Clinical trial: The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain (NCT02268305)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 57-year-old man comes to the emergency department due to constipation.  His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain.  There is no history of trauma. The pain is not relieved with over-the-counter pain medications.  His vital signs are within normal limits.  Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg.  Pinprick in the perianal area does not cause rapid contraction of the anal sphincter.  The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI.

Patient description (patient's own words): I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI.

Does the patient match the trial criteria? Contradiction