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NCT Number: NCT07417722

Effects of Peloid Therapy in Patients With Carpal Tunnel Syndrome

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.

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Peloid Therapy

Other

Peloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions.

Wrist Splint

Device

Participants used a neutral-position wrist splint as part of conservative treatment for carpal tunnel syndrome.

Home exercise program

Other

Participants performed a standardized home exercise program including median nerve gliding exercises and tendon gliding exercises for the wrist and hand.

Primary outcomes

  1. Boston Carpal Tunnel Questionnaire (BCTQ)

    Time frame: 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 outcomes

  1. Median Nerve Cross-Sectional Area

    Time frame: 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.

  2. QuickDASH Score

    Time frame: 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.

  3. Visual Analog Scale for Pain at Rest

    Time frame: 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.

  4. Visual Analog Scale for Pain During Activity

    Time frame: 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.

  5. Visual Analog Scale for Night Pain

    Time frame: 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.

Other outcomes

  1. Short Form-12 Health Survey Scores (SF-12)

    Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), and 3-month follow-up (week 15).

    Health-related quality of life assessed using the Short Form-12 (SF-12) Health Survey. The questionnaire provides Physical Component Summary (PCS) and Mental Component Summary (MCS) scores ranging from 0 to 100. Higher scores indicate better health status and quality of life.

  2. DN4 Neuropathic Pain Questionnaire Score

    Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), and 3-month follow-up (week 15).

    Neuropathic pain evaluated using the Douleur Neuropathique 4 (DN4) questionnaire. Total score ranges from 0 to 10. Higher scores indicate greater likelihood of neuropathic pain, and scores of 4 or more suggest neuropathic pain.

  3. Hand Grip Strength

    Time frame: Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), and 3-month follow-up (week 15).

    Hand grip strength measured using a hand dynamometer and recorded in kilograms (kg). Higher values indicate greater muscle strength.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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