Immediate Effects of Paraffin Wax Therapy on Forearm and Hand Muscle Stiffness and Pain in Carpal Tunnel Syndrome

NCT ID: NCT07260448

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-25
• Study Completion Date: 2025-12-06

Brief Summary

This randomized controlled trial aims to investigate the immediate effects of paraffin wax therapy on muscle stiffness and pain among patients diagnosed with Carpal Tunnel Syndrome (CTS). The intervention involves immersing the hand and forearm in paraffin wax at 42-44 °C for 20 minutes. Stiffness will be measured using the MyotonPro device, and pain will be evaluated using standard visual scales.

Detailed Description

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper limb and may alter the passive mechanical properties of forearm and hand muscles, contributing to pain and functional limitation. Handheld devices such as MyotonPro allow non-invasive, point-of-care assessment of muscle stiffness, elasticity and viscoelastic behaviour in clinical settings. Paraffin wax therapy is widely used as a superficial heat modality in hand rehabilitation and has been shown to reduce pain and improve function in various hand conditions, but its immediate effects on objectively measured muscle stiffness in CTS remain unclear. This parallel-group randomised controlled trial will examine the immediate effects of a single paraffin wax session on muscle stiffness and pain in adults with CTS. Physically active adults aged 18-65 years with clinically diagnosed CTS will be recruited from university-based facilities in Erzurum, Türkiye, and randomly allocated (1:1) to paraffin wax therapy or a control condition. A priori power analysis indicated that a total sample of 24 participants (12 per group) would provide adequate power to detect between-group differences in pre- to post-intervention change. Mechanical properties of selected forearm and hand muscles (e.g. APB, FDS, ECRB, FCU) will be assessed using MyotonPro immediately before and after the intervention. In the intervention group, the affected hand and forearm will receive 20 minutes of paraffin wax therapy at approximately 42-44 °C using a standardised brush-on technique and safety checks for skin integrity and temperature. Pain intensity in the affected region will be recorded pre- and post-session using a validated numeric rating or similar pain scale. The primary outcome is the between-group difference in immediate change in MyotonPro stiffness parameters, with secondary outcomes including change in pain and exploratory relationships between changes in stiffness and pain. Mixed model repeated measures ANOVA will be used to compare pre- to post-intervention changes between groups. Findings from this study may help clarify the short-term neuromuscular and symptomatic effects of paraffin wax therapy in CTS and inform future rehabilitation protocols.

Conditions

Carpal Tunnel Syndrome (CTS); Muscle Stiffness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paraffin Wax Therapy

Participants receive a single session of paraffin wax therapy to the affected hand and forearm. Muscle stiffness and pain are assessed immediately before and after the session.

Group Type: EXPERIMENTAL

Paraffin Wax Therapy

Intervention Type: OTHER

Participants in the experimental arm receive paraffin wax therapy to the affected hand and forearm. Melted paraffin is maintained at approximately 42-44 °C. Using a brush-on technique, 10 consecutive layers of wax are applied, and the limb is then covered with a plastic glove and towel to retain heat. The participant remains seated with the forearm supported in a relaxed position for 20 minutes. Muscle stiffness (MyotonPro) and pain are measured immediately before and within 5 minutes after the session.

Rest Period (No Treatment)

Intervention Type: OTHER

Participants in the control arm rest quietly for 20 minutes in a comfortable seated or supine position with the forearm supported. No thermal, manual or exercise-based treatment is provided during this period. Muscle stiffness (MyotonPro) and pain are measured immediately before and within 5 minutes after the rest period, using the same procedures and time points as in the experimental arm.

Rest / Control

Participants rest quietly for 20 minutes in a comfortable position with the forearm supported, without receiving paraffin wax or any other physical/thermal modality. Muscle stiffness and pain are assessed at the same time points as in the experimental arm.

Group Type: OTHER

Paraffin Wax Therapy

Intervention Type: OTHER

Participants in the experimental arm receive paraffin wax therapy to the affected hand and forearm. Melted paraffin is maintained at approximately 42-44 °C. Using a brush-on technique, 10 consecutive layers of wax are applied, and the limb is then covered with a plastic glove and towel to retain heat. The participant remains seated with the forearm supported in a relaxed position for 20 minutes. Muscle stiffness (MyotonPro) and pain are measured immediately before and within 5 minutes after the session.

Rest Period (No Treatment)

Intervention Type: OTHER

Participants in the control arm rest quietly for 20 minutes in a comfortable seated or supine position with the forearm supported. No thermal, manual or exercise-based treatment is provided during this period. Muscle stiffness (MyotonPro) and pain are measured immediately before and within 5 minutes after the rest period, using the same procedures and time points as in the experimental arm.

Interventions

Paraffin Wax Therapy

Participants in the experimental arm receive paraffin wax therapy to the affected hand and forearm. Melted paraffin is maintained at approximately 42-44 °C. Using a brush-on technique, 10 consecutive layers of wax are applied, and the limb is then covered with a plastic glove and towel to retain heat. The participant remains seated with the forearm supported in a relaxed position for 20 minutes. Muscle stiffness (MyotonPro) and pain are measured immediately before and within 5 minutes after the session.

Intervention Type: OTHER

Rest Period (No Treatment)

Participants in the control arm rest quietly for 20 minutes in a comfortable seated or supine position with the forearm supported. No thermal, manual or exercise-based treatment is provided during this period. Muscle stiffness (MyotonPro) and pain are measured immediately before and within 5 minutes after the rest period, using the same procedures and time points as in the experimental arm.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinically diagnosed carpal tunnel syndrome.
• Age between 18 and 65 years.
• Apparently healthy, without a known chronic systemic disease (other than CTS).
• No history of other chronic musculoskeletal or neurological disorders.

Exclusion Criteria

• Previous surgery on the affected wrist or hand.
• Systemic conditions affecting nerve function (e.g., diabetes mellitus, thyroid disease)
• Cardiovascular disease or uncontrolled hypertension.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amasya University

OTHER

Sponsor Role: collaborator

Bangor University

OTHER

Sponsor Role: collaborator

Erzurum Technical University

OTHER

Sponsor Role: lead

Responsible Party

esedullah akaras

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erzurum Şehir Hastanesi

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Esedullah Akaras, Dr.

Role: CONTACT

esedullah.akaras@erzurum.edu.tr

4445388 ext. 2772

Facility Contacts

Aliekber TAYFUN, Dr.

Role: primary

aliekbertayfun@gmail.com

0 (442) 432 10 10

Other Identifiers

ETU-P-WAX-CTS Trial

Identifier Type: -

Identifier Source: org_study_id