Carpal Tunnel Syndrome (CTS)
Conditions
Keywords
Carpal Tunnel Syndrome, Peloidotherapy, Median Nerve Cross-Sectional Area, Hand Grip Strength, Functional Disability, Pain
Brief summary
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.
Detailed description
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.
Interventions
OTHERPeloid Therapy
Peloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions.
DEVICEWrist Splint
Participants used a neutral-position wrist splint as part of conservative treatment for carpal tunnel syndrome.
OTHERHome Exercise Program
Participants performed a standardized home exercise program including median nerve gliding exercises and tendon gliding exercises for the wrist and hand.
Sponsors
Gaziosmanpasa Research and Education Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor was blinded to group allocation. No other participants or study personnel were masked.
Intervention model description
Participants were randomly assigned to one of two parallel groups. One group received a wrist splint and a home exercise program, while the other group received peloidotherapy in addition to the same wrist splint and home exercise program. Participants remained in their assigned group throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with mild or mild-to-moderate carpal tunnel syndrome confirmed by electromyography (EMG) * Presence of clinical symptoms for at least 3 months * Age 18 years and older * No limitation in wrist joint range of motion
Exclusion criteria
* Cervical radiculopathy * Polyneuropathy * Pregnancy * Presence of underlying metabolic diseases (diabetes mellitus, inflammatory rheumatic diseases, thyroid disorders) * Presence of hand osteoarthritis * Previous wrist or hand surgery * Severe carpal tunnel syndrome confirmed by electromyography (EMG) * Thenar muscle atrophy * Corticosteroid injection for carpal tunnel syndrome or use of a wrist splint within the last 6 months * History of malignancy * Receipt of peloid therapy or any physical therapy modality for carpal tunnel syndrome within the last 6 months * Contraindications to peloid therapy (impaired skin integrity or active infection at the application site)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Carpal Tunnel Questionnaire (BCTQ) | Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Nerve Cross-Sectional Area | Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), and 3-month follow-up (week 15). | Median nerve cross-sectional area was measured using ultrasonography. |
| QuickDASH Score | Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15) | 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. |
| Visual Analog Scale for Pain at Rest | Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15) | Pain intensity at rest measured using the Visual Analog Scale (VAS), scored from 0 to 10. Higher scores indicate worse pain. |
| Visual Analog Scale for Pain During Activity | Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15) | Pain intensity during activity measured using the Visual Analog Scale (VAS), scored from 0 to 10. Higher scores indicate worse pain. |
| Visual Analog Scale for Night Pain | Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15) | Night pain intensity measured using the Visual Analog Scale (VAS), scored from 0 to 10. Higher scores indicate worse pain. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATOREbru Yılmaz Yalçınkaya, MD
Department of Physical Medicine and Rehabilitation, Gaziosmanpaşa Training and Research Hospital, Istanbul, Turkey
PRINCIPAL_INVESTIGATORSerap Seringeç Karabulut, MD
Department of Medical Ecology and Hydroclimatology, Gaziosmanpaşa Training and Research Hospital, Istanbul, Turkey
Outcome results
None listed