- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02538523
A Study to Evaluate the Effect of Low Level Laser Light on Low Back Pain
A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia FX-635 on Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
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, 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Chandler, Arizona, United States, 85226
- South Mountain Chiropractic Center
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California
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San Mateo, California, United States, 94402
- Quarneri Chiropractic Inc.
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Michigan
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Bloomfield, Michigan, United States, 48302
- Bloomfield Laser and Cosmetic Surgery Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Erchonia FX-635
The Erchonia FX-635 is made up of 3 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other.
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The Erchonia FX-635 is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.
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Placebo Comparator: Placebo Laser
The Placebo Laser has the same appearance as the Erchonia FX-635 but does not emit any therapeutic light.
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The Placebo Laser is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Whose Change in Pain Rating on the Visual Analog Scale (VAS) Met the Individual Subject Success Criteria
Time Frame: Baseline and Two Months Post-Procedure
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The Visual Analog Scale (VAS) assesses level or degree of pain.
It is a horizontal line anchored on the left by the label '0: no pain at all' and on the right by the label '100: worst pain imaginable'.
The subject marks a location on the 0-100 line that appears to represent any level of pain he or she is experiencing at that time.
This marking is measured with a 0 to 100 mm ruler and the number recorded.
For the primary study outcome, the percent change in the VAS pain score recorded at baseline and endpoint is calculated for each subject.
Individual subject success is a 30% or greater change in VAS pain scores.
A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success.
A positive (+) percent change indicates an increase in pain level and is negative for individual subject success.
Overall study success is defined as a 35% or greater difference between the proportion of individual successes in each treatment group.
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Baseline and Two Months Post-Procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Score on the Oswestry Disability Index (ODI)
Time Frame: Baseline and Two Months Post-Procedure
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The Oswestry Disability Index (ODI) is a 10-item questionnaire to quantify disability for acute or chronic low back pain.
Each question is scored on a scale of 0 (least amount of disability) to 5 (most severe disability).
The ODI is expressed as a percentage and calculated by dividing the summed score of all questions answered by the total possible score (that is dependent on how many questions are answered) and multiplying by 100.
A total score of '0%' means no disability and a total score of '100%' means the maximum disability possible.
Therefore, the higher the total score, the worse the disability, and the lesser the total score, the lesser the disability.
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Baseline and Two Months Post-Procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Trevor Berry, DC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC_LBP_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
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University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
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Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
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Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
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Universidade Federal do PiauíFoundation for Research Support of the State of PiauíCompletedLow Back Pain, Recurrent | Chronic Low Back PainBrazil
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Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedChronic Low Back Pain | Mechanical Low Back PainUnited States
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University of ExtremaduraCompletedChronic Low Back Pain | Postural Low Back PainSpain
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Université du Québec à Trois-RivièresCompletedChronic Low Back Pain | Mechanical Low Back PainCanada
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Erchonia CorporationCompletedOnychomycosisUnited States
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Erchonia CorporationCompleted
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Erchonia CorporationCompletedMusculoskeletal Pain | Neck Pain | Shoulder Pain | Musculoskeletal Strain | Musculoskeletal Sprain
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Scynexis, Inc.CompletedChronic Hepatitis CUnited States
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