Low Back PainNCT04819009
Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization
An observational study of Low Back Pain, run by Ariel University at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- the Enhanced Transtheoretical Model Intervention (ETMI)
- How many people
- 1,463 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2022to 2 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization- an Implementation Study
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.
Read the detailed description
An implementation study- a prospective cohort study with pre- and post-intervention by retrieving economic and therapeutic outcome data from MHS databases. The intervention group will be the Central District of MHS, among 220 primary care practitioners (100 Physicians and 120 physiotherapists) and their patients (n=7,000) who suffer from back pain and receive treatment. We will investigate the relationship between the care received and outcomes in terms of healthcare utilization, costs, and patient-relevant outcomes.
- Conditions
- Low Back Pain
- Being tested
- the Enhanced Transtheoretical Model Intervention (ETMI)
- Keywords
- Low Back Pain, implementation study, Enhanced Transtheoretical Model Intervention, Public Health
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- Creating a therapeutic alliance (communication skills and reassurance)
- 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.")
- Exposure to brisk walking (brisk walking in the corridor, hand by hand with the therapist) and graded activity.
- Postcard with reminder messages on how to self manage the back.
| Study group | Role | What they receive |
|---|---|---|
| Central District | The ETMI method will be implemented in this group Receives: Other: the Enhanced Transtheoretical Model Intervention (ETMI) | |
| North District | control | |
| Hasharon District | control | |
| South District | control | |
| Jerusalem and Hasfhela District | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETMI Code
Measured: baseline
Secondary outcomes (1)
Lumbar Computerized Adaptive Test (LCAT)
LCAT is a computerized adaptive test, meaning that the administration selects items from the item bank one at a time based on an administrative algorithm. The final calculated functional score ranges on a linear scale of 0-100, higher measures representing higher function. Additionally, the system predicts a risk-adjusted functional score at discharge. The adjusting is on: functional score at admission, age, sex, chronicity as number of days from onset of the treated condition, number of related surgeries, exercise history and use of medication to treat LBP.MCID for the LCAT is 3-9 points depending on the first score. LCAT has been tested for validity by comparing it to the Oswestry Low Back Pain Disability Questionnaire and has a high level of reliability in the English version (α = 0.92).Several studies have been published using the LCAT's Hebrew version.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Jan 2022
- Primary completion30 Aug 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Responsible party
- Sponsor
- Investigators
- Ron Feldman, PhD Candidate, Principal investigator, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819009
- Sponsor's protocol ID
- ArielURF
- Status last verified
- Jan 2023
- First submitted
- 18 Mar 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the result of the study will be analyzed. a paper will be submitted to an international journal with study description including methods, examination protocol results.
Publications
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.
PubMed 28142364Canaway 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.
PubMed 29643158Simoneau GG. 2017 JOSPT Award Recipients. J Orthop Sports Phys Ther. 2018 May;48(5):348. doi: 10.2519/jospt.2018.0104.
PubMed 29712542
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization- an Implementation Study
- ClinicalTrials.gov ID
- NCT04819009
- Acronym / sponsor ID
- ArielURF
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, implementation study, Enhanced Transtheoretical Model Intervention, Public Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,463 participants (actual)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An implementation study- a prospective cohort study with pre- and post-intervention by retrieving economic and therapeutic outcome data from MHS databases. The intervention group will be the Central District of MHS, among 220 primary care practitioners (100 Physicians and 120 physiotherapists) and their patients (n=7,000) who suffer from back pain and receive treatment. We will investigate the relationship between the care received and outcomes in terms of healthcare utilization, costs, and patient-relevant outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Central District | – | Other: the Enhanced Transtheoretical Model Intervention (ETMI)The ETMI method will be implemented in this group |
| North District | – | –control |
| Hasharon District | – | –control |
| South District | – | –control |
| Jerusalem and Hasfhela District | – | –control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Enhanced Transtheoretical Model Intervention (ETMI)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. | Other | Central District |
Primary outcome
ETMI Code
Time frame: baseline
1 secondary outcome
Lumbar Computerized Adaptive Test (LCAT)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 28142364Ben-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.
- Background: PubMed 29643158Canaway 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.
- Background: PubMed 29712542Simoneau GG. 2017 JOSPT Award Recipients. J Orthop Sports Phys Ther. 2018 May;48(5):348. doi: 10.2519/jospt.2018.0104.
- Individual participant dataSharing planned: Yes. the result of the study will be analyzed. a paper will be submitted to an international journal with study description including methods, examination protocol results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Feldman, PhD Candidate principal investigator
Ariel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Ariel University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ETMI Code (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04819009, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.