The patient education booklet as part of low back pain (LBP) care in primary care compared with best current care.
| ISRCTN | ISRCTN14389368 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14389368 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 109/2016 |
| Sponsor | University of Oulu Center for Life Course Health Research |
| Funders | Department of General Medicine Mikkeli Central Hospital (Essote), Mikkeli, Finland, Suomen Kulttuurirahasto |
- Submission date
- 04/04/2019
- Registration date
- 13/05/2019
- Last edited
- 01/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
For most patients with low back pain no serious or specific cause for pain can be demonstrated. International guidelines recommend a biopsychosocial approach for LBP care and avoidance of inappropriate imaging. Implementation of guidelines is insufficient. Inaccurate beliefs about LBP and inappropriate imaging is common.
Professionals describe patients´ wish for imaging as a barrier for following imaging guidelines, while the patients ask for an explanation for their pain. New evidence-based patient education including information about imaging guidelines, the nature of LBP, and appropriate management strategies has been developed. Use of the booklet during the consultation could help clinicians to support patients in their care, and facilitate better understanding of LBP and recovery. This booklet was translated into Finnish and the booklet will be used in this trial in the intervention.
Who can participate?
Anyone aged 18-years who has had low back pain for longer than two weeks can take part.
What does the study involve?
The study involves low back pain patient information and imaging policy. Participating requires 20min time to answer web-based questionnaire four times in 3 years.
What are the possible benefits and risks of participating?
Participating the study gives new knowledge and enables improvement of patient information in low back pain. There is no risk for individuals when participating this study.
Where is the study run from?
Etelä-Savo Social and Health Care District (Essote), Finland
When is the study starting and how long is it expected to run for?
April 2017 to May 2020
Who is funding the study?
1. Department of General Medicine Mikkeli Central Hospital (Essote), Mikkeli, Finland
2. The Finnish Cultural Foundation
Who is the main contact?
Anna Sofia Simula, anna.simula@oulu.fi
Contact information
Scientific
Center for Life Course Health Research
P.O.Box 8000
Oulu
50100
Finland
 ORCID ID |
0000-0003-0796-4892 |
|---|---|
| Phone | +358 294 48 0000 |
| anna.simula@oulu.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomized controlled study. |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | A cluster randomized clinical trial of the use of the patient education booklet as part of low back pain (LBP) care in primary care compared with best current care. |
| Study acronym | Booklet For Back |
| Study objectives | Implementation of the “Understanding Low back pain” patient education booklet to primary care will decrease imaging examinations due to LBP compared to best current care. Implementation of the “Understanding Low back pain” patient education booklet to primary care will improve the effectiveness of LBP care in the primary care compared to best current care. |
| Ethics approval(s) | Approved 23/01/2017, Ethics Committee of the University Hospital of Oulu (P.O.Box 8000, FI-90014 University of Oulu, Oulo, Finland; university.of.oulu@oulu.fi; +358 294 48 0000), ref: 109/2016 |
| Health condition(s) or problem(s) studied | Low back pain |
| Intervention | The intervention is a short 30 min education training session for physiotherapists and physicians containing the main themes and theory of the new patient education booklet. The booklet is provided for use as part of care for all LBP patients in the intervention health care units. The professionals are supposed to use the booklet during the appointment, but they can use it as they want. Otherwise the care will be provided as usual. Randomizing process: One cluster is one health care unit or health care area. Participant who visit intervention health care unit, include to intervention. Participants who visit control health care unit is automatically allocated to control. |
| Intervention type | Other |
| Primary outcome measure(s) |
Current primary outcome measure as of 30/10/2019: |
| Key secondary outcome measure(s) |
1. Pain and disability: Oswestry disability Index, change from baseline to 12-month follow-up |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 268 |
| Total final enrolment | 420 |
| Key inclusion criteria | 1. 18-65 years of age 2. LBP with or without radicular pain |
| Key exclusion criteria | 1. First patient-reported contact to health care due to LBP and episode has lasted less than 2 weeks 2. A suspicion of a serious cause for LBP or LBP requiring urgent care. |
| Date of first enrolment | 13/04/2017 |
| Date of final enrolment | 30/05/2020 |
Locations
Countries of recruitment
- Finland
Study participating centres
Mikkeli
50100
Finland
Lappeenranta
35130
Finland
Rovaniemi
96101
Finland
Kerava
04200
Finland
Hyvinkää
05801
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/09/2021 | 01/03/2024 | Yes | No | |
| Interim results article | interim results | 30/12/2019 | 02/01/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/03/2024: Publication reference added.
16/06/2020: The total final enrolment was added.
08/01/2020: Internal review.
02/01/2020: Publication reference added.
30/10/2019: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The target number of participants was changed.
3. The total target enrolment was changed from 406 to 268.
17/05/2019: Internal review.
08/04/2019: Trial’s existence confirmed by IRB.
