Effects of Peloid Therapy in Patients With Carpal Tunnel Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome (CTS)
• Intervention / Treatment: Device: Wrist Splint; Other: Home Exercise Program; Other: Peloid Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Gaziosmanpaşa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-Peloid Therapy Group; Participants receive treatment consisting of wrist splinting and a structured home exercise program. No peloid therapy is administered.	Device: Wrist Splint; Participants used a neutral-position wrist splint as part of conservative treatment for carpal tunnel syndrome.; Other: Home Exercise Program; Participants performed a standardized home exercise program including median nerve gliding exercises and tendon gliding exercises for the wrist and hand.
Experimental: Peloid Therapy Group; Participants receive wrist splinting and a structured home exercise program in addition to peloid therapy. Peloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions.	Device: Wrist Splint; Participants used a neutral-position wrist splint as part of conservative treatment for carpal tunnel syndrome.; Other: Home Exercise Program; Participants performed a standardized home exercise program including median nerve gliding exercises and tendon gliding exercises for the wrist and hand.; Other: Peloid Therapy; Peloid therapy is applied at 45 °C for 30 minutes per session, for a total of 15 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Nerve Cross-Sectional Area	Median nerve cross-sectional area was measured using ultrasonography.	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.	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.	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.	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.	Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form-12 Health Survey Scores (SF-12)	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.	Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), and 3-month follow-up (week 15).
DN4 Neuropathic Pain Questionnaire Score	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.	Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), and 3-month follow-up (week 15).
Hand Grip Strength	Hand grip strength measured using a hand dynamometer and recorded in kilograms (kg). Higher values indicate greater muscle strength.	Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), and 3-month follow-up (week 15).

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Principal Investigator: Ebru Yılmaz Yalçınkaya, MD, Department of Physical Medicine and Rehabilitation, Gaziosmanpaşa Training and Research Hospital, Istanbul, Turkey; Principal Investigator: Serap Seringeç Karabulut, MD, Department of Medical Ecology and Hydroclimatology, Gaziosmanpaşa Training and Research Hospital, Istanbul, Turkey

Publications and helpful links

General Publications

• Yigit F, Ordahan B. Effects of high-intensity laser therapy on pain, functional status, hand grip strength, and median nerve cross-sectional area by ultrasonography in patients with carpal tunnel syndrome. Lasers Med Sci. 2023 Oct 31;38(1):248. doi: 10.1007/s10103-023-03913-z.
• Tezcan S, Ulu Ozturk F, Uslu N, Nalbant M, Umit Yemisci O. Carpal Tunnel Syndrome: Evaluation of the Effects of Low-Level Laser Therapy With Ultrasound Strain Imaging. J Ultrasound Med. 2019 Jan;38(1):113-122. doi: 10.1002/jum.14669. Epub 2018 Jun 11.
• Metin Okmen B, Kasapoglu Aksoy M, Gunes A, Eroksuz R, Altan L. Effectiveness of PELOID therapy in carpal tunnel syndrome: A randomized controlled single blind study. Int J Biometeorol. 2017 Aug;61(8):1403-1410. doi: 10.1007/s00484-017-1317-1. Epub 2017 Feb 16.
• Sirin Ahisha B, Akkaya Ari S, Paker N, Kesiktas N, Barut Y. Comparison of the efficacy of peloid therapy and paraffin treatment in carpal tunnel syndrome. Int J Biometeorol. 2025 Aug;69(8):1957-1967. doi: 10.1007/s00484-025-02941-4. Epub 2025 May 13.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): September 11, 2025
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Carpal Tunnel Syndrome; Hand Grip Strength; Peloidotherapy; Functional Disability; Median Nerve Cross-Sectional Area
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Carpal Tunnel Syndrome; Therapeutics; Balneology; Mud Therapy
• Other Study ID Numbers: 515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to ethical and legal restrictions related to patient confidentiality and institutional policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No