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| Name | Class |
|---|---|
| HRSA/Maternal and Child Health Bureau | FED |
| Berman Center for Outcomes and Clinical Research | OTHER |
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.
Low back pain remains an important public health problem with serious socioeconomic consequences. Despite the considerable amount of research that has been preformed, there is still a dire need for randomized clinical tiles of high methodological quality. The broad, long-term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and increased understanding of this important condition. Building upon the principal investigators' previous collaborative research, this randomized observer-blinded clinical trial will compare the following treatment for patients with nonacute low back pain:
Secondary aims include:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiropractic Spinal Manipulation | Procedure | |||
| Exercise | Procedure | |||
| Self-care | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria: patients are 18-65 years of age; Québec task force classification 1,2,3 and 4 (this includes patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs); primary complaint of back pain, with current episode greater than or equal to six weeks duration(this includes subacute and chronic patients for whom the study treatments are an option)
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gert Bronfort, DC, PhD | Northwestern Health Sciences University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Health Sciences University | Bloomington | Minnesota | 55431 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23661035 | Derived | 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. | |
| 21622028 | Derived | Bronfort 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009043 | Motor Activity |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026882 | Manipulation, Chiropractic |
| D015444 | Exercise |
| D012648 | Self Care |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D009043 | Motor Activity |
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| Disability (NHIS) at baseline, weeks 4,12,26,52 |
| Bothersomeness (7 point scale) at baseline, weeks 4,12,26,52 |
| Frequency (7 point scale) at baseline, weeks 4,12,26,52 |
| Satisfaction (5 point scale) at baseline, weeks 4,12,26,52 |
| Depression (CES-D) at baseline, weeks 4,12,26,52 |
| Medication use at baseline, weeks 4,12,26,52 |
| Fear-avoidance (FABQ) at baseline, weeks 4,12,26,52 |
| Lumbar range of motion at baseline, weeks 4,12,26,52 |
| Lumbar strength and endurance at baseline, weeks 4,12,26,52 |
| Health care costs and utilization at baseline, weeks 4,12,26,52 |
| D001519 | Behavior |
| D009068 |
| Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |