MOBile Instruction for Low Back Pain (MOBIL)

NCT02777983 | Completed

• 1 other identifier: C.2015.029
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

patient education; low back pain; technology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient Reported Outcomes Measurement Information System 29 Item Subscale (PROMIS-29)

  0, 1, 6 months

• Keele STarT Back Screening Tool (SBST)

  0, 1, 6 months

• Optimal Screening for Prediction of Referral and Outcome Yellow Flags assessment tool (OSPRO-YF)

  0, 1, 6 months

Study Arms (2)

Education Group

EXPERIMENTAL

This will consist of a 6-minute educational video app created and delivered within an application (mobile app) that will be interactive in nature, asking multiple-choice questions at the end to help reinforce key points of the video message. It will include self-management guidance based on evidence related to activity, exercise, and other behavioral components known to influence the prognosis of low back pain. Subjects will also receive the 1-page general conditioning handout that the usual care group will receive.

Behavioral: Educational Video App

Usual Care Group

NO INTERVENTION

Subjects randomized to usual care will receive a 1-page generic informational handout on general conditioning recommended for low back pain, in addition to whatever education the subject's PCP decides to provide.

Interventions

Educational Video App BEHAVIORAL

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.

Also known as: Mobile Technology Education

Education Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A Tricare beneficiary with a primary complaint of low back pain consulting in a primary care clinic
• Between the age of 18 - 50 years
• Read and speak English well enough to interact with the mobile education technology, provide informed consent and follow study instructions

You may not qualify if:

• History of prior surgery to the lumbosacral spine
• Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease
• Known current pregnancy or history of pregnancy in the last 6 months
• Already seen in primary care for an episode of low back pain within the last 3 months

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

Location

Related Publications (9)

• 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. doi: 10.7326/0003-4819-147-7-200710020-00006.

  PMID: 17909209 BACKGROUND

• 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.

  PMID: 22126534 BACKGROUND

• 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.

  PMID: 21719329 BACKGROUND

• 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.

  PMID: 21451095 BACKGROUND

• 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. doi: 10.2522/ptj.20050121. Epub 2007 Dec 4.

  PMID: 18056753 BACKGROUND

• 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. doi: 10.1097/00007632-199912010-00010.

  PMID: 10626311 BACKGROUND

• 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. doi: 10.1097/00007632-199110000-00008.

  PMID: 1836677 BACKGROUND

• 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):145-153. doi: 10.1016/S0304-3959(00)00314-6.

  PMID: 11050369 BACKGROUND

• Rhon DI, Mayhew RJ, Greenlee TA, Fritz JM. The influence of a MOBile-based video Instruction for Low back pain (MOBIL) on initial care decisions made by primary care providers: a randomized controlled trial. BMC Fam Pract. 2021 Oct 9;22(1):200. doi: 10.1186/s12875-021-01549-y.

  PMID: 34627152 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Rhon, DPT, DSc

  Brooke Army Medical Center; Baylor University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Physical Therapy, Center for the Intrepid

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: DHA usually approves Data Sharing Agreements for up to 1 year at a time
• Access Criteria: Requires a Data Sharing Agreement Application to be submitted through the US Defense Health Agency

Locations

US (1)