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Investigation of the Effects of Peloidotherapy on Pain Severity, Functional Status, and Ultrasonographic Findings in Patients With Carpal Tunnel Syndrome: A Randomized, Prospective, Single-Blind Study
Carpal tunnel syndrome is a common condition caused by pressure on a nerve at the wrist. It can lead to pain, numbness, weakness, and difficulty using the hand during daily activities. In this clinical trial, researchers will study a non-drug treatment approach for people with carpal tunnel syndrome. Participants will be randomly assigned to one of two groups. One group will receive a wrist splint and a home exercise program. The other group will receive peloidotherapy in addition to the same splint and exercise program. Pain, hand function, daily activities, quality of life, hand strength, and ultrasound findings of the median nerve will be evaluated before treatment, at the end of treatment, and during follow-up periods. The goal of this study is to determine whether adding peloidotherapy to wrist splint and a home exercise program provides additional benefits in reducing pain and improving hand function in people with carpal tunnel syndrome.
Carpal tunnel syndrome is a common compressive neuropathy caused by entrapment of the median nerve at the wrist. It is characterized by pain, numbness, paresthesia, weakness, and functional limitations of the hand, which may negatively affect daily activities and quality of life. Conservative treatment approaches are frequently preferred, particularly in mild to moderate cases, and include wrist splinting, exercise programs, and physical therapy modalities. This randomized, prospective, single-blind clinical trial was conducted to investigate the effects of peloidotherapy as an adjunct to wrist splint and a home exercise program in individuals with carpal tunnel syndrome. Eligible participants diagnosed with carpal tunnel syndrome were randomly assigned to one of two treatment groups. The control group received a wrist splint and a structured home exercise program. The intervention group received peloidotherapy in addition to the same wrist splint and home exercise program. Peloidotherapy was applied in standardized 15 sessions under controlled conditions throughout the treatment period. Clinical and functional assessments were performed at four time points: at baseline before treatment (week 0), at the end of the treatment period (week 3), and during follow-up at one month (week 7) and three months (week 15) after completion of treatment. This assessment schedule was designed to evaluate both short-term and sustained effects of the interventions. Outcome measures included pain intensity, functional status of the hand, functional disability, quality of life, hand grip strength, neuropathic pain characteristics, and ultrasonographic evaluation of the median nerve, including measurements of the nerve cross-sectional area. The primary objective of this study was to determine whether the addition of peloidotherapy to wrist splint and a home exercise program provides additional benefits in reducing pain and improving hand function in individuals with carpal tunnel syndrome. Secondary objectives included the evaluation of changes in quality of life, hand grip strength, neuropathic pain features, and ultrasonographic findings during follow-up.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Gaziosmanpaşa Training and Research Hospital
Istanbul, Turkey (Türkiye)
Start Date
June 1, 2025
Primary Completion Date
September 11, 2025
Completion Date
January 15, 2026
Last Updated
February 18, 2026
70
ACTUAL participants
Peloid Therapy
OTHER
Wrist Splint
DEVICE
Home Exercise Program
OTHER
Lead Sponsor
Gaziosmanpasa Research and Education Hospital
NCT07134361
NCT07356648
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06697392