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Studies

Interventional Not yet recruiting

NCT07242183 on ClinicalTrials.gov

Acute Effects of Hot-Pack Therapy in Low Back Pain

Official title: Acute Effects of Hot-pack Therapy on Lumbar Erector Spinae Muscle Stiffness and Pain in Adults With Low Back Pain: A Randomised Controlled Trial.

  • Sponsor: Erzurum Technical University
  • Collaborators: Amasya University, Ataturk University
  • Enrollment: 24 (Estimated)
  • Study start: 2025-11-10 (Estimated)
  • Primary completion: 2025-12-30 (Estimated)
  • Study completion: 2025-12-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Two-arm, single-session randomized controlled trial comparing moist hot-pack versus sham (room-temperature pack) in adults with nonspecific low back pain. Participants are randomized 1:1; treating therapist is not blinded, while participants and outcomes assessors are blinded. Outcomes: pain (VAS) and lumbar erector spinae stiffness (MyotonPro) immediately post-session; ODI at 24-48 h.
  • Masking: Double (Participant, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Low Back Pain
  • Back Pain

Intervention / Treatment

  • Device: Hot-Pack
  • Device: Sham Pack

Primary Outcome Measures

  • Change in Lumbar Erector Spinae Stiffness (MyotonPro, N/m) From Baseline to Immediate Post-Intervention (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.

Study Officials

  • Gökhan YAÄžIZ, Dr. (Study Chair) — Amasya University
  • Julian OWEN, Dr. (Study Director) — Bangor University