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

This study has been withdrawn prior to enrollment.
(We did not receive funding)
Sponsor:
Collaborator:
Proaxis Therapy
Information provided by (Responsible Party):
Chad Cook, Walsh University
ClinicalTrials.gov Identifier:
NCT01744015
First received: December 2, 2012
Last updated: July 9, 2013
Last verified: December 2012
  Purpose
  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 Intervention
Mechanical Low Back Pain
Behavioral: Patient Decision Making tool
Other: Standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Influence of Patient-Informed Choice in a Novel Treatment Model for LBP: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Walsh University:

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


Secondary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: participants will be followed for the duration of the treatment which is on average 4 weeks ] [ Designated as safety issue: No ]
    At discharge (after care) the Oswestry will be measured and compared


Other Outcome Measures:
  • Numeric Pain Rating Scale [ Time Frame: participants will be followed for the duration of the treatment which is on average 4 weeks ] [ Designated as safety issue: No ]
    At D/C, we will compare pain change scores


Enrollment: 0
Study Start Date: April 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Patient Decision Making tool
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.
Other Name: Standard of care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744015

Locations
United States, South Carolina
Proaxis Physical Therapy
Greenville, South Carolina, United States, 29602
Sponsors and Collaborators
Walsh University
Proaxis Therapy
Investigators
Principal Investigator: Chad E Cook, phd Walsh U
  More Information

No publications provided

Responsible Party: Chad Cook, Professor, Walsh University
ClinicalTrials.gov Identifier: NCT01744015     History of Changes
Other Study ID Numbers: 6291965, WalshU1
Study First Received: December 2, 2012
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Walsh University:
Low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014