Acute Effects of Hot-Pack Therapy in Low Back Pain (NCT07242183) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Acute Effects of Hot-Pack Therapy in Low Back Pain
24 participantsStarted 2025-11-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Pregnancy
Implanted electronic devices (e.g., pacemaker)
Inability to comply with the study schedule or procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Lumbar Erector Spinae Stiffness (MyotonPro, N/m) From Baseline to Immediate Post-Intervention
Timeframe: Baseline and immediately post-session (~20-30 minutes)