N/A
N=62
Study of Low Level Laser Therapy to Treat Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01835756 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Difference in the Proportion of Primary Outcome Successes Between Treatment Groups — 27; 9 participants — p=<0.00001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Erchonia MLS (Device); Placebo Laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Erchonia Corporation
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in the Proportion of Primary Outcome Successes Between Treatment Groups |
27; 9 | <0.00001 sig |
| SECONDARY Change in Low Back Pain Visual Analog Scale (VAS) Score |
-39.32; -5.52 | <0.0001 sig |
| SECONDARY Satisfaction With Study Outcome |
26; 7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01835756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.