Manipulation, Exercise, and Self-Care for Low Back Pain
1 other identifier
interventional
300
1 country
1
Brief Summary
The broad, long term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and to increase our understanding of this important condition. The primary aim is to examine the relative efficacy of chiropractic spinal manipulation, rehabilitative exercise, and self-care education in terms of patient-rated outcomes in the short and long term for non-acute low back pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 low-back-pain
Started Jan 2001
Longer than P75 for phase_2 low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 21, 2005
CompletedFirst Posted
Study publicly available on registry
December 23, 2005
CompletedDecember 23, 2005
December 1, 2005
December 21, 2005
December 22, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
Secondary Outcomes (13)
Disability (Modified Roland Scale) at baseline, weeks 4,12,26,52
General Health (SF-36) at baseline, weeks 4,12,26,52
Improvement (7 point scale) at baseline, weeks 4,12,26,52
Disability (NHIS) at baseline, weeks 4,12,26,52
Bothersomeness (7 point scale) at baseline, weeks 4,12,26,52
- +8 more secondary outcomes
Interventions
Eligibility Criteria
You may not qualify if:
- previous lumbar spine surgery; back pain referred from local joint lesions of the lower extremities or from visceral diseases; progressive neurological deficits due to nerve root or spinal cord compression; aortic and peripheral vascular disease; existing cardiac disease requiring medical treatment; blood clotting disorders; diffuse idiopathic hyperostosis; infectious and noninfectious inflammatory or destructive tissue changes of the lumbar spine; presence of significant infectious disease, or other severe debilitating health problems; substance abuse; ongoing treatment for back pain by other health care providers; pregnant or nursing women; pain score of less than 30 percentage points; pending our current litigation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern Health Sciences University
Bloomington, Minnesota, 55431, United States
Related Publications (2)
Haanstra TM, Hanson L, Evans R, van Nes FA, De Vet HC, Cuijpers P, Ostelo RW. How do low back pain patients conceptualize their expectations regarding treatment? Content analysis of interviews. Eur Spine J. 2013 Sep;22(9):1986-95. doi: 10.1007/s00586-013-2803-8. Epub 2013 May 10.
PMID: 23661035DERIVEDBronfort G, Maiers MJ, Evans RL, Schulz CA, Bracha Y, Svendsen KH, Grimm RH Jr, Owens EF Jr, Garvey TA, Transfeldt EE. Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial. Spine J. 2011 Jul;11(7):585-98. doi: 10.1016/j.spinee.2011.01.036. Epub 2011 May 31.
PMID: 21622028DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gert Bronfort, DC, PhD
Northwestern Health Sciences University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 21, 2005
First Posted
December 23, 2005
Study Start
January 1, 2001
Study Completion
April 1, 2005
Last Updated
December 23, 2005
Record last verified: 2005-12