Effects of Peloid Therapy in Patients With Carpal Tunnel Syndrome

NCT07417722 | Completed

• 1 other identifier: 515
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Carpal Tunnel Syndrome; Peloidotherapy; Median Nerve Cross-Sectional Area; Hand Grip Strength; Functional Disability; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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).

• QuickDASH Score

  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

  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

  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

  Baseline (week 0), end of treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)

Other Outcomes (3)

• Short Form-12 Health Survey Scores (SF-12)

  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

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

• Hand Grip Strength

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

Study Arms (2)

Non-Peloid Therapy Group

ACTIVE COMPARATOR

Participants receive treatment consisting of wrist splinting and a structured home exercise program. No peloid therapy is administered.

Device: Wrist Splint; Other: Home Exercise Program

Peloid Therapy Group

EXPERIMENTAL

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.

Other: Peloid Therapy; Device: Wrist Splint; Other: Home Exercise Program

Interventions

Peloid Therapy OTHER

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

Peloid Therapy Group

Wrist Splint DEVICE

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

Non-Peloid Therapy Group; Peloid Therapy Group

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.

Non-Peloid Therapy Group; Peloid Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 29892976 BACKGROUND

• 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.

  PMID: 37906312 BACKGROUND

• 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.

  PMID: 28210859 BACKGROUND

• 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.

  PMID: 40358708 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain

Interventions

Mud Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor was blinded to group allocation. No other participants or study personnel were masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician in Physical Medicine and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 18, 2026
• Study Start: June 1, 2025
• Primary Completion: September 11, 2025
• Study Completion: January 15, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)