An observational study in Low Back Pain, sponsored by Ariel University. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Ariel University · Observational
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 1,463 is above the median of 100 across 357 observational studies indexed under Back Pain.
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220 primary care practitioners (100 Physicians and 120 physiotherapists) and their patients (n=7,000) who suffer from back pain and receive treatment.
Exclusion Criteria:
The ETMI method will be implemented in this group
Other: the Enhanced Transtheoretical Model Intervention (ETMI)
control
control
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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.
ETMI Code
Time frame: baseline
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.
Time frame: baseline
Economic variables and therapeutic results
Number of primary care clinician appointments
Time frame: baseline
Numeric Pain Rate Scale (NPRS)
The patient is asked to rate his pain intensity in the last 24 hours on a scale of 0-10 (10=severest pain)
Time frame: baseline
Fear Avoidance Belief Questionnaire (FABQ)
It is a modification to the original version, allowing for the assessment using an Item Response Theory-based measures replacing the summative methods. The later version consists of three items, scoring 0-100, with 100 representing higher fear-avoidance, and 44 being a cut-off point between high and low values
Time frame: baseline
Economic variables and therapeutic results
Number of orthopedic clinician appointments
Time frame: baseline
Economic variables and therapeutic results
Number of physiotherapy appointments
Time frame: baseline
Economic variables and therapeutic results
Anti-inflammatory drug dosage
Time frame: baseline
Economic variables and therapeutic results
Number of imaging tests
Time frame: baseline
Economic variables and therapeutic results
Number of surgeries and procedures
Time frame: baseline
Plan to share: 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.
Supporting information: Study protocol, Csr
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Ariel University