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

Not Applicable

Completed

• Conditions: Chronic Non-specific Low Back Pain

• Registration Number: NCT06769321
• Lead Sponsor: The City College of New York

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-05
• Primary Completion: 2024-07-27
• Study Completion: 2024-07-27
• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The 100mm Visual Analogue Scale for Pain	Immediately before and immediately after intervention	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

Secondary Outcome Measures

Name	Time	Method
Roland-Morris Disability Questionnaire	Immediately before intervention	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.
McGill Pain Questionnaire	Immediately before intervention and immediately after intervention	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?
State-Trait Anxiety Inventory	Immediately before and immediately after intervention	This questionnaire is widely used to measure the state and trait components of anxiety
5-point Verbal Rating Scale for Pain Relief	Immediately after intervention	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
Modified-Modified Schöber Test	Immediately before and immediately after intervention	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

Trial Locations

Locations (1)

The Center for Discovery and Innovation; 🇺🇸 New York, New York, United States