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

Evaluation of the clinical prediction rule for spinal manipulation in chronic lower back pain: a prospective randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30511490
Enrollment
192
Registered
2013-09-06
Start date
2006-06-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lower Back pain Musculoskeletal Diseases Low back pain

Interventions

Interventions were performed two times per week for four weeks (total of eight treatments). Spinal Manipulative Therapy: SMT included high velocity low amplitude spinal manipulation, flexion distract

Sponsors

U.S. Department of Health and Human Services (USA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Pain: Visual Analogue Scale 2. Disability: modified Oswestry Disability Index Outcome measures were administered at: baseline, immediately post intervention (4 weeks post baseline), 12 weeks post baseline and 24 weeks post baseline.

Secondary

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

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026