A Study to Evaluate the Effect of Low Level Laser Light on Low Back Pain

NCT02538523 | Completed Results FDA Device

• 1 other identifier: EC_LBP_002
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief Summary

This study evaluates the effect of low level laser light therapy on reducing low back pain. Half of the participants will receive the actual treatment with the active laser and the other half of the participants will receive a placebo treatment with an inactive laser.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Whose Change in Pain Rating on the Visual Analog Scale (VAS) Met the Individual Subject Success Criteria

  The Visual Analog Scale (VAS) assesses level or degree of pain. It is a horizontal line anchored on the left by the label '0: no pain at all' and on the right by the label '100: worst pain imaginable'. The subject marks a location on the 0-100 line that appears to represent any level of pain he or she is experiencing at that time. This marking is measured with a 0 to 100 mm ruler and the number recorded. For the primary study outcome, the percent change in the VAS pain score recorded at baseline and endpoint is calculated for each subject. Individual subject success is a 30% or greater change in VAS pain scores. A negative (-) percent change 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 is defined as a 35% or greater difference between the proportion of individual successes in each treatment group.

  Baseline and Two Months Post-Procedure

Secondary Outcomes (1)

• Change in Total Score on the Oswestry Disability Index (ODI)

  Baseline and Two Months Post-Procedure

Study Arms (2)

Erchonia FX-635

ACTIVE COMPARATOR

The Erchonia FX-635 is made up of 3 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other.

Device: Erchonia FX-635

Placebo Laser

PLACEBO COMPARATOR

The Placebo Laser has the same appearance as the Erchonia FX-635 but does not emit any therapeutic light.

Device: Placebo Laser

Interventions

Erchonia FX-635 DEVICE

The Erchonia FX-635 is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.

Erchonia FX-635

Placebo Laser DEVICE

The Placebo Laser is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.

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 region bound between the lowest rib and the crease of the buttocks
• Low back pain is of musculoskeletal origin wherein the etiology is lumbar sprain or strain
• Diagnosis is based on positive supportive patient history, physical examination, medication use history and review of relevant records and diagnostic tests
• Low back pain is episodic chronic, defined as pain having occurred on at least 15 days of each of the preceding 3 months, with each individual episode having lasted at least 24 hours followed by a subsequent period of at least 24 hours without pain
• Self-reported Degree of Pain rating on the 0-100 Visual Analog Scale (VAS) scale of 40 or greater
• Subject is willing and able to refrain from consuming any over-the-counter or prescription medications, including herbal supplements for the relief of pain or inflammation, including muscle relaxants throughout study participation, except for the study pain relief medication
• Subject is willing and able to refrain from non-study procedure therapies for 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 in whole or in part due to mechanical, inflammatory: neoplastic, metabolic or psychosomatic origins
• Non-organic pain, defined as positive findings for 3 or more of the 5 signs in the 'Waddell's Signs of Inorganic Behavior' list
• Known herniated disc injury
• Known osteoporosis with compression fractures
• Osteoporosis defined as a Total SCORE on the Simple Calculated Osteoporosis Risk Estimation (SCORE) screening questionnaire of \> 6, and a Dual-Energy X-ray Absorptiometry (DEXA) T-score ≤ -2.5
• Congenital deformity of the spine
• Current, active chronic pain disease
• Cancer or treatment for cancer in the past 6 months, including spinal cord tumors
• Use of the analgesics paracetamol, compound analgesics or topical analgesics within 7 days prior to treatment
• Use of the muscle relaxants cyclobenzaprine (Lexeril, Fexmid), diazepam (Valium) or meprobamate (Miltown®, Equinil®, Equagesic®, Meprospan®) within 30 days prior to treatment
• Use of the muscle relaxants Carisoprodol (Soma®, Sodol®, Soprodol®, Soridol®) or Metaxalone (Skelaxin, Robaxin) within 7 days prior to treatment
• Use of the antidepressants duloxetine (Cymbalta®, Effexor), amitriptyline, imipramine (Tofranil), clomipramine (Anafranil), nortriptyline (Pamelor), desipramine (Norpramin) or selective serotonin reuptake inhibitors (SSRIs) e.g. Paxil, paroxetine, fluoxetine (Prozac) initiated within 30 days prior to treatment
• Consumption of systemic corticosteroid therapy or narcotics within 30 days prior to treatment
• Local or epidural injection of corticosteroids in the back within 3 months prior to treatment
• Botulinum toxin (Botox®) injection for chronic low back pain within 4 months prior to treatment

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (3)

South Mountain Chiropractic Center

Chandler, Arizona, 85226, United States

Location

Quarneri Chiropractic Inc.

San Mateo, California, 94402, United States

Location

Bloomfield Laser and Cosmetic Surgery Center

Bloomfield, Michigan, 48302, 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: Elvira Cawthon
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

6154475150

Study Officials

• Trevor Berry, DC

  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: August 31, 2015
• First Posted: September 2, 2015
• Study Start: April 8, 2016
• Primary Completion: October 7, 2017
• Study Completion: December 10, 2017
• Last Updated: June 10, 2021
• Results First Posted: February 5, 2020

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)