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

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Büşra Şirin Ahısha; Phone Number: (0212) 856 27 40; Email: bsrn080@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34147
    • Recruiting
    • Beylikdüzü State Hospital
    • Contact: Büşra Şirin Ahısha, MD; Phone Number: (0212) 856 27 40; Email: bsrn080@gmail.com
    • Principal Investigator: Büşra Şirin Ahısha, MD
    • Sub-Investigator: Selma Akkaya Arı, MD
    • Sub-Investigator: Nurdan Paker, MD
    • Sub-Investigator: Nur Kesiktaş, MD
    • Sub-Investigator: Yasemin Barut, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with mild and moderate carpal tunnel syndrome

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median nerve distal motor latency	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Median nerve distal sensory latency	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Sensory nerve conduction velocity	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Motor nerve conduction velocity	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Sensory nerve action potential amplitude	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Motor nerve action potential amplitude	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
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.	0 day, 4th week and 12th week

Collaborators and Investigators

• Sponsor: Beylikduzu State Hospital
• Investigators: Principal Investigator: Büşra Şirin Ahısha, MD, Beylikdüzü State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): January 20, 2025
• Study Completion (Estimated): January 20, 2025

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; median nerve; peloid therapy; mud therapy; median neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Disease; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: BeylikduzuStateH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No