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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Peloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions.
Participants used a neutral-position wrist splint as part of conservative treatment for carpal tunnel syndrome.
Participants performed a standardized home exercise program including median nerve gliding exercises and tendon gliding exercises for the wrist and hand.
Gaziosmanpaşa Training and Research Hospital
Istanbul, Turkey (Türkiye)
Boston Carpal Tunnel Questionnaire (BCTQ)
Symptom severity and functional status measured using the Boston Carpal Tunnel Questionnaire (BCTQ), which includes Symptom Severity and Functional Status subscales. Each item is scored from 1 to 5 and subscale scores are calculated as the mean of item scores. Higher scores indicate worse symptoms and functional limitation.
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Median Nerve Cross-Sectional Area
Median nerve cross-sectional area was measured using ultrasonography.
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), and 3-month follow-up (week 15).
QuickDASH Score
Upper extremity disability measured using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Visual Analog Scale for Pain at Rest
Pain intensity at rest measured using the Visual Analog Scale (VAS), scored from 0 to 10. Higher scores indicate worse pain.
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Visual Analog Scale for Pain During Activity
Pain intensity during activity measured using the Visual Analog Scale (VAS), scored from 0 to 10. Higher scores indicate worse pain.
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Visual Analog Scale for Night Pain
Night pain intensity measured using the Visual Analog Scale (VAS), scored from 0 to 10. Higher scores indicate worse pain.
Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
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