Clinical trial: Lumbar Intervertebral Disc Herniation (NCT02110186)

Eligibility criteria:
Inclusion Criteria:

          -  Signed informed consent

          -  Age between 20 and 60 years inclusive

          -  Radiographic evidence of single level lumbar disc herniation

          -  Scheduled for single-level lumbar discectomy with or without fusion or dynamic
             stabilization

          -  Preoperative ODI ≥ 30

          -  Clinical symptoms consistent with lumbar disc herniation determined by history or
             physical exam:

               -  Radicular back or lower extremity pain and/or

               -  Decreased muscular strength and/or

               -  Abnormal sensation

          -  Involved disk at the spinal level between L2 and S1

          -  Failed to gain adequate symptom relief from at least one month of adequate
             non-operative treatment, except in patients with severe symptoms that require
             immediate surgery (at surgeon's discretion)

          -  Absence of significant symptomatic adjacent segment disk herniation

        Exclusion Criteria:

          -  Cauda equine syndrome

          -  Previous spinal surgery, except previous discectomy at the same segment

          -  Patients with other lumbar conditions that will, in the opinion of the investigator,
             interfere with clinical outcomes (e.g. spinal structural deformities, spinal
             fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal
             tumors, symptomatic cervical spinal disease)

          -  Osteoporosis defined as T-score ≤ -2.5. BMD will be measured by DEXA performed on
             lumbar spine

          -  Systemic infection such as AIDS, HIV, and active hepatitis

          -  Recent history (less than 3 years) of chemical substance dependency or significant
             psychosocial disturbance, which may impact the outcome or study participation

          -  Participation in a clinical trial of another investigational drug or device within the
             past 30 days
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 60 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? 0