Clinical trial: Immediate Pain Relieving Effects of Sinbaro-3 for Low Back Pain (NCT02196129)

Eligibility criteria:
Inclusion Criteria:

          -  Patients admitted to a Korean Medicine hospital for low back pain with or without
             radiculopathy

          -  Age between 18 and 69

          -  NRS score of >6 on the day of the intervention

          -  Voluntary participation with written consent given to study consent form

        Exclusion Criteria:

          -  Diagnosis of serious disease(s) which are possible causes of back pain such as
             malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda
             equina compression, etc.

          -  Prior diagnosis of other chronic disease(s) which could affect effectiveness or
             interpretation of treatment results such as cardiovascular disease, diabetic
             neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.

          -  Progressive neurologic deficit(s) or concurrent severe neurological symptoms

          -  Unsuitable for or at risk of complications from acupuncture treatment such as patients
             with clotting disorders, severe diabetes with risk of infection, serious
             cardiovascular disease, or undergoing anticoagulant treatment, etc.

          -  Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine,
             or other medication considered unsuitable for subjects by the researcher

          -  Experience of gastroenteric complications after taking NSAIDs or currently undergoing
             treatment for digestive disorders

          -  During pregnancy or suspected pregnancy

          -  Subjects considered unsuitable for clinical trial by the researcher
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 69 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