A Comparison of Two Different Methods of Physical Therapy to Treat Acute and Subacute Low Back Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Back Pain, Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| End Date: | June 2016 |
| Contact: | David W Candy, DPT |
| Email: | dwcandy@hendricks.org |
| Phone: | 317-838-3434 |
Impairment-Based Versus Classification-Based Physical Therapy for Acute and Subacute Low Back Pain: a Randomized Controlled Trial
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.
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.
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.
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.
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
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