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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 clinical trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.
Neck pain (NP) is a considerable health problem, affecting both young and elderly individuals. Of particular concern is the negative impact NP may have on the functional ability of the geriatric population, already challenged by decreased mobility and balance associated with ageing. Chiropractic manual treatment and rehabilitative exercise have demonstrated potential for the treatment of NP in younger individuals, but have yet to be rigorously tested in the elderly.
The broad, long-term objective of this research is to identify effective therapies for patients, 65 years and older, who suffer with chronic neck pain and to enhance their functional capacity.
Primary Aims
• To determine the relative clinical effectiveness of 1) chiropractic manual treatment and home exercise, 2) supervised rehabilitative exercise and home exercise, and 3) home exercise alone in both the short-term (after 12 weeks) and long-term (after 52 weeks), using patient-rated neck pain as the main outcome measure.
Secondary Aims
To estimate the short- and long-term relative effectiveness of the three interventions using:
To describe patients' perceptions of treatment and the issues they consider when determining their satisfaction with care.
This project is a collective effort by a multidisciplinary team, with an established record of collaborative research in the area of neck and back pain. The results of this study will provide valuable information for elderly neck pain sufferers and the clinicians who treat them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Chiropractic Manual Treatment + Home Exercise |
|
| 2 | Experimental | Supervised Rehabilitative Exercise + Home Exercise |
|
| 3 | Active Comparator | Home Exercise |
|
| 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 and mobilization with light soft tissue massage as indicated to facilitate the manual therapy. Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck 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 (0-10 scale, 11 box) | 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, DC, PhD | Northwestern Health Sciences University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University | Bloomington | Minnesota | 55431 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27345747 | Derived | Leininger B, McDonough C, Evans R, Tosteson T, Tosteson AN, Bronfort G. Cost-effectiveness of spinal manipulative therapy, supervised exercise, and home exercise for older adults with chronic neck pain. Spine J. 2016 Nov;16(11):1292-1304. doi: 10.1016/j.spinee.2016.06.014. Epub 2016 Jun 23. | |
| 24225010 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Supervised rehabilitative exercise + home exercise | Procedure | The rehabilitative exercise program will consist of 20, 1 hour small-group sessions. It is a modification of exercise protocols used in previous studies by the investigators and others and incorporates recommendations of leading rehabilitative exercise specialists. The program will include exercises that reduce joint stiffness and relax elastic structures resulting in lower joint loads during movements. Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck 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, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck 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 tests: Cervical spine motion, Strength and Endurance, Functional Ability, Observed Pain Behavior | short term = 12 weeks |
| Maiers M, Bronfort G, Evans R, Hartvigsen J, Svendsen K, Bracha Y, Schulz C, Schulz K, Grimm R. Spinal manipulative therapy and exercise for seniors with chronic neck pain. Spine J. 2014 Sep 1;14(9):1879-89. doi: 10.1016/j.spinee.2013.10.035. Epub 2013 Nov 10. |
| 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. |
| D001519 | Behavior |