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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Erzurum Technical University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in muscle stiffness parameters
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Paraffin Wax Therapy (Other)
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.
Intervention: Rest Period (No Treatment) (Other)
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.
Intervention: Paraffin Wax Therapy (Other)
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.
Intervention: Rest Period (No Treatment) (Other)
Outcomes
Primary Outcomes
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
- Change in pain intensity(Immediately before the intervention and within 5 minutes after completion of the 20-minute paraffin/rest session (same visit).)
Investigators
esedullah akaras
Dr.
Erzurum Technical University