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

NCT06405438 | Recruiting

• 1 other identifier: BeylikduzuStateH
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; median neuropathy; median nerve; peloid therapy; mud therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  0 day, 4th week and 12th week

Secondary Outcomes (7)

• Visual Analogue Scale

  0 day, 4th week and 12th week

• Median nerve distal motor latency

  0 day, 4th week and 12th week

• Median nerve distal sensory latency

  0 day, 4th week and 12th week

• Sensory nerve conduction velocity

  0 day, 4th week and 12th week

• Motor nerve conduction velocity

  0 day, 4th week and 12th week

Study Arms (2)

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.

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention.

Paraffin treatment group; Peloid therapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with mild and moderate carpal tunnel syndrome

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beylikduzu State Hospital: lead

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Büşra Şirin Ahısha, MD

  Beylikdüzü State Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Büşra Şirin Ahısha

CONTACT

(0212) 856 27 40; bsrn080@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: October 10, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)