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N/A N=62 Randomized Triple-blind Treatment

Study of Low Level Laser Therapy to Treat Low Back Pain

Low Back Pain

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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