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Completed

NCT Number: NCT06769321

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.

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Key information

Conditions

Chronic Non-Specific Low Back Pain Back Pain Chronic Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Center for Discovery and Innovation

New York, 10031, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. The 100mm Visual Analogue Scale for Pain

    Time frame: 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 outcomes

  1. Roland-Morris Disability Questionnaire

    Time frame: 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.

  2. McGill Pain Questionnaire

    Time frame: 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?

  3. State-Trait Anxiety Inventory

    Time frame: Immediately before and immediately after intervention

    This questionnaire is widely used to measure the state and trait components of anxiety

  4. 5-point Verbal Rating Scale for Pain Relief

    Time frame: 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

  5. Modified-Modified Schöber Test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The City College of New York

Other

Registry information

Official study title

Phase 2 RCT Automatic Thermomechanical Massage Bed for Acute Pain Relief for Chronic Nonspecific Low Back Pain

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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