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| ID | Type | Description | Link |
|---|---|---|---|
| R18HP07638 |
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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192 patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome variable is leg pain and secondary outcome variables include low back pain, disability, bothersomeness and frequency of symptoms, general health status, and fear avoidance behavior.
Secondary aims are to describe and estimate between group differences in patient satisfaction, improvement, medication use, straight leg raise, torso endurance, and three biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response to sudden load. Patient perceptions of treatment will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Chiropractic Spinal Manipulative Therapy + Home exercise |
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| 2 | Active Comparator | Home exercise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home exercise | Other | Patient education will be provided by trained therapists under the supervision of licensed chiropractic clinicians. Patients will attend four, 1 hour, one-on-one sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-rated leg pain | short-term = 12 weeks; long-term = 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bothersomeness | short-term = 12 weeks; long-term = 52 weeks | |
| Frequency | short-term = 12 weeks; long-term = 52 weeks | |
| Disability |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Palmer Center for Chiropractic Research | Davenport | Iowa | 52803 | United States | ||
| Northwestern Health Sciences University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25222385 | Derived | Bronfort G, Hondras MA, Schulz CA, Evans RL, Long CR, Grimm R. Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain: a trial with adaptive allocation. Ann Intern Med. 2014 Sep 16;161(6):381-91. doi: 10.7326/M14-0006. | |
| 21426558 | Derived | Schulz CA, Hondras MA, Evans RL, Gudavalli MR, Long CR, Owens EF, Wilder DG, Bronfort G. Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial. Chiropr Man Therap. 2011 Mar 22;19:8. doi: 10.1186/2045-709X-19-8. |
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| Chiropractic Spinal Manipulative Therapy + Home exercise | Other | The number and frequency of treatments will be determined by the individual chiropractor, based on patient-rated symptoms, disability, palpation, and pain provocation tests. Up to 20 treatments will be provided over the 12 week treatment period, each treatment visit lasting from 10-20 minutes. Treatment will include manual spinal manipulation and mobilization. |
|
| short-term = 12 weeks; long-term = 52 weeks |
| General Health Status | short-term = 12 weeks; long-term = 52 weeks |
| Fear Avoidance | short-term = 12 weeks; long-term = 52 weeks |
| Patient Satisfaction | short-term = 12 weeks; long-term = 52 weeks |
| Improvement | short-term = 12 weeks; long-term = 52 weeks |
| Medication Use | short-term = 12 weeks; long-term = 52 weeks |
| Biomechanical test measures: Continuous lumbar motion, Standing postural sway, Neuromuscular response to a sudden load, Straight leg raise test, Torso muscle endurance | short-term = 12 weeks |
| Bloomington |
| Minnesota |
| 55337 |
| United States |