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

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Active infection, wound or other external trauma to the treatment areas
• Prior surgery to the back or spine
• Medical, physical or other contraindications for, or sensitivity to, light therapy
• Pregnant, breast feeding, or planning pregnancy prior to study end
• Serious known mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years
• Mental illness/incompetence defined according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) definition and criteria
• Current and/or prior history of alcohol and/or other substance abuse, defined according to the DSM-V definition and criteria
• Developmental disability or cognitive impairment that may compromise study participation
• Involvement in litigation or receiving disability benefits related to the study parameters
• Participation in a clinical study or other type of research in the past 30 days