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| Name | Class |
|---|---|
| Health Resources and Services Administration (HRSA) | FED |
| Berman Center for Outcomes and Clinical Research | OTHER |
The purpose of this randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.
Low back pain (LBP) is a significant health problem for both young and geriatric individuals. Of particular concern is that conditions associated with LBP, such as impaired strength and flexibility, can have very serious consequences for an older individual's independence and overall health.
The broad, long-term objective of this research is to identify effective therapies for low back pain (LBP) and to discover the best methods for enhancing health and functional capacity in the elderly population. This study is a multi-methods clinical trial consisting of a randomized clinical trial (RCT), a cost-effectiveness study alongside the RCT, and a qualitative study nested in the RCT.
This trial builds upon a previous study of chiropractic and exercise funded by HRSA, and focuses on elderly patients with sub-acute and chronic low back pain.
PRIMARY AIMS
To determine the relative clinical effectiveness the following treatments for LBP patients 65 years and older in both the short-term (after 12 weeks) and long-term (after 52 weeks), using low back pain as the main outcome measure
chiropractic manual treatment plus home exercise
supervised rehabilitative exercise plus home exercise
home exercise
SECONDARY AIMS
To estimate the short- and long-term relative effectiveness of the three interventions using:
Patient-rated outcomes: low back disability, general health status, patient satisfaction, improvement, and medication use measured by self-report questionnaires
Objective functional performance outcomes: spinal motion, trunk strength and endurance, and functional ability measured by examiners masked to treatment group assignment
Cost measures: direct and indirect costs of treatment measured by questionnaires, phone interviews, and medical records.
To describe elderly LBP patients' perceptions of treatment and the issues they consider when determining their satisfaction with care using qualitative methods nested within the RCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiropractic Manual treatment + home exercise (procedure+behavior) | Procedure | The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation, mobilization and flexion-distraction therapy with light soft tissue massage as indicated to facilitate the manual therapy. Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-rated pain (0-11 box scale) | short term = 12 weeks; long term = 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| General Health | short term = 12 weeks; long term = 52 weeks | |
| Disability | short term = 12 weeks; long term = 52 weeks | |
| Improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gert Bronfort, PhD | Northwestern Health Sciences University | Principal Investigator |
| Roni Evans, MS | Northwestern Health Sciences University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University | Bloomington | Minnesota | 55438 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31114673 | Derived | Schulz C, Evans R, Maiers M, Schulz K, Leininger B, Bronfort G. Spinal manipulative therapy and exercise for older adults with chronic low back pain: a randomized clinical trial. Chiropr Man Therap. 2019 May 15;27:21. doi: 10.1186/s12998-019-0243-1. eCollection 2019. | |
| 17877825 | Derived | Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007 Sep 18;8:94. doi: 10.1186/1471-2474-8-94. |
| Label | URL |
|---|---|
| Click here for a description of the Wolfe-Harris for Center for Clinical Studies | View source |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Supervised rehabilitative exercise+home exercise | Procedure | The rehabilitative exercise program will consist of 20, 1-hour sessions. It is a modification of exercise protocols used in previous studies by the investigators and incorporates recommendations of leading rehabilitative exercise specialists. Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active. |
|
| Home exercise | Behavioral | Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active. |
|
| short term = 12 weeks; long term = 52 weeks |
| Satisfaction | short term = 12 weeks; long term = 52 weeks |
| Medication use | short term = 12 weeks; long term = 52 weeks |
| Biomechanical test: Lumbar spinal motion Trunk strength & endurance Functional Ability Observed Pain Behavior | short term = 12 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |