Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135239
Status:
COMPLETED
Last Update Posted:
2008-06-17
First Post:
2005-08-23
Brief Title:
Study Care Versus Usual Care for Acute Mechanical Lower Back Pain
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Study Care Versus Usual Care for Acute Mechanical Lower Back Pain
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Objectives
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
Research Methodology
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
Recruitment
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
Randomisation
Patients will be randomized to receive treatment in either the CNOSP outpatient clinic EBC or from their family physicians UC
Intervention
All study patients will be assessed initially by a physician in the CNOSP outpatient clinic to confirm that they meet the inclusionexclusion 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 treatments 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
Statistical Analysis
The RDQ scores in the two groups will be compared using the Students 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 080 alpha 005 mean difference 3 points standard deviation 44 and allowing 25 for loss to follow-up
Non-Scientific Summary
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
Relevance
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 andor 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
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
Research Methodology
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
Recruitment
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
Randomisation
Patients will be randomized to receive treatment in either the CNOSP outpatient clinic EBC or from their family physicians UC
Intervention
All study patients will be assessed initially by a physician in the CNOSP outpatient clinic to confirm that they meet the inclusionexclusion 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 treatments 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
Statistical Analysis
The RDQ scores in the two groups will be compared using the Students 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 080 alpha 005 mean difference 3 points standard deviation 44 and allowing 25 for loss to follow-up
Non-Scientific Summary
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
Relevance
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None