Study Care Versus Usual Care for Acute Mechanical Lower Back Pain
|ClinicalTrials.gov Identifier: NCT00135239|
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : June 17, 2008
|Condition or disease||Intervention/treatment|
|Low Back Pain, Mechanical||Procedure: Study care Procedure: Usual care|
Hide Detailed Description
To determine if evidence-based care (EBC) is more effective than usual care (UC) in improving the functional status of patients with acute mechanical lower back pain. Our secondary objectives are to determine if EBC is effective in improving patient quality of life or time to return to work.
Design: This is a two arm, parallel design, randomized trial. Eligibility: Inclusion criteria are residents of British Columbia with mechanical lower back pain (Quebec Task Force on Spinal Disorders Classification categories 1 or 2) of up to four weeks duration.
All study patients will be recruited from the patient population currently referred for assessment at the Combined Neurosurgical and Orthopaedic Spine Program (CNOSP) outpatient clinic (OPC).
Patients will be randomized to receive treatment in either the CNOSP outpatient clinic (EBC) or from their family physicians (UC).
All study patients will be assessed initially by a physician in the CNOSP outpatient clinic to confirm that they meet the inclusion/exclusion criteria of the study. Patients receiving the EBC intervention will then receive re-assurance, advice to avoid passive treatments, acetominophen (except where contraindicated) for a period of 2-4 weeks, a four week course of lumbar spine spinal manipulative therapy administered by a CNOSP Chiropractor and advice to return to work in some capacity within eight weeks following the start of treatment. Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.
Outcomes of Interest:
Primary Outcome: Our primary outcome of interest is the difference in the mean changes in functional improvement at sixteen weeks after the start of treatment, defined as the change in modified Roland Disability (RDQ) scores, between the EBC and the UC patient groups.
Secondary Outcomes: Secondary outcomes of interest are the difference in the mean changes in functional improvement at eight weeks and twenty-four weeks after the start of treatment defined as change in modified Roland Disability (RDQ) scores, differences in time to return to work and differences in the 'Bodily Pain and 'Physical Functioning' domains of the SF-36 questionnaire, between the EBC and the UC patient groups.
The RDQ scores in the two groups will be compared using the Student's T Test. Analysis of co-variance will be used if necessary to adjust for a difference in baseline functional status using baseline RDQ scores as a co-variate. Time to return to work will be compared using Kaplan Meier survival analysis. A between group comparison of survival will be performed using the log-rank test. SF 36 scores will be normalized and the Bodily Pain" and Physical Functioning scales will be compared between the EBC and UC groups, again using an unpaired t-test and if necessary, analysis of covariance. Estimated sample size: 88 subjects are required based on a two-sided independent T Test. Power + 0.80, alpha + 0.05, mean difference + 3 points, standard deviation + 4.4 and allowing 25% for loss to follow-up.
The most common work-related injury in British Columbia every year is a lower back injury. The many different treatment options that are available to workers with a back injury have often led to confusion and frustration. New back pain research has shown which combinations of treatments are most helpful, but has also shown that many injured workers in British Columbia do not have these treatments made readily available to them. This research study is designed to accurately determine whether or not providing patients suffering from acute back injuries with a combination of all of these recommended treatments, will improve their function, quality of life and return to work.
- Why is this study a high priority for WCB funding?
Lower back injuries remain the single most common category of claim for loss made by injured workers. A recent study has shown that the majority of workers in British Columbia with lower back injuries are now receiving treatments that are inconsistent with internationally developed, evidence-based clinical practice guidelines. In addition, a preliminary research study has shown that many aspects of patient recovery from a lower back injury are enhanced by the use of guideline-recommended treatments when compared with guideline discordant treatments.
The proposed study will accurately determine the value of treating lower back-injured patients with a combination of evidence-based treatments. In addition, the results of this study have the potential to significantly impact many issues that are of key importance to the WCB including improving the quality of life of patients with acute lower back injuries, reducing the use of inappropriate treatments that may promote disability and reducing the costs associated with the treatment of these patients.
- What impact will research outcomes have on BC workplaces?
The outcomes of this research study will help clarify the uncertainty that currently exists with respect to which treatments or combination of treatments, are most helpful for lower back-injured workers. The results of this study have the potential to greatly improve the treatment and/or rehabilitation that these patients are currently receiving in British Columbia, and therefore reduce the disability that is associated with a work-related lower back injury.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study Care Versus Usual Care for Acute Mechanical Lower Back Pain|
|Study Start Date :||January 2006|
|Primary Completion Date :||June 2008|
|Study Completion Date :||June 2008|
Procedure: Study care
- To determine if study-based care (SC) is more effective than usual care (UC) in the treatment of patients with acute mechanical lower back pain after 16 weeks [ Time Frame: 16 weeks ]
- To determine if SC is more effective than UC in improving the functional status of patients with acute mechanical lower back pain at 8 weeks and 24 weeks. [ Time Frame: 24 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135239
|Canada, British Columbia|
|Medical Rapid Access Spine Clinic|
|Vancouver, British Columbia, Canada, V5Z 3J5|
|Principal Investigator:||Dr. Paul Bishop, MD||University of British Columbia|