Chiropractic and Exercise for Low Back Pain in Adolescents
NCT01096628 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 185
Last updated 2014-01-31
Summary
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.
Conditions
- Low Back Pain
Interventions
- OTHER
-
Chiropractic + Exercise
Treatment will include eight to 16 treatments provided over the 12-week period. Each treatment visit will last from 10-20 minutes and consist of manual spinal manipulation and mobilization. Light soft tissue techniques (i.e., active and passive muscle stretching, hot and cold packs, and ischemic compression of tender points) will be used as indicated to facilitate the manual therapy. Patients will attend 8 to 16, one-on-one, 45-minute sessions over the course of 3 months. The sessions will follow a standardized approach but will be individualized to meet the patient's needs specific to their lifestyle, fitness level, and clinical characteristics. The exercise program will be comprised of three parts: 1) education, 2) supervised exercise, and 3) home exercise.
- OTHER
-
Exercise
Patients will attend 8 to 16, one-on-one, 45-minute sessions over the course of 3 months. The sessions will follow a standardized approach but will be individualized to meet the patient's needs specific to their lifestyle, fitness level, and clinical characteristics. The exercise program will be comprised of three parts: 1) education, 2) supervised exercise, and 3) home exercise.
Sponsors & Collaborators
-
University of Western States
collaborator OTHER -
Health Resources and Services Administration (HRSA)
collaborator FED -
Northwestern Health Sciences University
lead OTHER
Principal Investigators
-
Gert Bronfort, DC, PhD · Northwestern Health Sciences University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-03-31
- Primary Completion
- 2013-12-31
- Completion
- 2013-12-31
Countries
- United States
Study Locations
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