Chronic Non-specific Low Back Pain
Conditions
Keywords
Chronic Pain, Low back Pain, Automatic Thermo-mechanical Therapy
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.
Interventions
DEVICEAutomatic 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.
Sponsors
The City College of New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
This a double-blind sham-controlled randomized trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed