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Study of Low Level Laser Therapy to Treat Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erchonia MLS
Placebo Laser
Sponsored by
Erchonia Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Mountain Chiropractic Center
  • Mark B. Burdorf DC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Erchonia MLS

Placebo Laser

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 17, 2013
Last Updated
December 31, 2015
Sponsor
Erchonia Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01835756
Brief Title
Study of Low Level Laser Therapy to Treat Low Back Pain
Official Title
A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS) on Low Back Pain Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erchonia MLS
Arm Type
Active Comparator
Arm Description
The Erchonia® MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light.
Arm Title
Placebo Laser
Arm Type
Placebo Comparator
Arm Description
The Placebo Laser has the same appearance as the Erchonia MLS but does not emit any therapeutic light.
Intervention Type
Device
Intervention Name(s)
Erchonia MLS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo Laser
Intervention Description
The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
Primary Outcome Measure Information:
Title
Difference in the Proportion of Primary Outcome Successes Between Treatment Groups
Description
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
Secondary Outcome Measure Information:
Title
Change in Low Back Pain Visual Analog Scale (VAS) Score
Description
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
Title
Satisfaction With Study Outcome
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor Berry, DC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark B Burdorf, DC, DACNB
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Mountain Chiropractic Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
86226
Country
United States
Facility Name
Mark B. Burdorf DC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Low Level Laser Therapy to Treat Low Back Pain

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