Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: Patient Education Procedure: Manual therapy of the thoracolumbosacral spine and hips Procedure: Motor control exercises Procedure: Treatment-Based Classification intervention Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Impairment-Based Versus Classification-Based Physical Therapy for Acute and Subacute Low Back Pain: a Randomized Controlled Trial
Study Start Date : April 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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".


Other Outcome Measures:
  1. Total Number of Visits [ Time Frame: At discharge, which will be approximately 4 weeks ]
    Total number of physical therapy visits completed.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060617


Locations
Layout table for location information
United States, Indiana
Hendricks Regional Health
Plainfield, Indiana, United States, 46168
Sponsors and Collaborators
Hendricks Regional Health
Investigators
Layout table for investigator information
Principal Investigator: David W Candy, DPT Hendricks Regional Health

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: David Candy, Physical Therapist, Hendricks Regional Health
ClinicalTrials.gov Identifier: NCT02060617     History of Changes
Other Study ID Numbers: 13-7
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016

Keywords provided by David Candy, Hendricks Regional Health:
low back pain
physical therapy
manual therapy
manipulation
exercise
motor control
regional interdependence

Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms