Chiropractic and Exercise for Low Back Pain in Adolescents
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Chiropractic + Exercise; Exercise
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescent; low back pain; chiropractic; exercise