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A Comparison of Two Different Methods of Physical Therapy to Treat Acute and Subacute Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02060617
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
David Candy, Hendricks Regional Health

Tracking Information
First Submitted Date  ICMJE December 1, 2013
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date September 29, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Change in Modified Oswestry Disability Questionnaire (ODQ) score [ Time Frame: Baseline, 4 weeks, 6 months ]
A measure of self-reported disability with scores ranging from 0% to 100% disability.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
  • Change in Numeric Pain Rating Scale (NPRS) score [ Time Frame: Baseline, 4 weeks, 6 months ]
    An 11 point scale in which patients rate their pain numerically with "0" representing no pain and "10" representing excruciating pain.
  • Global Rating of Change (GRC) [ Time Frame: 4 weeks, 6 months ]
    A self-report measure that asks subjects to rate the change in their symptoms from baseline. Scores range from +7 ("a very great deal better") to -7 ("a very great deal worse") with 0 representing no change.
  • Overall Treatment Success [ Time Frame: 4 weeks, 6 months ]
    Success will be defined as a 50% or greater improvement in modified Oswestry Disability Questionnaire score, a decrease in Numeric Pain Rating Scale score of 3.5 points or greater, and Global Rating of Change score of +5 ("quite a bit better") or greater. If all three of these criteria are met, the overall outcome will be considered "successful". If one or more of these criteria is not met, overall outcome will be considered "unsuccessful".
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 11, 2014)
  • Total Number of Visits [ Time Frame: At discharge, which will be approximately 4 weeks ]
    Total number of physical therapy visits completed.
  • Duration of Care [ Time Frame: At discharge, which will be approximately 4 weeks ]
    The number of days from the first physical therapy visit to the last physical therapy visit.
  • Number of adverse events from treatment [ Time Frame: up to 6 months ]
    Any adverse event reported as a result of treatment. Seriousness of adverse events will be graded on a 1 to 5 scale according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE) grading scale.
  • Number of patients seeking further treatment [ Time Frame: 6 months ]
    Number of patients seeking further treatment (i.e. continued physical therapy, acupuncture, chiropractic treatment, spinal injections, or surgery) for their low back pain at 6 month follow up.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Comparison of Two Different Methods of Physical Therapy to Treat Acute and Subacute Low Back Pain
Official Title  ICMJE Impairment-Based Versus Classification-Based Physical Therapy for Acute and Subacute Low Back Pain: a Randomized Controlled Trial
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Behavioral: Patient Education
    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.
  • Procedure: Manual therapy of the thoracolumbosacral spine and hips
    Thrust and/or non-thrust manipulation and soft tissue mobilization as determined by mobility impairments identified on clinical examination.
  • Procedure: Motor control exercises
    Motor control exercises as determined by motor control impairments identified on clinical examination.
  • Procedure: Treatment-Based Classification intervention
    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.
Study Arms  ICMJE
  • Experimental: Impairment-Based Group
    The impairment-based intervention will be a multi-modal treatment approach utilizing manual therapy of the thoracolumbosacral spine and hips as well as motor control exercises. Patient education will also be provided.
    Interventions:
    • Behavioral: Patient Education
    • Procedure: Manual therapy of the thoracolumbosacral spine and hips
    • Procedure: Motor control exercises
  • Active Comparator: Classification-Based Group
    Patients in this group will be categorized into subgroups according to the Treatment-Based Classification (TBC) Algorithm and treated accordingly. Patient education will also be provided.
    Interventions:
    • Behavioral: Patient Education
    • Procedure: Treatment-Based Classification intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2016)
23
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2014)
50
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • primary complaint of low back pain with or without leg symptoms
  • duration of symptoms 24 hours to 90 days
  • modified Oswestry score of 20 or greater
  • able to read and speak English.

Exclusion Criteria:

  • current pregnancy
  • spinal steroid injections within the past month
  • spinal surgery in the past 6 months
  • current worker's compensation or motor vehicle accident claim
  • presence of any red flag symptoms indicating possible serious pathology or non-musculoskeletal pain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02060617
Other Study ID Numbers  ICMJE 13-7
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Candy, Hendricks Regional Health
Study Sponsor  ICMJE Hendricks Regional Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David W Candy, DPT Hendricks Regional Health
PRS Account Hendricks Regional Health
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP