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Influence of Patient-Informed Choice in a Novel Treatment Model for LBP

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. Identifier: NCT01744015
Recruitment Status : Withdrawn (We did not receive funding)
First Posted : December 6, 2012
Last Update Posted : July 10, 2013
Proaxis Therapy
Information provided by (Responsible Party):
Chad Cook, Walsh University

Brief Summary:
  1. (Primary) To compare the effectiveness of a patient guided choice of care using a patient decision support tool to clinical guided care within a novel care process for non-specific low back pain.

    (We hypothesize that the patient guided choice model will demonstrate significant improvements when compared to the clinician guided care approach)

  2. (Secondary) To qualitatively investigate which components of the patient choice educational methods were most effective for informed decision making among patients who participate in the patient guided choice of care approach (We hypothesize that dialogue method of patient guided choice will be identified as most useful)

Condition or disease Intervention/treatment Phase
Mechanical Low Back Pain Behavioral: Patient Decision Making tool Other: Standard of care Not Applicable

Detailed Description:
The purpose of this research study proposal is to evaluate patient choice within this physical therapist-led model for non-specific low back pain. Evidence exists that patients are eager to play an active role in decisions concerning their health. Recent evidence from research supports the benefit of decision aides for consumers, especially those that were accurate and refined to the specific problems of each patient. In our proposed randomized controlled trial (RCT), one group of patients in the study will have the opportunity to drive choices within their healthcare model; but only after receiving useful information on what the consequences of their selections will be. Patients will receive decision making information to assist in making an informed choice. The structured information will organize known results from the research literature to assist patients in understanding the likely outcome of their condition and what they need to adequately manage their own care. The control group of patients will receive the Physical therapist-directed care model that is presently used and has shown success. Patient outcomes will involve patient self report of improvement and whether or not the patient pursued care for the same condition over a 1 year period of time.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Influence of Patient-Informed Choice in a Novel Treatment Model for LBP: A Randomized Controlled Trial
Study Start Date : April 2013
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Patient Decision Making Tool
Patients will be given an opportunity to use a decision making tool to assist in decision making of their care
Behavioral: Patient Decision Making tool
The experimental group will consist of typical care from the physical therapist (as with the control group) with the addition of the patient decision support tool and information dissemination. The process of information dissemination for informed decision making. Based on the literature, we have deemed three points of informational contact as necessary to improve informed decision making. We plan to inform patients through the use of a) pre-material, b) dialogue, and c) reinforcement means.

Active Comparator: Standard of care
Control group consisting of normal care
Other: Standard of care
A control group will receive typical care from the physical therapist. Typical care includes physical therapist directed care of patients with low back pain, using standardized treatment algorithms (guideline oriented) for referral to physicians during cases of concern. In this model, a physician is consulted when the physical therapists feel it is necessary; or when directly requested by a patient. Physician consult is not normally provided as an option for the control group, unless evidence exists within the examination to suggest the need from a mutually agreed upon examination scheme including identification of red flags between the PT and physician. In the current model, because most of patients seen are diagnosed with non-specific LBP and do not require imaging or prescriptive medications, a majority are treated actively by the physical therapists-only during the initial visit.

Primary Outcome Measures :
  1. Care Seeking Behavior (recurrence of back pain) at 1 year [ Time Frame: 1 year status post discharge from formal physical therapy care ]
    Care seeking behavior is defined as a recurrence of symptoms, no resolution of symptoms at 1 year

Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: participants will be followed for the duration of the treatment which is on average 4 weeks ]
    At discharge (after care) the Oswestry will be measured and compared

Other Outcome Measures:
  1. Numeric Pain Rating Scale [ Time Frame: participants will be followed for the duration of the treatment which is on average 4 weeks ]
    At D/C, we will compare pain change scores

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older with mechanically producible LBP

Exclusion Criteria:

  • the presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy.

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 identifier (NCT number): NCT01744015

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United States, South Carolina
Proaxis Physical Therapy
Greenville, South Carolina, United States, 29602
Sponsors and Collaborators
Walsh University
Proaxis Therapy
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Principal Investigator: Chad E Cook, phd Walsh U
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Responsible Party: Chad Cook, Professor, Walsh University Identifier: NCT01744015    
Other Study ID Numbers: 6291965
WalshU1 ( Other Identifier: WalshU1 )
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: December 2012
Keywords provided by Chad Cook, Walsh University:
Low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations