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Portland |
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State:
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OR |
| Zip Code: |
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| Conditions: |
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Low Back Pain |
| Purpose: |
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Recent research has confirmed that low back pain (LBP) is a significant health problem not
only for adults, but also for children and adolescents. Given the enormous social and
economic costs associated with LBP, it is critical that attempts be made to decrease the
burden of LBP for patients and society.
The primary aim of this project is to determine the relative clinical effectiveness of 3
months of chiropractic care and supervised exercise versus supervised exercise in 184
adolescents with sub-acute recurrent, or chronic LBP. Relative effectiveness will be
evaluated in the short, intermediate and long term using pain as the primary outcome
measure. Secondary aims are to assess group differences in patient self-reported
disability, quality of life, perceived improvement, satisfaction, activity levels, lumbar
dynamic motion, and trunk muscle endurance. Patients' and caregivers' perceptions of
treatment using qualitative interviews will also be assessed.
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| Study summary: |
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This study is a two-site, prospective, parallel group, observer-blinded randomized
controlled trial (RCT). The objective of this study is to determine the relative clinical
effectiveness of 1) chiropractic care and supervised exercise; and 2) supervised exercise in
adolescents with sub-acute recurrent LBP (2-12 weeks duration) or chronic LBP (>12 weeks
duration ).
A total of 184 participants 12-18 years of age will be recruited from the Twin Cities of
Minneapolis/St.Paul and Portland metropolitan areas to the research clinics at Northwestern
Health Sciences University (NWHSU) and the University of Western States Portland(UWS). Data
collection measures and study protocols will be standardized across sites. The Office of
Data Management at NWHSU will serve as the central data coordinating center, with a
web-based interface for centralized data handling and treatment assignment.
Self-reported outcome measures assessing pain and disability, will be collected at baseline,
1, 2, 3, 4, 5, 6, and 12 months post-randomization. In addition, quality of life,
improvement, and satisfaction will be measured at months 3, 6 and 12. Objective outcome
measures including lumbar dynamic motion and trunk muscle endurance will be assessed by
blinded examiners at baseline and post-treatment phase (3 and 6 months). Patients will wear
accelerometers for the 7 days preceding follow up visits for months 3 and 6. Qualitative
patient interviews assessing patient and care-giver perceptions of care will be also be
conducted at 3 and 6 months. |
| Criteria: |
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Inclusion Criteria:
- 12-18 years of age
- Stable prescription medication plan (no changes in prescription medications that
affect musculoskeletal pain in the previous month)
- Primary complaint of low back pain > 3 on 0 to 10 scale
Either:
- Recurrent, sub-acute low back pain defined as current episode of 2-12 weeks duration
AND at least an additional 10 days of back pain in the past year OR
- Chronic low back pain defined as current episode >12 weeks duration
Exclusion Criteria:
- Chiropractic care or exercise therapy in prior 2 months
- Ongoing treatment for low back pain by other health care providers
- Other serious physical or mental health care conditions (for example diabetes,
cancer, etc.)
- Contraindications to study therapies including acute disc herniation, spondylolysis,
spondylolithesis, or inflammatory arthritides
- Benign joint hypermobility syndrome |
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| Study is available at: |
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Univeristy of Western States Portland
Portland, OR
United States
Primary Contact:
Mitchell Hass, MA, DC
Email: mhaas@wschiro.edu
Phone: 503-251-5728
Secondary Contact:
Gert Bronfort, DC, PhD
Email: gbronfort@nwhealth.edu
Phone: 952-885-5413 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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