Study of Low Level Laser Therapy to Treat Low Back Pain

Completed · Not applicable · Has a placebo group

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT01835756

Run by

Erchonia Corporation

People needed

62

Starts

2012-09-01

Expected to finish

2014-09-01

Last updated by the study team

2016-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• South Mountain Chiropractic Center — Chandler, Arizona, United States
• Mark B. Burdorf DC — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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