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

Walsh University

Status: Withdrawn

Conditions: Mechanical Low Back Pain

Treatments: Other: Standard of care; Behavioral: Patient Decision Making tool

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01744015

6291965

WalshU1 (Other Identifier)

Details and patient eligibility

About

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)

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Patient Decision Making Tool

Experimental group

Description:

Patients will be given an opportunity to use a decision making tool to assist in decision making of their care

Treatment:

Behavioral: Patient Decision Making tool

Standard of care

Active Comparator group

Description:

Control group consisting of normal care

Treatment:

Other: Standard of care