An interventional study of Automatic Thermo-mechanical Massage Bed in Chronic Non-specific Low Back Pain, sponsored by The City College of New York. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by The City College of New York · Not applicable, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →The City College of New York is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
This device delivers thermomechanical therapy to the lower back for 40 minutes
Device: Automatic Thermo-mechanical Massage Bed
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.
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
Time frame: Immediately before and immediately after intervention
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.
Time frame: 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?
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Immediately before and immediately after intervention
Plan to share: No
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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