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

Mechanical Low Back Pain Clinical Trial

Official title:

Influence of Patient-Informed Choice in a Novel Treatment Model for LBP: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01744015
• Other study ID #: 6291965
• Secondary ID: WalshU1
• Status: Withdrawn
• Phase: N/A
• First received: December 2, 2012
• Last updated: July 9, 2013
• Start date: April 2013
• Est. completion date: July 2016

Study information

• Verified date: December 2012
• Source: Walsh University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back Pain
• Mechanical Low Back Pain

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Proaxis Physical Therapy	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Walsh University	Proaxis Therapy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numeric Pain Rating Scale	At D/C, we will compare pain change scores	participants will be followed for the duration of the treatment which is on average 4 weeks	No
Primary	Care Seeking Behavior (recurrence of back pain) at 1 year	Care seeking behavior is defined as a recurrence of symptoms, no resolution of symptoms at 1 year	1 year status post discharge from formal physical therapy care	No
Secondary	Oswestry Disability Index	At discharge (after care) the Oswestry will be measured and compared	participants will be followed for the duration of the treatment which is on average 4 weeks	No