ISRCTN30511490
Completed
Not Applicable
Evaluation of the clinical prediction rule for spinal manipulation in chronic lower back pain: a prospective randomized clinical trial
.S. Department of Health and Human Services (USA)0 sites192 target enrollmentStarted: September 6, 2013Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- .S. Department of Health and Human Services (USA)
- Enrollment
- 192
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\. LBP for 12 weeks prior to enrollment
- •2\. Pain upon deep palpation of the lumbar erector spinae
- •3\. LBP from L1 to sacroiliac joint inclusive
- •4\. Live within 50 miles of Rochester, NY
- •5\. Have a baseline \> 30mm on the Visual Analogue Scale (VAS) and \> 20% on the Oswestry Disability Index (ODI)
- •6\. Subjects had to be willing to undergo no new or different treatment during the study intervention and follow up period, although they were allowed to continue any medications.
Exclusion Criteria
- •1\. Radiographic or clinical evidence of cauda equina syndrome, spinal neoplasia or metastatic disease
- •2\. Destructive joint pathology such as rheumatoid arthritis
- •3\. Bowel/bladder dysfunction associated with the LBP
- •4\. Peripheral neuropathy or progressive lumbosacral radiculopathy
- •5\. Progressive myelopathy or neurogenic claudication
- •6\. Spinal surgery within the past six months.
- •7\. Subjects were excluded if they had undergone a course of SMT or supervised AET within the six months prior to enrollment into the study
- •8\. If they could not perform an exercise program based on a New York Heart Association Classification of grade III or IV
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