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.

Study Overview

• Status: Completed
• Conditions: Chronic Non-specific Low Back Pain
• Intervention / Treatment: Device: Automatic Thermo-mechanical Massage Bed

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10031
      • The Center for Discovery and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Automatic Thermomechanical Therapy; This device delivers thermomechanical therapy to the lower back for 40 minutes	Device: Automatic Thermo-mechanical Massage Bed; 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.
Sham Comparator: Sham Automatic Thermomechanical Therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland-Morris Disability Questionnaire	The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Total score can range from 0 (no disability) to 24 (severe disability). The RMDQ is scored by adding up the number of items the patient checks.	Immediately before intervention
McGill Pain Questionnaire	This questionnaire is used to evaluate a person experiencing significant pain, to monitor the pain over time and to determine the effectiveness of any intervention. The questionnaire evaluates three different domains: 1) What does the pain look like?; 2) How does your pain change with time?; 3) How strong is your pain?	Immediately before intervention and immediately after intervention
State-Trait Anxiety Inventory	This questionnaire is widely used to measure the state and trait components of anxiety	Immediately before and immediately after intervention
5-point Verbal Rating Scale for Pain Relief	Verbal rating scales about pain relief on a 5-point rating scale: none= 0, slight= 1, moderate= 2, good= 3, complete relief= 4. (Administered only at the post-ATMB intervention)28	Immediately after intervention
Modified-Modified Schöber Test	This is a physical examination used to measure the ability of a patient to flex the lower back. The patient is standing, and the examiner marks both posterior superior iliac spine (PSIS) and then draws a horizontal line at the center of both marks. A second line is marked 15 cm above the first line. The patient is then instructed to flex forward without bending the knees as if attempting to touch his/her toes, examiner re-measures the distance between the top and bottom line	Immediately before and immediately after intervention

Collaborators and Investigators

• Sponsor: The City College of New York
• Investigators: Principal Investigator: Marom Bikson, PhD, The City College of New York

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Actual): July 27, 2024
• Study Completion (Actual): July 27, 2024

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Pain; Low back Pain; Automatic Thermo-mechanical Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Acute Pain; Low Back Pain
• Other Study ID Numbers: 2024-0288-CCNY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No