A Comparison of Two Different Methods of Physical Therapy to Treat Acute and Subacute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Recent research has shown that classifying patients with low back pain into treatment
      subgroups results in better improvements than treating all patients with low back pain the
      same. However, physical therapists may use different types of information to determine how to
      classify their patients. One method uses patient characteristics that have been shown by
      research to predict good results from a certain type of treatment. Another method uses
      specific impairments that the physical therapist identifies in a clinical exam to determine
      which treatment to provide. It is not currently known if one of these methods is better than
      the other. The purpose of this study is to determine if research-based classification or
      impairment-based treatment is more effective for treating patients with low back pain that
      has lasted less than 90 days in terms of improvements in pain and disability. The results of
      this study may help reduce the high financial cost associated with low back pain.
    

Detailed description: 
      PURPOSE: The purpose of this study is to describe a multimodal impairment-based clinical
      model for the treatment of low back pain utilizing the concept of Regional Interdependence
      (Wainner et al 2007) and to determine the relative effectiveness of this model versus
      classification-based therapy using the Treatment-Based Classification System for acute and
      subacute low back pain (Delitto et al 1995, Fritz et al 2006, Fritz et al 2007) in terms of
      improvements in pain and disability at 4 weeks and 6 months.

      BACKGROUND: Recent studies have shown that subclassifying patients with low back pain into
      treatment groups results in better outcomes than treating all patients with low back pain as
      homogenous groups. (Fritz et al 2003) However, no studies have directly compared the efficacy
      of impairment-based versus classification-based physical therapy for patients with acute and
      subacute low back pain.

      HYPOTHESIS: We suspect that both methods of treatment will be effective, but we are uncertain
      if one will be more effective than the other. Therefore, our null hypothesis will be that
      both methods will be equally effective.

      METHODS:

        1. Patients referred to physical therapy at Hendricks Regional Health in Plainfield, IN
           will be screened for eligibility. Eligible participants will be offered the opportunity
           to voluntarily participate in the research study. Those patients who are both eligible
           and interested will receive an informed consent form approved by the Hendricks Regional
           Health Institutional Review Board.

        2. All subjects will complete a standard intake form and self-report measures. The
           principal investigator will obtain a subjective history from the patient and perform a
           standardized baseline physical examination.

        3. After the baseline examination, subjects will be randomized in blocks of 4, 6, or 8
           using a concealed, computer-generated randomization sequence accessed electronically
           through a Microsoft Excel spreadsheet using the VLOOKUP function to return the group
           assignment when the subject number is entered.

        4. All subjects in both groups will be treated by the principal investigator two times per
           week for two weeks followed by once per week for two weeks (total of 6 visits)
           regardless of treatment group assignment. All subjects will receive standardized
           education as well as additional individualized education as deemed appropriate by the
           treating clinician. Subjects will be given a home exercise program consisting of the
           same exercises they performed in physical therapy and asked to perform their exercises
           twice per day.

        5. Patients in the impairment-based group will be treated using a multi-modal treatment
           approach utilizing manual therapy of the thoracolumbosacral spine and hip as well as
           motor control exercises. Patients in the classification-based group will be categorized
           into subgroups according to the previously described Treatment-Based Classification
           (TBC) Algorithm and treated accordingly.

        6. After completion of the 6 visits, we intend to discharge most patients to a home
           exercise program. However, patients who require more or fewer visits than this will
           still be included in the intention-to-treat analysis. Patients will be encouraged to
           perform their home exercises at least 3 times per week until the 6 month follow up.

        7. Primary and secondary outcome measures will be collected at 4 weeks and 6 months from
           baseline.

      DATA ANALYSIS:

      Study data will be analyzed using SPSS Statistical Software (IBM, Armonk, NY).

        1. Baseline characteristics will be examined for between group differences.

        2. Primary outcomes will be analyzed using a repeated measures analysis of co-variance
           (ANCOVA) to examine a group x time interaction for pain and disability at baseline, 4
           weeks, and 6 months controlling for baseline covariates of Fear Avoidance Behavior
           Questionnaire physical activity subscale score (FABQpa), duration of symptoms, and prior
           history of low back pain. Median and range values will be calculated for Global Rating
           of Change at 4 weeks and 6 month. Primary outcome measures will also be dichotomized and
           combined in order to determine overall treatment success for the 4 week and 6 month
           follow ups.

        3. Intention-to-treat analysis using multiple imputation to account for missing values will
           be used in all analyses. A secondary per-protocol analysis will be performed for
           patients who completed exactly 6 visits, performed their home exercise program at least
           6 times per week, and completed all outcomes at all time points.
    

Intervention name(s): Patient Education; Manual therapy of the thoracolumbosacral spine and hips; Motor control exercises; Treatment-Based Classification intervention
Intervention type(s): Behavioral; Procedure; Procedure; Procedure
Intervention description(s): All subjects will receive education that back pain is common but rarely harmful in nature, that pain does not necessarily mean that there is structural damage to their back, and that they should try to remain as active as they are able within the limits of their pain. In addition, individualized education regarding posture, body mechanics, sleeping positions, or other concerns of the patient will be provided on a pragmatic basis as deemed appropriate by the treating clinician.; Thrust and/or non-thrust manipulation and soft tissue mobilization as determined by mobility impairments identified on clinical examination.; Motor control exercises as determined by motor control impairments identified on clinical examination.; Lumbopelvic manipulation and range of motion exercise, spinal stabilization exercises, direction specific exercises, and/or traction will be applied as determined by the Treatment-Based Classification (TBC) Algorithm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: low back pain; physical therapy; manual therapy; manipulation; exercise; motor control; regional interdependence