Status:
COMPLETED
The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain
Lead Sponsor:
Mike O'Callaghan Military Hospital
Conditions:
Low Back Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The investigators are studying whether MSM plus standard of care naproxen improves symptoms of lower back pain compared to standard of care naproxen plus placebo. Subjects will be randomized into 1 of...
Detailed Description
We will recruit male and female MOFMC DoD beneficiaries between the ages of 18-65 years old with symptoms of lower back pain from any of the clinics at the MOFMC at Nellis Air Force Base. Patients tak...
Eligibility Criteria
Inclusion
- THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.
- Inclusion:
- DoD beneficiaries between the ages of 18-65 years old Symptoms of Low Back Pain greater than 12 weeks duration Patients with a history of lower back surgery may be included
- Exclusion:
- DoD beneficiaries less than 18 years old or greater than 65 years old
- Lower back pain caused by any of the following:
- Infection Tumor Osteoporosis Ankylosing spondylitis Fracture Deformity Inflammatory process Cauda equina syndrome Treated or untreated central nervous system impairment
- Meeting the criteria for surgery, including:
- progressive motor deficit sphincter impairment from neurological cause disabling sciatic pain (in the absence of backache) lasting 6 weeks or more that is attributed to a compromised nerve root and demonstrated by magnetic resonance imaging or computed tomography Oncologic disease during the previous 5 years Unexplained weight loss, fever, or chills Diagnosed upper urinary tract infection within last 28 days Patients identified during standard of care interview to have a history of intravenous drug use.
- Immunocompromised host
- A severe comorbidity to include:
- determining overall well-being (e.g. painful disabling arthritic hip joints) Cirrhosis Ongoing dialysis Radiating symptoms to lower extremities (sciatica) History of bleeding disorders History of high blood pressure History of heart, kidney, liver or ulcer disease Allergic to analgesics or Non-steroidal anti inflammatory agents (NSAIDs) Pregnant or breastfeeding Initial pain rating of greater than 8/10 on initial intake evaluation If any of the components of the comprehensive metabolic panel are outside the Nellis clinical laboratory reference ranges, the subject will be excluded from the study
- If any of these four components of the complete blood count are outside of the Nellis clinical laboratory reference ranges, the subject will be excluded from the study:
- White blood cell count Hemoglobin Hematocrit Platelets
- Patients taking any of the following medications are excluded from participating, unless they agree to wash out for two weeks prior to entering the study:
- Muscle relaxers of any type Non-steroidal anti-inflammatory agents (NSAIDs) \* Patients taking naproxen must agree to wash out for two weeks prior to entering the study, but can begin taking it again, as prescribed, after Visit 1 where a baseline pain assessment is performed.
- Tramadol Gabapentin Pregabalin Glucosamine Narcotic pain medications
Exclusion
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02268305
Start Date
February 1 2015
End Date
June 5 2018
Last Update
April 5 2024
Active Locations (1)
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1
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, United States, 89191