Chiropractic and Exercise for Low Back Pain in Adolescents

Low Back Pain Clinical Trial

Official title: Chiropractic and Exercise for Low Back Pain in Adolescents

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

• NCT number: NCT01096628
• Study type: Interventional
• Source: Northwestern Health Sciences University
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2010
• Completion date: December 2013