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

Completed · Not applicable · Has a placebo group

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT02538523

Run by

Erchonia Corporation

People needed

58

Starts

2016-04-08

Expected to finish

2017-12-10

Last updated by the study team

2021-06-10

Who can join

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

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
• 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

Where it is running

• South Mountain Chiropractic Center — Chandler, Arizona, United States
• Quarneri Chiropractic Inc. — San Mateo, California, United States
• Bloomfield Laser and Cosmetic Surgery Center — Bloomfield, Michigan, United States

Full record on ClinicalTrials.gov

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