A Phase 2/3 interventional study of Chiropractic + Exercise and Exercise in Low Back Pain, sponsored by Northwestern Health Sciences University. Completed at 2 sites in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2014-01-31.
Sponsored by Northwestern Health Sciences University · Phase 2/3, Interventional, and Treatment
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.
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.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's enrollment of 185 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Northwestern Health Sciences University is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Either:
Exclusion Criteria:
Other: Chiropractic + Exercise
Other: 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.
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.
PATIENT-RATED LOW BACK PAIN
Patients will be asked to rate their typical low back pain over the last week on an 11-box numerical rating scale (0=no pain, 10=the worst pain possible).
Time frame: 3 and 12 months
Disability
Disability will be measured with the Roland-Morris- 18 Scale, an 18-item questionnaire that measures the degree to which low back pain restricts patients' daily activities
Time frame: 3 and 12 months
Quality of Life
Measured using the 23-item PedsQL instrument which is a developmentally appropriate questionnaire for individuals 8-12 and 13-18 years of age and measures physical, emotional, social and school functioning domains.
Time frame: 3 and 12 months
Satisfaction with care
Satisfaction will be measured with a 7-item questionnaire addressing different aspects of patient care including information regarding cause, prognosis, activities, and prevention. Other aspects are concern shown by care provider, quality of recommendations and finally an overall rating of care. Each question will be evaluated on a 5-point Likert scale (1=poor, 5=excellent).
Time frame: 3 and 12 months
Patient-rated improvement
Patients will be asked to compare their low back pain condition to what it was before study treatment on a 9-point scale (100% worse to 100% better).
Time frame: 3 and 12 months
Guardian's satisfaction with care
Satisfaction will be measured with a 5-item questionnaire addressing concern shown by care provider, quality of recommendations and finally an overall rating of care. Each question will be evaluated on a 5-point Likert scale (1=poor, 5=excellent).
Time frame: 3 and 12 months
Guardian's impression of Improvement
Guardians will be asked to compare their child's low back pain condition to what it was before study treatment on a 9-point scale (100% worse to 100% better).
Time frame: 3 and 12 months
Lumbar Range of Motion
Lumbar spinal motion will be assessed using the Zebris CMS-HS Spine Motion Analyzer for (1)maximum ranges of motion in the sagittal, coronal, and axial planes and (2) maximum and average velocities and accelerations in the sagittal, coronal, and axial planes from neutral to end-ranges.
Time frame: 3 and 6 months
Lumbar muscle endurance
Blinded examiners will measure muscle endurance of the trunk flexors, lateral flexors, and extensors. Specifically, trunk extensors will be measured with the commonly used Biering-Sorensen Test and flexors will be assessed using protocols described by McGill.
Time frame: 3 and 6 months
Physical activity Level
Physical activity will be measured by having participants wear a GT1M accelerometer (Actigraph, Inc., Pensacola, FL) for 7 consecutive days. The GT1M is an electronic motion sensor accelerometer.
Time frame: 3 and 6 months
Expectations
Expectations will be evaluated pre-treatment based on questions that have been used in previous studies by the investigators. Prior to randomization, patients will be asked to rate how helpful they believe each treatment to be on an 11-box scale (0=not at all helpful, 10=extremely helpful). They will also be asked if they had a choice, which treatment would they choose.
Time frame: Baseline
The record gives a start of Mar 2010, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Northwestern Health Sciences University