Clinical trial NCT06405438: Comparison of the Efficacy of Peloid Therapy and Paraffin Treatment in Carpal Tunnel Syndrome
Official title: Comparison of the Efficacy of Peloid Therapy and Paraffin Treatment in Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
median neuropathy
median nerve
peloid therapy
mud therapy
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with mild and moderate carpal tunnel syndrome

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: 0 day, 4th week and 12th week
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 0 day, 4th week and 12th week
measure: Median nerve distal motor latency
timeFrame: 0 day, 4th week and 12th week
measure: Median nerve distal sensory latency
timeFrame: 0 day, 4th week and 12th week
measure: Sensory nerve conduction velocity
timeFrame: 0 day, 4th week and 12th week
measure: Motor nerve conduction velocity
timeFrame: 0 day, 4th week and 12th week
measure: Sensory nerve action potential amplitude
timeFrame: 0 day, 4th week and 12th week
measure: Motor nerve action potential amplitude
timeFrame: 0 day, 4th week and 12th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
Study officials:
affiliation: Beylikdüzü State Hospital
name: Büşra Şirin Ahısha, MD
role: PRINCIPAL_INVESTIGATOR
References: