An interventional study of Hot-Pack and Sham Pack in Low Back Pain and Back Pain, sponsored by Erzurum Technical University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Erzurum Technical University · Not applicable, Interventional, and Treatment
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.
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.
Hot-pack (Active): Moist hot-pack at 60-65 °C applied over the lumbar region for 20 minutes with a 6-8 towel barrier. Skin is checked at minutes 5 and 10.
Sham (Comparator): Identical setup using a room-temperature pack (no heat).
Outcome Measures and Timing.
Primary: Change in pain intensity (VAS, 0-10 cm) from pre- to immediate post-intervention.
Key Secondary: Change in erector spinae stiffness (MyotonPro) from pre- to immediate post-intervention; ODI at 24-48 h; patient-reported perceived change.
Procedures. After screening and consent, baseline demographics and outcomes are recorded. MyotonPro measurements are taken over the lumbar erector spinae at L3-L4, 2-3 cm lateral, with three repeats per point and averaged. Post-session, VAS and MyotonPro are repeated; ODI and a brief perceived-change item are collected 24-48 h later. All assessments are performed by trained physiotherapists following device protocols and the Declaration of Helsinki.
Randomization, Masking, and Data Handling. Randomization is computer-assisted (1:1). Participants and assessors are blinded to group assignment via a sham procedure mirroring the active setup. Data are recorded with coded IDs and analysed with mixed-model repeated-measures ANOVA (group × time), reporting effect sizes and 95% CIs.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
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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:
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
Single-session moist hot-pack applied to the lumbar region. Pack surface temperature ≈60-65 °C; 6-8 towel layers as barrier; total duration 20 minutes. Skin checks at minutes 5 and 10. Outcomes: pain (VAS) and erector spinae stiffness (MyotonPro) immediately post-session; ODI at 24-48 h
Device: Hot-Pack · Device: Sham Pack
Single-session room-temperature pack applied to the lumbar region using the same setup as the active arm (identical towels/barrier, positioning, and timing) but without heat. Total duration 20 minutes. Outcomes measured on the same schedule. Maintains participant and assessor blinding.
Device: Hot-Pack · Device: Sham Pack
Thermal therapy delivered via a moist hot-pack applied to the lumbar area for 20 minutes. Target pack surface temp ≈60-65 °C at application; 6-8 towel layers to prevent burns; patient positioned prone or side-lying per comfort. Skin integrity checked at minutes 5 and 10; session stopped if adverse reactions occur. Single session only.
Also known as: Thermotherapy; Heat therapy
Placebo thermotherapy control using a room-temperature pack with identical preparation, towel barriers, positioning, and duration (20 minutes) as the active intervention. No heat is delivered. Used to preserve participant blinding.
Also known as: Placebo thermotherapy; Room-temperature pack
Change in Lumbar Erector Spinae Stiffness (MyotonPro, N/m) From Baseline to Immediate Post-Intervention
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.
Time frame: Baseline and immediately post-session (~20-30 minutes)
Change in Pain Intensity (VAS, 0-10) From Baseline to Immediate Post-Intervention
Pain intensity is measured on a 10-cm Visual Analogue Scale (0=no pain, 10=worst pain). The primary endpoint is the change score (Post - Baseline); negative values indicate improvement. Participants rate pain just before the session and immediately after the 20-minute intervention.
Time frame: Baseline (pre-session) and immediately post-session (~20-30 minutes after start
No study locations are listed for this record.
Plan to share: No — No plan to share individual participant data. Only aggregate findings will be reported in publications and at ClinicalTrials.gov.
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Erzurum Technical University