Individualized Chiropractic and Integrative Care for Low Back Pain
|ClinicalTrials.gov Identifier: NCT00567333|
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : May 12, 2015
This study proposes to compare two innovative treatment approaches for LBP, both of which focus on delivering individualized care through evidence-based, clinical care pathways.
The primary aim of the project is to determine the relative clinical efficacy of 1) chiropractic care and 2) multidisciplinary, integrative care in 200 patients with sub-acute or chronic LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure in this study is patient-rated back pain.
Chiropractic care will include therapies within the professional scope of practice. Integrative, multidisciplinary care will include chiropractic, massage therapy, traditional Chinese medicine (including acupuncture), medication, cognitive behavioral therapy, exercise, and patient education.
Secondary aims are to assess between group differences in frequency of symptoms, disability, fear avoidance behavior, self efficacy, general health, improvement, patient satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods and cost-effectiveness and cost utility will be assessed in the short- and long-term.
This innovative study is an exciting collaboration between an experienced and established team of chiropractic, conventional, and CAM professionals dedicated to advancing the care of pervasive and costly LBP conditions. This trial will provide new and important information for all health care providers and LBP patients, informing decision making and improving care delivery systems.
|Condition or disease||Intervention/treatment||Phase|
|Sub-Acute and Chronic Low Back Pain||Other: Chiropractic care Other: Multidisciplinary, integrative care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Individualized Chiropractic and Integrative Care for Low Back Pain|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||December 2013|
Other: Chiropractic care
A combination of professional therapies with the scope of practice, including spinal manipulation therapy, spinal mobilization, stretching and strengthening exercises, and self-care education.
Other: Multidisciplinary, integrative care
A combination of therapies which may include acupuncture/Oriental medicine, chiropractic, cognitive behavioral therapy, exercise therapy, medicine, self-care information, and massage therapy.
- Patient-rated back pain. [ Time Frame: Short term: 12 weeks, Long term: 52 weeks ]
- Frequency of Symptoms [ Time Frame: 12 and 52 weeks ]
- Low Back Disability [ Time Frame: 12 and 52 weeks ]
- Fear Avoidance [ Time Frame: 12 and 52 weeks ]
- Self-Efficacy [ Time Frame: 12 and 52 weeks ]
- General Health Status [ Time Frame: 12 and 52 weeks ]
- Improvement [ Time Frame: 12 and 52 weeks ]
- Patient Satisfaction [ Time Frame: 12 and 52 weeks ]
- Work Loss [ Time Frame: 12 and 52 weeks ]
- Medication Use [ Time Frame: 12 and 52 weeks ]
- Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance. [ Time Frame: Short term: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567333
|United States, Minnesota|
|Northwestern Health Sciences University|
|Bloomington, Minnesota, United States, 55431|
|Principal Investigator:||Gert Bronfort, DC, PhD||Northwestern Health Sciences University|