Acute Effects of Hot-pack Therapy on Lumbar Erector Spinae Muscle Stiffness and Pain in Adults With Low Back Pain: A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Change in Lumbar Erector Spinae Stiffness (MyotonPro, N/m) From Baseline to Immediate Post-Intervention
研究概览
简要总结
This single-centre, parallel-group randomized controlled trial will test whether one session of moist hot-pack therapy produces immediate improvements in pain intensity and lumbar erector spinae muscle stiffness in adults with nonspecific low back pain. Participants are randomized 1:1 to hot-pack or sham (room-temperature pack). Outcomes are assessed at baseline and immediately after the session using VAS (0-10 cm) and MyotonPro; a short follow-up (24-48 h) captures Oswestry Disability Index (ODI) and perceived change. The intervention is brief, low-risk, and commonly used in clinical practice, yet high-quality evidence on its acute effects is limited.
详细描述
Rationale. Hot-pack (thermotherapy) is frequently prescribed to reduce pain and muscle tension in low back pain, but controlled evidence quantifying immediate changes in muscle mechanical properties and pain remains scarce. Demonstrating short-term benefits with objective measures (MyotonPro) and validated scales (VAS, ODI) could inform pragmatic care pathways for nonspecific low back pain.
Objectives and Hypotheses. Primary objective: determine whether a single hot-pack session reduces erector spinae stiffness (MyotonPro) and pain (VAS) versus sham. Secondary objective: explore short-term effects on functional disability (ODI) and perceived improvement. We hypothesize greater immediate reductions in stiffness and pain, and better short-term function, with hot-pack versus sham.
Design and Setting. Prospective, two-arm, parallel RCT at Atatürk University Faculty of Medicine (Physical Medicine & Rehabilitation / Orthopedics). Target sample: 30 adults (pilot). Allocation is 1:1 using computer-generated randomization; outcome assessors and participants are blinded.
Participants. Adults 18-65 y with nonspecific/mechanical low back pain and baseline VAS ≥ 3/10. Key exclusions include pregnancy, pacemaker/implanted devices, recent lumbar surgery or heat/cold therapy (<6 weeks), dermatologic lesions, neurologic deficit, tumour, or systemic inflammatory disease. Written informed consent is obtained before any procedure.
Interventions.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants receive either a heated moist pack or an identical setup with a room-temperature pack; identical towel barriers and procedures maintain participant blinding. The treating therapist cannot be blinded due to the nature of heat delivery. Outcome assessors are blinded to allocation; data are recorded with coded IDs to preserve blinding during analysis
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
- 否
入选标准
- •Adults aged 18-65 years
- •Nonspecific/mechanical low back pain (clinical diagnosis)
- •Baseline pain ≥3/10 on a 0-10 Visual Analogue Scale (VAS)
- •Able to understand procedures and provide written informed consent
- •Able to attend baseline, immediate post-session, and 24-48 h follow-up assessments
排除标准
- •Neurologic deficit, tumour, or systemic inflammatory disease
- •Prior lumbar spine surgery
- •Heat or cold therapy to the lumbar region within the past 6 weeks
- •Dermatologic lesions, open wounds, or skin conditions over the lumbar area
- •Contraindications to heat (e.g., impaired sensation/neuropathy over the area, severe circulatory disorders)
- •Implanted electronic devices (e.g., pacemaker)
- •Inability to comply with the study schedule or procedures
结局指标
主要结局
Change in Lumbar Erector Spinae Stiffness (MyotonPro, N/m) From Baseline to Immediate Post-Intervention
时间窗: Baseline and immediately post-session (~20-30 minutes)
Myotonometric stiffness (N/m) is captured over lumbar erector spinae (L3-L4 level, \~2-3 cm lateral). Three taps per point; averaged. Endpoint is change score (Post - Baseline); negative values indicate reduced stiffness.
次要结局
- Change in Pain Intensity (VAS, 0-10) From Baseline to Immediate Post-Intervention(Baseline (pre-session) and immediately post-session (~20-30 minutes after start)
研究者
esedullah akaras
Dr.
Erzurum Technical University