Clinical trial: Comparison of Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain (NCT00497861)

Eligibility criteria:
Inclusion Criteria:

          1. Being 18 years or older;

          2. Having current acute or sub-acute low back pain defined as pain that has not lasted
             more than 16 weeks;

          3. Minimum score of 30mm on a 100mm visual analog pain scale.

        Exclusion Criteria:

        Exclusion criteria consisted of the following:

          1. Have any of six possible un underlying causes of low back symptoms in their history
             (spinal osteomyletisosteomyelitis, spinal fracture, herniated disc, ankylosing
             spondylitis, cauda equina syndrome, or cancer, excluding nonmalignant skin cancer);

          2. Have undergone surgery involving the low back; (

          3. Have received workers'compensation benefits within the preceding year or were
             potentially involved in litigation relating to back problems;

          4. Pregnancy, because of possible need for exposure to diagnostic x-rays;

          5. Have participated as a subject in research previously at the trial clinic site;

          6. Have received spinal manipulation within the preceding 3 months or on more than three
             occasions during the preceding year.

          7. Subjects with sciatica were excluded if they had any one of the following:

               -  Ankle dorsiflexion / plantar flexion weakness;

               -  Great toe extensor weakness;

               -  Absence of knee or ankle reflexes;

               -  Loss of light touch sensation in the medial, dorsal, and lateral aspects of the
                  foot;

               -  Ipsilateral straight-leg-raising test (positive result: leg pain at <60°);

               -  Crossed straight-leg-raising test (positive result: reproduction of contralateral
                  pain).

             These six neurologic tests allow detection of most clinically significant nerve root
             compromises resulting from L4-L5 or L5-S1 disc herniations, which together make up
             more than 90% of all clinically significant radiculopathies attributable to lumbar
             disc herniations (21-25). Because approximately 12% of ambulatory patients with back
             pain h

          8. Have symptoms of sciatica or leg pain without neurologic compromise related to lumbar
             disc herniation,[5] investigators attempted to include such subjects in the trial.

        The criteria described above were intended to minimize the likelihood of including subjects
        with a lumbar disc herniation.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.


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