Assessing the clinical prediction rule for spinal manipulation in a chronic lower back pain (LBP) populatio

Completed

• Conditions: Chronic Lower Back pain; Musculoskeletal Diseases; Low back pain

• Registration Number: ISRCTN30511490
• Lead Sponsor: .S. Department of Health and Human Services (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pain: Visual Analogue Scale<br>2. Disability: modified Oswestry Disability Index<br>Outcome measures were administered at: baseline, immediately post intervention (4 weeks post baseline), 12 weeks post baseline and 24 weeks post baseline.

Secondary Outcome Measures

Name	Time	Method
1. Bodily Pain and Physical Functional subscales of the SF-36<br>2. Patient Satisfaction<br>3. Patient Expectation<br>Outcome measures were administered at: baseline, immediately post intervention (4 weeks post baseline), 12 weeks post baseline and 24 weeks post baseline.