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

NCT06769321 | Completed FDA Device

• 1 other identifier: 2024-0288-CCNY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Non-specific Low Back Pain

Keywords

Chronic Pain; Low back Pain; Automatic Thermo-mechanical Therapy

Outcome Measures

Primary Outcomes (1)

• The 100mm Visual Analogue Scale for Pain

  The VAS-P100 is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients. The 100-mm VAS-P is a straight horizontal line of fixed length of 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst). The participant marks on the line the point that they feel represents their perception of their current state. The score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks

  Immediately before and immediately after intervention

Secondary Outcomes (5)

• Roland-Morris Disability Questionnaire

  Immediately before intervention

• McGill Pain Questionnaire

  Immediately before intervention and immediately after intervention

• State-Trait Anxiety Inventory

  Immediately before and immediately after intervention

• 5-point Verbal Rating Scale for Pain Relief

  Immediately after intervention

• Modified-Modified Schöber Test

  Immediately before and immediately after intervention

Study Arms (2)

Active Automatic Thermomechanical Therapy

EXPERIMENTAL

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

Device: Automatic Thermo-mechanical Massage Bed

Sham Automatic Thermomechanical Therapy

SHAM COMPARATOR

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.

Device: Automatic Thermo-mechanical Massage Bed

Interventions

Automatic Thermo-mechanical Massage Bed DEVICE

The MASTER V6 (Master series, CGM MB-1701, CERAGEM Co. Ltd., Cheonan, Korea) used in this study is a commercially available automated thermo-mechanical therapy device that combines mechanical spinal stimulation with far-infrared (FIR) heat treatment.

Active Automatic Thermomechanical Therapy; Sham Automatic Thermomechanical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The City College of New York: lead

Study Sites (1)

The Center for Discovery and Innovation

New York, New York, 10031, United States

Location

Related Publications (1)

• Donnery K, Pilloni G, FallahRad M, Lee K, Han B, Park S, Kim J, Charvet L, Bikson M. Automated thermo-mechanical therapy for immediate relief in chronic non-specific lower back pain: a randomized controlled trial. Front Neuroergon. 2026 Jan 9;6:1674928. doi: 10.3389/fnrgo.2025.1674928. eCollection 2025.

  PMID: 41585325 DERIVED

MeSH Terms

Conditions

Chronic Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Officials

• Marom Bikson, PhD

  The City College of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This a double-blind sham-controlled randomized trial.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: June 5, 2024
• Primary Completion: July 27, 2024
• Study Completion: July 27, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)