will receive only ESWT treatment. ESWT will be applied for a total of 5 sessions. Paraffin will be applied for a total of 10 sessions. As assessment tools;
- Measurement of median nerve thickness with ultrasound
- Electromyography
- Visual Analog Scale
- Short Form-36
Evaluations will be made twice by a specialist physician before and after the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paraffin | Experimental | Other: Paraffin Bath |
| ESWT | Experimental | Other: Extracorporeal Shock Wave Therapy |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals between the ages of 30-60 who have been diagnosed with CTS by a specialist physician according to international criteria (Those between Stages 1-3),
- Those who have complaints of numbness, tingling, and pain in the first three fingers and half of the fourth finger,
- Phalen Test and Tinel sign or Durkan Test being positive
- Patients who will receive 5 sessions of ESWT application prescribed by a Physical Medicine and Rehabilitation Specialist Physician (for the ESWT group)
- Patients who have been recommended 10 sessions of Paraffin application by a Physical Medicine and Rehabilitation Specialist Physician (for the Paraffin group)
Key exclusion criteria (6 listed)
- Presence of atrophy in the thenar muscles,
- Insufficient sensory and motor response in the median nerve,
- History of hand and/or wrist injury or surgery,
- Those with cervical stenosis, cervical spondylosis, or cervical radiculopathy,
- Corticosteroids in the carpal tunnel area within the last six months those who have had an injection,
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 |
|---|---|---|
| Paraffin BathPatients' hands will be dipped into the paraffin bath 8-10 times. | Other | Paraffin |
| Extracorporeal Shock Wave TherapyThe patients will be treated with a sound wave pulse frequency of 15 Hz, an intensity of 1.5 bar, and a total number of pulses of 2000 for one session. | Other | ESWT |
Primary outcome
Median Nerve Thickness
Time frame: Baseline
Median nerve thickness will be measured by ultrasound
Median Nerve Thickness
Time frame: 5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention
Median nerve thickness will be measured by ultrasound
5 secondary outcomes
Electromyography
Time frame: Baseline
Visual Analog Scale
Time frame: Baseline
Visual Analog Scale
Time frame: 5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention
Short Form-36
Time frame: Baseline
Short Form-36
Time frame: 5 days later for the first ESWT intervention and 10 days later for the first Paraffin Intervention
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 11 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraffin Bath and Extracorporeal Shock Wave Therapy in people with Carpal Tunnel Syndrome (CTS), run by Emre Şenocak 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Sep 2025. 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?
Contact Esra Sonbahar Bolat, Physician (+9005052686709, esra.sonbahar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Nerve Thickness (time frame: Baseline). 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 11 Sep 2025.