Status:
COMPLETED
Study of Low Level Laser Therapy to Treat Low Back Pain
Lead Sponsor:
Erchonia Corporation
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01835756
Start Date
September 1 2012
End Date
September 1 2014
Last Update
February 2 2016
Active Locations (2)
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1
South Mountain Chiropractic Center
Chandler, Arizona, United States, 86226
2
Mark B. Burdorf DC
Scottsdale, Arizona, United States, 85260