MOBile Instruction for Low Back Pain (MOBIL)

Low Back Pain Clinical Trial

— MOBIL  

Official title:

Brief Mobile Education at the Point of Care to Influence Healthcare Decisions Related Low Back Pain Management in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777983
• Other study ID #: C.2015.029
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2018
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to measure the impact of a short educational session on outcomes for patients consulting in primary care for low back pain. Subjects will be patients consulting to their primary care provider for a primary complaint and new episode of low back pain. Subjects will be randomized to receiving the educational tool versus usual care (information only without an educational component) in the clinic immediately prior to seeing their PCP. Patients will be followed for a 6-month period, and outcome measures will be collected and compared across both groups.

Description:

Patients that arrive for an initial evaluation for low back pain will be randomized to either receive the video education via an application (app) on a tablet computer, or usual care (which consists of information in the form of a handout but no further education prior to seeing the Primary Care Provider - PCP). To control for exposure to the tablet computer, subjects in both groups will use the tablet computer to fill out the self-reported outcome measures.

This will all take place while the patient is waiting to see their PCP, who will be blinded to the educational intervention that the patient received. After enrollment and completion of baseline outcome measures and surveys, the subject will be randomized to one of the 2 arms, receive the intervention, and then proceed to have their appointment with their PCP. The appointment with the PCP will proceed per usual care standards, with no additional research interventions. The subjects will be contacted for a follow-up at 1 and 6 months for assessment of self-reported outcomes measuring pain, function, and disability. The investigators will also abstract healthcare utilization from claims data and compare variables of healthcare use between both groups over the 6-month period following enrollment (radiographs, MRIs, prescription opioids, and specialty referrals).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. A Tricare beneficiary with a primary complaint of low back pain consulting in a primary care clinic

2. Between the age of 18 - 50 years

3. Read and speak English well enough to interact with the mobile education technology, provide informed consent and follow study instructions

Exclusion Criteria:

1. History of prior surgery to the lumbosacral spine

2. Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease

3. Known current pregnancy or history of pregnancy in the last 6 months

4. Already seen in primary care for an episode of low back pain within the last 3 months

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Educational Video App
The content of the app will be grounded in a biopsychosocial model and modeled on the Back Book, a booklet developed to help modify beliefs and behavior of patients with LBP. Essentially this will take the primary concepts and ideas often given in print or verbal form, and present it in a more engaging and dynamic fashion.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine (Phila Pa 1976). 1999 Dec 1;24(23):2484-91. — View Citation

Cherkin D, Deyo RA, Berg AO. Evaluation of a physician education intervention to improve primary care for low-back pain. II. Impact on patients. Spine (Phila Pa 1976). 1991 Oct;16(10):1173-8. — View Citation

Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. Erratum in: Ann Intern Med. 2008 Feb 5;148(3):247-8. — View Citation

Darlow B, Fullen BM, Dean S, Hurley DA, Baxter GD, Dowell A. The association between health care professional attitudes and beliefs and the attitudes and beliefs, clinical management, and outcomes of patients with low back pain: a systematic review. Eur J Pain. 2012 Jan;16(1):3-17. doi: 10.1016/j.ejpain.2011.06.006. Review. — View Citation

Foster NE, Delitto A. Embedding psychosocial perspectives within clinical management of low back pain: integration of psychosocially informed management principles into physical therapist practice--challenges and opportunities. Phys Ther. 2011 May;91(5):790-803. doi: 10.2522/ptj.20100326. Epub 2011 Mar 30. Review. — View Citation

George SZ, Childs JD, Teyhen DS, Wu SS, Wright AC, Dugan JL, Robinson ME. Brief psychosocial education, not core stabilization, reduced incidence of low back pain: results from the Prevention of Low Back Pain in the Military (POLM) cluster randomized trial. BMC Med. 2011 Nov 29;9:128. doi: 10.1186/1741-7015-9-128. — View Citation

Godges JJ, Anger MA, Zimmerman G, Delitto A. Effects of education on return-to-work status for people with fear-avoidance beliefs and acute low back pain. Phys Ther. 2008 Feb;88(2):231-9. Epub 2007 Dec 4. — View Citation

Moore JE, Von Korff M, Cherkin D, Saunders K, Lorig K. A randomized trial of a cognitive-behavioral program for enhancing back pain self care in a primary care setting. Pain. 2000 Nov;88(2):145-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare Utilization	This will include an a frequency count of diagnostic imaging orders and types, specialty referrals, and medication use (primarily prescription opiates).	6 months
Secondary	Patient Reported Outcomes Measurement Information System 29 Item Subscale (PROMIS-29)	The PROMIS 29-item short form efficiently assesses several outcomes important to patients with a neuromusculoskeletal injury, including pain intensity and interference, sleep disturbance, anxiety, depression, fatigue, and social role participation using items developed with rigorous methodology and patient input. The PROMIS-29 scores have been found valid for patients with orthopedic injuries with minimal clinically important change thresholds of 2-4 points for most scales. It has also been used to successfully measure psychosocial resiliency in patients with disability.	0, 1, 6 months
Secondary	Keele STarT Back Screening Tool (SBST)	The Keele STarT Back Screening Tool classifies patients into one of three risk categories (low, medium, and high) for targeted treatment, based on the presence of potentially modifiable physical and psychological prognostic indicators for persistent, disabling symptoms, identified through 9 questions. Patients are classified as "low risk" of future disabling LBP if they score positively on fewer than 4 questions. The remainder are then subdivided into "medium risk" (physical and psychosocial indicators for poor outcome, but without high levels of psychological indicators) and "high risk" (high levels of psychological prognostic indicators with or without physical indicators).	0, 1, 6 months
Secondary	Optimal Screening for Prediction of Referral and Outcome Yellow Flags assessment tool (OSPRO-YF)	Measures of psychosocial risk factors taken early after injury and sequentially over time represent an important and relevant clinical necessity, as psychosocial risk factors can vary over time. Some preliminary work on how sequential assessment may improve predictive capabilities has been performed. In previous studies of the SBST, baseline risk status was compared to prediction from 4-week risk status, and 4-week change in risk status for prediction of 6 month pain and disability outcomes following low back pain. The results indicated that prediction improved when 4-week risk status or 4-week change in risk status was incorporated into predictive models. In particular, those with worsened 4 week change in psychosocial risk status (i.e. increasing pain associated distress) had notably worse 6 month outcomes. This provides promising preliminary data for investigating how these change patterns influence patient outcomes in patients with low back pain.	0, 1, 6 months