Efficacy of Paraffin Bath and Peloidotherapy in Carpal Tunnel Syndrome

NCT06986668 | Enrolling By Invitation

• 1 other identifier: KonyaBeyhekimTRH9188
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Patients diagnosed with mild and moderate idiopathic CTS will be randomly divided into three groups. Patients who received 15 sessions of peloid therapy along with a home exercise program will constitute the first group. The second group will consist of patients who receive 15 sessions of paraffin bath and a home exercise program. Patients who were given only a home exercise program will be included in the third group. "Patients will be evaluated in detail in terms of clinical examination and outcomes three weeks after the end of treatment and again at three months.

Conditions

Carpal Tunnel Syndrome (CTS); Peloidotherapy; Paraffin Bath; Exercise

Keywords

carpal tunnel syndrome (CTS); Peloidotherapy; paraffin bath; exercise; ultrasound; pain

Outcome Measures

Primary Outcomes (2)

• VAS pain

  A 10 cm long line is drawn, this line is divided into 10 intervals of 10 mm width, 0: no pain and 10: the most severe pain is explained, and the patient is asked to mark the value corresponding to the resting pain and the pain during movement on the scale.

  baseline, week 3 and week 12

• The Boston Carpal Tunnel Syndrome Questionnaire

  The Turkish version of the Boston Carpal Tunnel Questionnaire score. It is used to evaluate the symptom severity and functionality of the patients. BCTQ is a questionnaire consisting of 2 parts: symptom severity scale (SSS) and functional status scale (FSS). Each item in both sections has 5 different answers that score between 1 and 5. The mean score is obtained by dividing the total score by the number of questions and ranges from 1 to 5, with a higher score indicating severe symptom.

  baseline, week 3 and week 12

Secondary Outcomes (5)

• Hand grip strength

  baseline, week 3 and week 12

• Finger pinch strength

  baseline, week 3 and week 12

• Douleur Neuropathique 4

  baseline, week 3 and week 12

• Quick DASH Score

  baseline, week 3 and week 12

• Ultrasonographic evaluation of the median nerve

  baseline, week 3 and week 12

Study Arms (3)

Peloidotherapy

EXPERIMENTAL

This group will consist of patients who have received peloid therapy for a total of 15 sessions of 20 minutes at 45 degrees for 3 weeks, 5 days a week, along with a home exercise program.

Other: Peloidotherapy; Other: home exersize

paraffin bath

EXPERIMENTAL

This group will consist of patients who have received paraffin bath for a total of 15 sessions of 20 minutes for 3 weeks, 5 days a week, along with a home exercise program.

Other: paraffin bath; Other: home exersize

Home exercise

EXPERIMENTAL

This group will consist of patients who have only been given a home exercise program. Flexor tendon gliding exercises, median nerve gliding exercises, and isometric wrist strengthening exercises will be given as exercises.

Other: home exersize

Interventions

Peloidotherapy OTHER

Peloidotherapy stands out among superficial heating physical therapy modalities with its mineral and natural origin.

Peloidotherapy

paraffin bath OTHER

It is an effective treatment for the treatment of patients' hands, arms and feet by applying the brushing method to different body parts, relieving pain and improving function, thus providing freedom of life.

paraffin bath

home exersize OTHER

Flexor tendon gliding exercises, median nerve gliding exercises, and isometric wrist strengthening exercises will be given as exercises.

Home exercise; Peloidotherapy; paraffin bath

Eligibility Criteria

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

You may qualify if:

• Being between the ages of 18-65
• Agreeing to participate voluntarily in the study
• Being diagnosed with mild or moderate idiopathic chronic CTS as a result of anamnesis, clinical examination and nerve conduction study

You may not qualify if:

• Presence of predisposing etiological factors for CTS such as diabetes mellitus, chronic kidney and liver disease, acromegaly, rheumatological diseases, acute trauma, hypothyroidism, etc.
• Being diagnosed with severe CTS
• Having a history of previous wrist surgery or trauma
• Having atrophy in the thenar region or weakness in the thenar muscles
• Having cervical radiculopathy, thoracic outlet syndrome, polyneuropathy, brachial neuropathy or proximal median nerve neuropathy
• Having had steroid injections in the last 3 months and taking oral steroid medications
• Being pregnant
• Having an open wound or rash in the wrist and its surroundings that would prevent treatment
• Patients who are receiving or will receive another/additional treatment for CTS
• Patients with a bifid median nerve, persistent median artery, ganglion cyst, tenosynovitis, or tendinitis in the wrist.

Sponsors & Collaborators

• Konya Beyhekim Training and Research Hospital: lead

Study Sites (1)

Konya Beyhekim Training and Research Hospital

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Motor Activity; Pain

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; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: single-blind, randomized, prospective

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: May 25, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)