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Chiropractic and Exercise for Low Back Pain in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01096628
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : January 31, 2014
Sponsor:
Collaborators:
University of Western States
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Northwestern Health Sciences University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Low Back Pain Other: Chiropractic + Exercise Other: Exercise Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chiropractic and Exercise for Low Back Pain in Adolescents
Study Start Date : March 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Chiropractic + Exercise 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.
Active Comparator: 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.


Outcome Measures
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Primary Outcome Measures :
  1. PATIENT-RATED LOW BACK PAIN [ Time Frame: 3 and 12 months ]
    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).


Secondary Outcome Measures :
  1. Disability [ Time Frame: 3 and 12 months ]
    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

  2. Quality of Life [ Time Frame: 3 and 12 months ]
    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.

  3. Satisfaction with care [ Time Frame: 3 and 12 months ]
    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).

  4. Patient-rated improvement [ Time Frame: 3 and 12 months ]
    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).

  5. Guardian's satisfaction with care [ Time Frame: 3 and 12 months ]
    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).

  6. Guardian's impression of Improvement [ Time Frame: 3 and 12 months ]
    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).

  7. Lumbar Range of Motion [ Time Frame: 3 and 6 months ]
    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.

  8. Lumbar muscle endurance [ Time Frame: 3 and 6 months ]
    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.

  9. Physical activity Level [ Time Frame: 3 and 6 months ]
    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.

  10. Expectations [ Time Frame: Baseline ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096628


Locations
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United States, Minnesota
Northwestern Health Sciences University
Bloominton, Minnesota, United States, 55431
United States, Oregon
University of Western States
Portland, Oregon, United States
Sponsors and Collaborators
Northwestern Health Sciences University
University of Western States
Health Resources and Services Administration (HRSA)
Investigators
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Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Northwestern Health Sciences University
ClinicalTrials.gov Identifier: NCT01096628    
Other Study ID Numbers: R18HP15124
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014
Keywords provided by Northwestern Health Sciences University:
adolescent
low back pain
chiropractic
exercise
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations