Study Care Versus Usual Care for Acute Mechanical Lower Back Pain
Condition: Low Back Pain, Mechanical
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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 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.

      Statistical Analysis:

      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.

      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 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.
    

Intervention name(s): Study care; Usual care
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: back; Lower Mechanical Back Pain; Rehabilitation