CompletedNot Applicable

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

United States40 participantsStarted 2024-06-05

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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: * 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)

What they're measuring

The 100mm Visual Analogue Scale for Pain

Timeframe: Immediately before and immediately after intervention

Trial details

NCT IDNCT06769321

SponsorThe City College of New York

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-27

View on ClinicalTrials.gov More Chronic Non-specific Low Back Pain trials