Clinical trial NCT01096628: Chiropractic and Exercise for Low Back Pain in Adolescents
Official title: Chiropractic and Exercise for Low Back Pain in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Low Back Pain
Keywords: adolescent
low back pain
chiropractic
exercise
Lead sponsor: Northwestern Health Sciences University
Sponsor class: OTHER
Collaborators: name: University of Western States
name: Health Resources and Services Administration (HRSA)
First posted: 2010-03-31
Enrollment: 185
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 the previous month
* 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

Primary outcomes:
measure: PATIENT-RATED LOW BACK PAIN
timeFrame: 3 and 12 months
Secondary outcomes:
measure: Disability
timeFrame: 3 and 12 months
measure: Quality of Life
timeFrame: 3 and 12 months
measure: Satisfaction with care
timeFrame: 3 and 12 months
measure: Patient-rated improvement
timeFrame: 3 and 12 months
measure: Guardian's satisfaction with care
timeFrame: 3 and 12 months
measure: Guardian's impression of Improvement
timeFrame: 3 and 12 months
measure: Lumbar Range of Motion
timeFrame: 3 and 6 months
measure: Lumbar muscle endurance
timeFrame: 3 and 6 months
measure: Physical activity Level
timeFrame: 3 and 6 months
measure: Expectations
timeFrame: Baseline
Other outcomes:
Locations:
city: Bloominton
country: United States
facility: Northwestern Health Sciences University
state: Minnesota
city: Portland
country: United States
facility: University of Western States
state: Oregon
Study officials:
affiliation: Northwestern Health Sciences University
name: Gert Bronfort, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leininger B, Schulz C, Gao Z, Bronfort G, Evans R, Pope Z, Zeng N, Haas M. Accelerometer-Determined Physical Activity and Clinical Low Back Pain Measures in Adolescents With Chronic or Subacute Recurrent Low Back Pain. J Orthop Sports Phys Ther. 2017 Oct;47(10):769-774. doi: 10.2519/jospt.2017.7345. Epub 2017 Sep 12.
citation: Schulz C, Leininger B, Evans R, Vavrek D, Peterson D, Haas M, Bronfort G. Spinal manipulation and exercise for low back pain in adolescents: study protocol for a randomized controlled trial. Chiropr Man Therap. 2014 May 23;22:21. doi: 10.1186/2045-709X-22-21. eCollection 2014.