Carpal Tunnel SyndromeNCT06405438
Comparison of the Efficacy of Peloid Therapy and Paraffin Treatment in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study compares the effectiveness of peloid therapy and paraffin treatment in carpal tunnel syndrome. Patients who have already received 2 weeks of peloid therapy or 15 sessions of paraffin treatment will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2024to 20 Jan 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mild and moderate carpal tunnel syndrome
Who may be able to join
- Patients aged between 18 and 65 years old.
- Patients diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological evaluations.
- Patients experiencing symptoms for a minimum of 3 months.
Who cannot join
- Patients diagnosed with neuropathic conditions such as polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
- Patients with a history of previous injections or surgery for carpal tunnel syndrome.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beylikdüzü State Hospital
Istanbul, 34147
Büşra Şirin Ahısha, MD, (0212) 856 27 40, bsrn080@gmail.com
Büşra Şirin Ahısha, MD
About this study
This study compares the effectiveness of peloid therapy and paraffin treatment in carpal tunnel syndrome. Patients who have already received 2 weeks of peloid therapy or 15 sessions of paraffin treatment will be assessed. Pain and symptom severity are assessed using the Visual Analog Scale (VAS) and Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Electrophysiological examinations will also be conducted at the same time points: baseline, 4 weeks post-treatment, and a 12-week follow-up.
Read the detailed description
Our study will include 60 patients aged 18-65 who visited the outpatient clinics of Beylikdüzü State Hospital between January 1, 2024, and September 1, 2024, and were diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological examinations. These patients received either peloid or paraffin treatment. Patients with symptoms persisting for a minimum of 3 months will be included in the study. In this study, pain levels will be evaluated using the Visual Analog Scale (VAS), and the type and severity of symptoms will be assessed with the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). At our hospital, the standard paraffin treatment consists of 15 sessions, administered 5 days per week, while the peloid therapy consists of 10 sessions, also administered 5 days per week. The VAS, BCTQ scores, and electrophysiological evaluations of the patients will be assessed at the 4th and 12th weeks post-treatment. Electrophysiological parameters including median nerve distal motor latency (MMNDL), median nerve distal sensory latency (MNSDL), sensory nerve conduction velocity (SNCV), compound muscle action potential (CMAP), and sensory nerve action potential (SNAP) will be recorded.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- No intervention
- Keywords
- carpal tunnel syndrome, median neuropathy, median nerve, peloid therapy, mud therapy
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Peloid therapy group | Patients in this group have already received peloid therapy for their carpal tunnel syndrome. Peloid therapy involves the application of natural mud, typically rich in minerals, to the affected area. The sessions will also last approximately 20-30 minutes per day, administered consecutively for 5 days a week, totaling 10 sessions for 2 weeks. Receives: Other: No intervention | |
| Paraffin treatment group | In this group, patients have already received paraffin treatment for their carpal tunnel syndrome. Paraffin treatment involves immersing the affected hand or hands in a mixture of heated paraffin wax. The sessions will last approximately 20-30 minutes per day, 5 days a week, for a total of 15 sessions for 3 weeks. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Syndrome Questionnaire
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) consists of two parts: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). Both parts are scored on a 5-point Likert scale, with higher scores indicating worse symptoms or functional impairment.The highest possible total score for the Symptom Severity Scale is 55, which reflects the most severe symptoms.The highest possible total score for the Functional Status Scale is 40, indicating the greatest functional impairment.The minimum total score is 19 (indicating minimal or no symptoms and functional limitations).
The maximum total score is 95 (indicating the most severe symptoms and functional limitations).
As the total score increases, the severity of symptoms and functional limitations worsens, meaning higher scores reflect worse outcomes.
Measured: 0 day, 4th week and 12th week
Secondary outcomes (7)
Visual Analogue Scale
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain.
The Visual Analog Scale (VAS) is a tool used to measure pain intensity. It is typically represented as a 10 cm or 100 mm line, where the patient marks their pain level.
The minimum score is 0, which indicates no pain. The maximum score is 100, indicating the worst possible pain. As the score increases, the severity of pain worsens. In this scale, higher scores reflect more intense pain levels. The Visual Analog Scale (VAS) ranges from 0 to 100 where higher scores reflect greater pain intensity.
Measured: 0 day, 4th week and 12th week
Median nerve distal motor latency
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Median nerve distal sensory latency
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Sensory nerve conduction velocity
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Motor nerve conduction velocity
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Sensory nerve action potential amplitude
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Motor nerve action potential amplitude
It is a finding from electrophysiological evaluation
Measured: 0 day, 4th week and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start10 Oct 2024
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Jan 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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
- Investigators
- Büşra Şirin Ahısha, MD, Principal investigator, Beylikdüzü State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405438
- Sponsor's protocol ID
- BeylikduzuStateH
- Status last verified
- Oct 2024
- First submitted
- 5 May 2024
- Last updated
- 26 Oct 2024
- 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Peloid Therapy and Paraffin Treatment in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06405438
- Acronym / sponsor ID
- BeylikduzuStateH
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, median neuropathy, median nerve, peloid therapy, mud therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 8 May 2024 (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.
This study compares the effectiveness of peloid therapy and paraffin treatment in carpal tunnel syndrome. Patients who have already received 2 weeks of peloid therapy or 15 sessions of paraffin treatment will be assessed. Pain and symptom severity are assessed using the Visual Analog Scale (VAS) and Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Electrophysiological examinations will also be conducted at the same time points: baseline, 4 weeks post-treatment, and a 12-week follow-up.
Detailed description
Our study will include 60 patients aged 18-65 who visited the outpatient clinics of Beylikdüzü State Hospital between January 1, 2024, and September 1, 2024, and were diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological examinations. These patients received either peloid or paraffin treatment. Patients with symptoms persisting for a minimum of 3 months will be included in the study. In this study, pain levels will be evaluated using the Visual Analog Scale (VAS), and the type and severity of symptoms will be assessed with the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). At our hospital, the standard paraffin treatment consists of 15 sessions, administered 5 days per week, while the peloid therapy consists of 10 sessions, also administered 5 days per week. The VAS, BCTQ scores, and electrophysiological evaluations of the patients will be assessed at the 4th and 12th weeks post-treatment. Electrophysiological parameters including median nerve distal motor latency (MMNDL), median nerve distal sensory latency (MNSDL), sensory nerve conduction velocity (SNCV), compound muscle action potential (CMAP), and sensory nerve action potential (SNAP) will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peloid therapy group | – | Other: No interventionPatients in this group have already received peloid therapy for their carpal tunnel syndrome. Peloid therapy involves the application of natural mud, typically rich in minerals, to the affected area. The sessions will also last approximately 20-30 minutes per day, administered consecutively for 5 days a week, totaling 10 sessions for 2 weeks. |
| Paraffin treatment group | – | Other: No interventionIn this group, patients have already received paraffin treatment for their carpal tunnel syndrome. Paraffin treatment involves immersing the affected hand or hands in a mixture of heated paraffin wax. The sessions will last approximately 20-30 minutes per day, 5 days a week, for a total of 15 sessions for 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mild and moderate carpal tunnel syndrome
Key inclusion criteria (3 listed)
- Patients aged between 18 and 65 years old.
- Patients diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological evaluations.
- Patients experiencing symptoms for a minimum of 3 months.
Key exclusion criteria (2 listed)
- Patients diagnosed with neuropathic conditions such as polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
- Patients with a history of previous injections or surgery for carpal tunnel syndrome.
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 |
|---|---|---|
| No interventionNo intervention. | Other | Paraffin treatment group, Peloid therapy group |
Primary outcome
Boston Carpal Tunnel Syndrome Questionnaire
Time frame: 0 day, 4th week and 12th week
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) consists of two parts: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). Both parts are scored on a 5-point Likert scale, with higher scores indicating worse symptoms or functional impairment.The highest possible total score for the Symptom Severity Scale is 55, which reflects the most severe symptoms.The highest possible total score for the Functional Status Scale is 40, indicating the greatest functional impairment.The minimum total score is 19 (indicating minimal or no symptoms and functional limitations). The maximum total score is 95 (indicating the most severe symptoms and functional limitations). As the total score increases, the severity of symptoms and functional limitations worsens, meaning higher scores reflect worse outcomes.
7 secondary outcomes
Visual Analogue Scale
Time frame: 0 day, 4th week and 12th week
Median nerve distal motor latency
Time frame: 0 day, 4th week and 12th week
Median nerve distal sensory latency
Time frame: 0 day, 4th week and 12th week
Sensory nerve conduction velocity
Time frame: 0 day, 4th week and 12th week
Motor nerve conduction velocity
Time frame: 0 day, 4th week and 12th week
Sensory nerve action potential amplitude
Time frame: 0 day, 4th week and 12th week
Motor nerve action potential amplitude
Time frame: 0 day, 4th week and 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- 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. This study is not recruiting at the moment.
Büşra Şirin Ahısha, MD principal investigator
Beylikdüzü State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Beylikduzu State 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 2 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: status not confirmed, as of the sponsor's last update on 26 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Büşra Şirin Ahısha ((0212) 856 27 40, bsrn080@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Syndrome Questionnaire (time frame: 0 day, 4th week and 12th week). 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 26 Oct 2024.