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

Carpal Tunnel Syndrome Clinical Trial

Official title:

Comparison of the Efficacy of Peloid Therapy and Paraffin Treatment in Carpal Tunnel Syndrome: A Randomized Prospective Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405438
• Other study ID #: BeylikduzuStateH
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: Beylikduzu State Hospital
• Contact: Büsra Sirin Ahisha
• Phone: (0212) 856 27 40
• Email: bsrn080[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares the effectiveness of peloid therapy and paraffin treatment in carpal tunnel syndrome. Patients receive either 2 weeks of peloid therapy or 15 sessions of paraffin treatment, along with splint therapy for 3 months. Pain and symptom severity are assessed using the Visual Analog Scale (VAS) and Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Results are measured at baseline, 4 weeks post-treatment, and a 12-week follow-up.

Description:

This study aims to compare the effectiveness of peloid therapy and paraffin treatment in patients with carpal tunnel syndrome through a randomized prospective clinical trial. Prior to treatment, electrophysiological evaluations will be conducted, and pain severity will be assessed using the Visual Analog Scale (VAS). The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) will be utilized to evaluate the type and severity of symptoms. Patients will be randomly divided into two groups: one group will receive peloid therapy for 2 weeks, administered on consecutive days for 5 days a week, while the other group will receive paraffin treatment for a total of 15 sessions, administered 5 days a week. Additionally, both groups will be advised to use splint therapy, especially at night, for a duration of 3 months. VAS scores, BCTQ scores, and electrophysiological evaluations 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) amplitudes will be recorded at baseline, 4 weeks post-treatment, and at the 12-week follow-up.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• physical therapy
Patients will have their affected hand or hands immersed in a mixture of heated paraffin wax. Each session will last approximately 20-30 minutes. Patients will undergo application of natural mud, rich in minerals, to the affected area.

Locations

Country	Name	City	State
Turkey	Beylikdüzü State Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Beylikduzu State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Carpal Tunnel Syndrome Questionnaire	The Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.	0 day, 4th week and 12th week
Secondary	Visual Analogue Scale	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain.	0 day, 4th week and 12th week
Secondary	Median nerve distal motor latency	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Secondary	Median nerve distal sensory latency	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Secondary	Sensory nerve conduction velocity	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Secondary	Motor nerve conduction velocity	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Secondary	Sensory nerve action potential amplitude	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Secondary	Motor nerve action potential amplitude	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week