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临床试验/NCT07260448
NCT07260448尚未招募不适用

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

Erzurum Technical University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年11月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
1
主要终点
Change in muscle stiffness parameters

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Change in muscle stiffness parameters

时间窗: 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.

次要结局

  • Change in pain intensity(Immediately before the intervention and within 5 minutes after completion of the 20-minute paraffin/rest session (same visit).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

esedullah akaras

Dr.

Erzurum Technical University

研究点 (1)

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