Automatic Thermomechanical Massage Bed for Acute Pain Relief for Chronic Nonspecific Low Back Pain

Phase 2 RCT Automatic Thermomechanical Massage Bed for Acute Pain Relief for Chronic Nonspecific Low Back Pain

This prospective, double-blinded, sham-control, parallel-arm, randomized pilot trial will recruit n=40 participants, ages 18-65 (inclusive), with chronic low back pain (LBP) in the lower region, to be randomly assigned using 1:1 randomization method to receive a 40-minute single session of either active or sham Automated Thermo-mechanical Therapy (ATT). All research procedures, including informed consent, ATT session, and pre- and post-ATT assessments, will be completed in one single session.

Inclusion Criteria:

• Between the ages of 18 and 65
• Has had chronic non-specific lower back pain persisting for 12 weeks or more
• Conversational level of English

Exclusion Criteria:

• Contraindications to mechanical manipulation of the back
• History of back surgery within the past three years
• Recent back injury
• Presence of back implants or active implanted devices
• Low back pain resulting from other specific conditions (e.g., infection, neoplasm)
• Sensitivity to heat
• Circulatory insufficiency
• Heart disease
• Pregnant or breastfeeding
• Individuals with a history of substance use disorder
• Body weight over 298 lbs (135 kg)