Study of Low Level Laser Therapy to Treat Low Back Pain

NCT01835756 | Completed Results

• 1 other identifier: EC_LBP_01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  4 Months

Secondary Outcomes (2)

• Change in Low Back Pain Visual Analog Scale (VAS) Score

  Baseline and 4 Months

• Satisfaction With Study Outcome

  4 Months

Study Arms (2)

Erchonia MLS

ACTIVE COMPARATOR

The Erchonia® MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light.

Device: Erchonia MLS

Placebo Laser

PLACEBO COMPARATOR

The Placebo Laser has the same appearance as the Erchonia MLS but does not emit any therapeutic light.

Device: Placebo Laser

Interventions

Erchonia MLS DEVICE

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.

Erchonia MLS

Placebo Laser DEVICE

The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.

Placebo Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (2)

South Mountain Chiropractic Center

Chandler, Arizona, 86226, United States

Location

Mark B. Burdorf DC

Scottsdale, Arizona, 85260, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Consultant
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

615-712-9743

Study Officials

• Trevor Berry, DC

  PRINCIPAL INVESTIGATOR

• Mark B Burdorf, DC, DACNB

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 19, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 2, 2016
• Results First Posted: February 2, 2016

Record last verified: 2015-11

Locations

US (2)