Low Back Pain
Conditions
Brief summary
The purpose of this study is to determine whether the Erchonia® ML Scanner (MLS) is effective in the treatment of acute minor episodic chronic low back pain of musculoskeletal origin.
Detailed description
Back pain is a common musculoskeletal disorder affecting 80% of people at some point in their lives. It is the second most common neurological ailment in the United States, second only to headache, and it is the most common cause of job-related disability and a leading contributor to missed work. Around $50 billion is spent in the U.S. each year to treat low back pain. Men and women are equally affected, with the most common age affected being between 30 and 50 years. Most low back pain stems from benign musculoskeletal problems, referred to as non-specific low back pain, which is the etiology being evaluated in this study. It is caused by lumbar sprain or strain a stretch injury to the ligaments, tendons, and/or muscles of the low back. Current mainstream treatment approaches for low back pain due to lumbar sprain strain focus on reducing pain and inflammation, including rest; oral and topical over-the-counter and prescription medications; local heat applications; massage and exercise. Alternative treatment options include acupuncture; chiropractic manipulation; biofeedback; traction; transcutaneous electrical nerve stimulation (TENS); and ultrasound. Surgical procedures are also a treatment option for low back pain, and although the outcomes are often poor and do not last, back surgery remains the 3rd most common form of surgery in the United States, with about 300,000 back surgeries performed annually. Low Level Laser Therapy (LLLT) communicates information to the receptors on the membrane of the cell and mitochondrion (the enzymatic engine of the cell). This energetic information reaches the cell's DNA, which directly controls cell function. When the cells receive better information, they work better, as do the tissues they comprise, like bones, cartilage, tendons, ligaments, etc. In this way, LLLT promotes the healing and regeneration of damaged tissues, having both local effects on tissue function and also systemic effects carried throughout the body by the blood and acupuncture meridians. The key basic physiological effects of low level laser light include increased cell membrane polarization and permeability; Adenosine-5-triphosphate (ATP) production and respiratory chain activity; enzyme activity; collagen and epithelial production; capillary formation; macrophage (immune) activity; analgesic effects due to elevated endorphin production, electrolytic nerve blockage, and improved blood and lymph flow; anti-inflammatory effect due to improved circulation and accelerated tissue regeneration; and increased production of antioxidants. Of additional benefit is that light energy from low level lasers will only be absorbed by cells and tissues that are not functioning normally and has no effect on healthy cells. Therefore, low level laser therapy has the potential benefit of providing an effective means of reducing low back pain that is simple, quick, non-invasive and side-effect free.
Interventions
DEVICEErchonia MLS
The Erchonia® MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
DEVICEPlacebo Laser
The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
Sponsors
Erchonia Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary pain is in the lower back * Low back pain is of musculoskeletal origin stemming from benign musculoskeletal problems wherein the etiology is lumbar sprain or strain * Diagnosis based on review of patient history, physical examination, medication use history and review of prior medical records * Low back pain is episodic chronic, having occurred and recurred over regular or irregular intervals of time over at least the last 3 months * Degree of Pain rating on the visual analog scale (VAS) is 40 or greater * Subject is willing and able to refrain from taking non study medications and herbal supplements for the relief of pain or inflammation including muscle relaxants throughout study participation * Subject is willing and able to refrain from non study procedure therapies for the management of low back pain throughout study participation * Primary language is English
Exclusion criteria
* Low back pain is undiagnosed or has been diagnosed as being other than of benign musculoskeletal origin wherein the etiology is lumbar sprain or strain * Low back pain has been diagnosed or cannot be satisfactorily ruled out as being in whole or in part due to one or more of the following origins - mechanical, inflammatory, neoplastic, metabolic origin, psychosomatic * Tension myositis syndrome * Known herniated disc injury * Osteoporosis with compression fractures * Congenital deformity of spine * Current active chronic pain disease * Cancer or cancer treatment in the past 6 months * Use of the following analgesics within 7 days of study onset - paracetamol, acetominophen, non-steroidal anti-inflammatory drugs (NSAIDs), compound analgesics, topical analgesics * Use of the following muscle relaxants within the prior 30 days of study onset - cyclobenzaprine, diazepam, meprobamate * Use of the following muscle relaxants within 7 days of study onset - carisoprodol, Metaxalone * Use of the following antidepressants within 30 days of study onset if consumption has commenced within that 30 day period - duloxetine, amitriptyline, imipramine, clomipramine, nortriptyline, desipramine, selective serotonin reuptake inhibitors (SSRIs) * Systemic corticosteroid therapy or narcotics taken within 30 days (inhaled and topical corticosteroids okay) of study onset * Local or epidural injection of corticosteroids within 3 months of study onset * Botulinum toxin injection for chronic low back pain within 4 months of study onset * Active infection, wound, other external trauma to the treatment area * Surgery to the lower back or spine in the past 12 months * Medical, physical or other contraindications for, or sensitivity to, light therapy * Pregnant, breast feeding or planning pregnancy prior to study end * Serious mental health illness such as dementia or schizophrenia or psychiatric hospitalization in past 2 years * Developmental disability or cognitive impairment that precludes adequate comprehension of consent form or the ability to record study measurements * Participation in other research in the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Proportion of Primary Outcome Successes Between Treatment Groups | 4 Months | Primary outcome success for an individual subject was defined as a 30% or greater change (decrease) in VAS pain score at 4 months post-procedure relative to baseline. The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score indicates a greater level of pain, and a lower score indicates a lower level of pain. A negative (-) percent change in VAS rating indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success was defined as a 35% or greater difference in the proportion of individual primary outcome successes in each treatment group, in favor of the active treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Low Back Pain Visual Analog Scale (VAS) Score | Baseline and 4 Months | The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score on the VAS indicates a greater level of pain, and a lower score indicates a lower level of pain.A decrease in the VAS pain rating indicates a reduction in low back pain and is positive for study success. An increase in the VAS pain rating indicates a worsening of low back pain and is negative for study success. The mean change in low back pain score recorded on the Visual Analog Scale (VAS) from baseline to 4 months post-procedure was calculated for each treatment group. |
| Satisfaction With Study Outcome | 4 Months | At study endpoint, the subject was asked to rate how satisfied he or she was with any overall change in low back pain attained following the procedure administration phase with the Erchonia MLS Laser, using the following five-point scale: Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erchonia MLS The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week. | 31 |
| Placebo Laser The Placebo Laser has the same appearance and treatment application as the Erchonia MLS but does not emit any therapeutic light. | 31 |
| Total | 62 |
Baseline characteristics
| Characteristic | Erchonia MLS | Placebo Laser | Total |
|---|---|---|---|
| Age, Continuous | 53.90 years STANDARD_DEVIATION 12.62 | 49.48 years STANDARD_DEVIATION 16.39 | 51.69 years STANDARD_DEVIATION 14.68 |
| Duration of Low Back Pain | 92.65 months STANDARD_DEVIATION 95.42 | 93.45 months STANDARD_DEVIATION 110.86 | 93.05 months STANDARD_DEVIATION 102.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 27 Participants | 57 Participants |
| Region of Enrollment United States | 31 participants | 31 participants | 62 participants |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Male | 15 Participants | 18 Participants | 33 Participants |
| Visual Analog Scale (VAS) Degree of Low Back Pain Rating | 61.19 units on a scale STANDARD_DEVIATION 13.24 | 55.94 units on a scale STANDARD_DEVIATION 10.74 | 58.56 units on a scale STANDARD_DEVIATION 12.35 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
Primary
Difference in the Proportion of Primary Outcome Successes Between Treatment Groups
Primary outcome success for an individual subject was defined as a 30% or greater change (decrease) in VAS pain score at 4 months post-procedure relative to baseline. The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score indicates a greater level of pain, and a lower score indicates a lower level of pain. A negative (-) percent change in VAS rating indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success was defined as a 35% or greater difference in the proportion of individual primary outcome successes in each treatment group, in favor of the active treatment group.
Time frame: 4 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erchonia MLS | Difference in the Proportion of Primary Outcome Successes Between Treatment Groups | 27 participants |
| Placebo Laser | Difference in the Proportion of Primary Outcome Successes Between Treatment Groups | 9 participants |
p-value: <0.00001t-test, 2 sided
Secondary
Change in Low Back Pain Visual Analog Scale (VAS) Score
The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score on the VAS indicates a greater level of pain, and a lower score indicates a lower level of pain.A decrease in the VAS pain rating indicates a reduction in low back pain and is positive for study success. An increase in the VAS pain rating indicates a worsening of low back pain and is negative for study success. The mean change in low back pain score recorded on the Visual Analog Scale (VAS) from baseline to 4 months post-procedure was calculated for each treatment group.
Time frame: Baseline and 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia MLS | Change in Low Back Pain Visual Analog Scale (VAS) Score | -39.32 units on a scale | Standard Deviation 22.5 |
| Placebo Laser | Change in Low Back Pain Visual Analog Scale (VAS) Score | -5.52 units on a scale | Standard Deviation 20.17 |
p-value: <0.0001t-test, 2 sided
Secondary
Satisfaction With Study Outcome
At study endpoint, the subject was asked to rate how satisfied he or she was with any overall change in low back pain attained following the procedure administration phase with the Erchonia MLS Laser, using the following five-point scale: Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome.
Time frame: 4 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erchonia MLS | Satisfaction With Study Outcome | 26 participants |
| Placebo Laser | Satisfaction With Study Outcome | 7 participants |