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

The City College of New York

Status: Completed

Conditions: Chronic Non-specific Low Back Pain

Treatments: Device: Automatic Thermo-mechanical Massage Bed

Study type: Interventional

Funder types: Other

Identifiers

NCT06769321

2024-0288-CCNY

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Active Automatic Thermomechanical Therapy

Experimental group

Description:

This device delivers thermomechanical therapy to the lower back for 40 minutes

Treatment:

Device: Automatic Thermo-mechanical Massage Bed

Sham Automatic Thermomechanical Therapy

Sham Comparator group

Description:

The comparator device is a sham device that has the same outer appearance as the investigational device. Throughout the entire massage session, the intensity will be set to a level below 1, in areas unrelated to where the major muscles causing lower back pain are located, minimizing the actual massage effect. The thermal component will be turned off entirely.

Treatment:

Device: Automatic Thermo-mechanical Massage Bed