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NCT Number: NCT07260448

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Paraffin Wax Therapy

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)

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.

Primary outcomes

  1. Change in muscle stiffness parameters

    Time frame: Immediately before the intervention and within 5 minutes after completion of the 20-minute paraffin/rest session (same visit)

    Change in MyotonPro-derived muscle stiffness (Newton per metre) of selected forearm and hand muscles (adductor pollicis brevis, flexor digitorum superficialis, extensor carpi radialis brevis, flexor carpi ulnaris ). For each site, three consecutive impulses separated by at least 10 seconds will be averaged. The primary comparison is the between-group difference (paraffin vs rest) in pre- to post-session change scores.

Secondary outcomes

  1. Change in pain intensity

    Time frame: Immediately before the intervention and within 5 minutes after completion of the 20-minute paraffin/rest session (same visit).

    Change in self-reported pain intensity in the affected hand/forearm, assessed using a numeric rating scale (0 = no pain, 10 = worst imaginable pain). The main comparison is between-group difference in pre- to post-session change scores. Pain assessments are performed at the same time points as MyotonPro measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Esedullah Akaras, Dr.

CONTACT

[email protected]

4445388 ext. 2772

Sponsors and collaborators

Lead sponsor

Erzurum Technical University

Other

Collaborators

  • Amasya University
  • Bangor University

Registry information

Official study title

Immediate Effects of Paraffin Wax Therapy on the Forearm and Hand Muscles' Stiffness and Pain in Patients With Carpal Tunnel Syndrome: A Randomised Controlled Trial

Acronym: Paraffin-CTS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

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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