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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Automatic Thermomechanical Therapy | Experimental | This device delivers thermomechanical therapy to the lower back for 40 minutes |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marom Bikson, PhD | The City College of New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Discovery and Innovation | New York | New York | 10031 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41585325 | Derived | 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. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This a double-blind sham-controlled randomized trial.
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|
| 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 |
| D001416 | Back Pain |