Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization

NCT04819009 | Completed

• 1 other identifier: ArielURF
• Study Type: observational
• Target: 1,463
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess whether the ETMI method can be implemented among primary care practitioners in the central district of Maccabi Health Services and examine whether it provides a medical and economic advantage.

Conditions

Low Back Pain

Keywords

Low Back Pain; implementation study; Enhanced Transtheoretical Model Intervention; Public Health

Outcome Measures

Primary Outcomes (1)

• ETMI Code

  baseline

Secondary Outcomes (1)

• Lumbar Computerized Adaptive Test (LCAT)

  baseline

Other Outcomes (8)

• Economic variables and therapeutic results

  baseline

• Numeric Pain Rate Scale (NPRS)

  baseline

• Fear Avoidance Belief Questionnaire (FABQ)

  baseline

Study Arms (5)

Central District

The ETMI method will be implemented in this group

Other: the Enhanced Transtheoretical Model Intervention (ETMI)

North District

control

Hasharon District

control

South District

control

Jerusalem and Hasfhela District

control

Interventions

the Enhanced Transtheoretical Model Intervention (ETMI) OTHER

ETMI consists of a physical and functional examination, a discussion about the role of physical activity matched to the patient stage of change, and guided through motivational interviewing techniques, exposure to fast walking, and goal setting. The patient receives a postcard outlining the main messages about physical activity and four simple stretches. The ETMI method consists of four parts: 1. Creating a therapeutic alliance (communication skills and reassurance) 2. Clear messages to the patient: Mandatory 3 sentences: (1." physical activity is the only thing that will help your back pain over time." 2. "It's easy to reduce your pain now - but the important thing is to prevent the next episode"," 3. "Your body must be strong and flexible.") 3. Exposure to brisk walking (brisk walking in the corridor, hand by hand with the therapist) and graded activity. 4. Postcard with reminder messages on how to self manage the back.

Central District

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

220 primary care practitioners (100 Physicians and 120 physiotherapists) and their patients (n=7,000) who suffer from back pain and receive treatment.

You may qualify if:

• primary care practitioners and their patients, who suffer from back pain and receive treatment.
• patients who suffer from back pain and receive treatment with or without leg radiation

Sponsors & Collaborators

• Ariel University: lead
• Maccabi Healthcare Services, Israel: collaborator

Study Sites (1)

Ariel University

Ariel, 40700, Israel

Location

Related Publications (3)

• Ben-Ami N, Chodick G, Mirovsky Y, Pincus T, Shapiro Y. Increasing Recreational Physical Activity in Patients With Chronic Low Back Pain: A Pragmatic Controlled Clinical Trial. J Orthop Sports Phys Ther. 2017 Feb;47(2):57-66. doi: 10.2519/jospt.2017.7057.

  PMID: 28142364 BACKGROUND

• Canaway A, Pincus T, Underwood M, Shapiro Y, Chodick G, Ben-Ami N. Is an enhanced behaviour change intervention cost-effective compared with physiotherapy for patients with chronic low back pain? Results from a multicentre trial in Israel. BMJ Open. 2018 Apr 10;8(4):e019928. doi: 10.1136/bmjopen-2017-019928.

  PMID: 29643158 BACKGROUND

• Simoneau GG. 2017 JOSPT Award Recipients. J Orthop Sports Phys Ther. 2018 May;48(5):348. doi: 10.2519/jospt.2018.0104.

  PMID: 29712542 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Ron Feldman, PhD Candidate

  Ariel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 26, 2021
• Study Start: January 1, 2022
• Primary Completion: August 30, 2023
• Study Completion: January 2, 2024
• Last Updated: January 31, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: one year following completion of study

Locations

IL (1)