CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
delivery of the low back pain bookletother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03953625
NCT03953625N/ACompleted

Interest of the Return to Primary Care of the "Low Back Booklet" of Health Insurance in the Recovery of Common Acute Low Back Pain

Fondation Hôpital Saint-Joseph·interventional·Posted May 16, 2019·Updated Mar 31, 2022

In Brief

A clinical study evaluating delivery of the low back pain booklet for Low Back Pain. Completed, enrolled 33 participants across 1 site.

Detailed Summary

Low back pain is defined as pain or functional discomfort between the twelfth rib and the gluteal fold, which may be median or lateralised. It can radiate up to the thigh but never below the knee. Low back pain is said to be acute if it has been progressing for less than three months. In the acute form, it evolves on a mechanical rhythm, prevents the usual activity and occurs preferably in adults aged 20 to 55 years. 90% of these low back pains are mechanical and common, i.e. characterized by the absence of "red flags ". The red flags refer to a group of characteristic clinical signs that should alert the practitioner to the possibility of an underlying serious spinal pathology and the need for further investigation. Common low back pain is a public health issue since it is the leading cause of health expenditure in Europe and an economic challenge (900 million euros / year and 19.1% of work stoppages in 2015 compared to 13% in 2005). In 80% of cases, the general practitioner is in the first line of care in cases of acute low back pain. Indeed, it represents a frequent reason for consultation in general medicine (2nd reason for consultation among general practitioners in 2015). The doctor must: track down warning signs that call into question the diagnosis of common low back pain (red flags), relieve and reassure the patient. Common low back pain very often heals spontaneously but about 10% of patients will develop chronic low back pain (persistence of pain for more than 3 months). These chronicized patients account for 80% of the total cost of low back pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 16, 2019
Enrollment StartNov 29, 2018
Primary CompletionMay 13, 2020
Study CompletionOct 26, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.1 years ago

Interventions

delivery of the low back pain bookletother

When a patient arrives at the GHPSJ emergency room or in general medical consultation at the CMT and a diagnosis of common acute low back pain is made, the physician verifies the study selection criteria. If it is randomized in the arm 2 "with booklet" group, the management will be the same as for the "without booklet" group but with the hand delivery of the booklet in addition. All patients will be informed about the existence of the booklet. A link to the digital version on the ameli.fr website is included in the information note The patient will be contacted 3 months later by a Clinical Research Associate (CRA) to conduct a data collection.