Clinical trial NCT01744015: Influence of Patient-Informed Choice in a Novel Treatment Model for LBP
Official title: Influence of Patient-Informed Choice in a Novel Treatment Model for LBP: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mechanical Low Back Pain
Keywords: Low back pain
Lead sponsor: Walsh University
Sponsor class: OTHER
Collaborators: name: Proaxis Therapy
First posted: 2012-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)

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 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.

Primary outcomes:
measure: Care Seeking Behavior (recurrence of back pain) at 1 year
timeFrame: 1 year status post discharge from formal physical therapy care
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: participants will be followed for the duration of the treatment which is on average 4 weeks
Other outcomes:
measure: Numeric Pain Rating Scale
timeFrame: participants will be followed for the duration of the treatment which is on average 4 weeks
Locations:
city: Greenville
country: United States
facility: Proaxis Physical Therapy
state: South Carolina
Study officials:
affiliation: Walsh U
name: Chad E Cook, phd
role: PRINCIPAL_INVESTIGATOR
References: