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Recruiting NCT06405438

Comparison of the Efficacy of Peloid Therapy and Paraffin Treatment in Carpal Tunnel Syndrome

Observational Carpal Tunnel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Carpal Tunnel Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other No intervention
    No intervention.

Primary outcome measures

  • Boston Carpal Tunnel Syndrome Questionnaire [Time frame: 0 day, 4th week and 12th week]
Secondary outcome measures (7)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Beylikdüzü State Hospital — Istanbul

Identifiers

NCT: NCT06405438 · BeylikduzuStateH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗