Study of Low Level Laser Therapy to Treat Low Back Pain

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, and it is the most common cause of job-related disability and a leading
contributor to missed work. Around $50 billion is spent in the U.S. each year to treat low
back pain. Men and women are equally affected, with the most common age affected being
between 30 and 50 years.

Most low back pain stems from benign musculoskeletal problems, referred to as non-specific
low back pain, which is the etiology being evaluated in this study. It is caused by lumbar
sprain or strain a stretch injury to the ligaments, tendons, and/or muscles of the low back.

Current mainstream treatment approaches for low back pain due to lumbar sprain strain focus
on reducing pain and inflammation, including rest; oral and topical over-the-counter and
prescription medications; local heat applications; massage and exercise. Alternative
treatment options include acupuncture; chiropractic manipulation; biofeedback; traction;
transcutaneous electrical nerve stimulation (TENS); and ultrasound. Surgical procedures are
also a treatment option for low back pain, and although the outcomes are often poor and do
not last, back surgery remains the 3rd most common form of surgery in the United States,
with about 300,000 back surgeries performed annually.

Low Level Laser Therapy (LLLT) communicates information to the receptors on the membrane of
the cell and mitochondrion (the enzymatic engine of the cell). This energetic information
reaches the cell's DNA, which directly controls cell function. When the cells receive better
information, they work better, as do the tissues they comprise, like bones, cartilage,
tendons, ligaments, etc. In this way, LLLT promotes the healing and regeneration of damaged
tissues, having both local effects on tissue function and also systemic effects carried
throughout the body by the blood and acupuncture meridians. The key basic physiological
effects of low level laser light include increased cell membrane polarization and
permeability; Adenosine-5-triphosphate (ATP) production and respiratory chain activity;
enzyme activity; collagen and epithelial production; capillary formation; macrophage
(immune) activity; analgesic effects due to elevated endorphin production, electrolytic
nerve blockage, and improved blood and lymph flow; anti-inflammatory effect due to improved
circulation and accelerated tissue regeneration; and increased production of antioxidants.
Of additional benefit is that light energy from low level lasers will only be absorbed by
cells and tissues that are not functioning normally and has no effect on healthy cells.

Therefore, low level laser therapy has the potential benefit of providing an effective means
of reducing low back pain that is simple, quick, non-invasive and side-effect free.

Inclusion Criteria:

- 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 Criteria:

- 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