Condition category
Musculoskeletal Diseases
Date applied
04/04/2019
Date assigned
13/05/2019
Last edited
17/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Anna-Sofia Simula

ORCID ID

http://orcid.org/0000-0003-0796-4892

Contact details

Center for Life Course Health Research
P.O.Box 8000
Oulu
50100
Finland
+358 294 48 0000
anna.simula@oulu.fi

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

109/2016

Study information

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.

Acronym

Booklet For Back

Study hypothesis

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

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

Study design

Cluster randomized controlled study.

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measure

1. Change in Oswestry disability index (ODI) from baseline to the 12-month follow-up
2. Number of imaging examinations due LBP over the 3-month follow up.

Secondary outcome measures

1. Pain and disability: Oswestry disability Index, change from baseline to 12-month follow-up
2. Roland Morris disability questionnaire change from baseline to 12-month follow-up
3. PROMIS (Patient-Reported Outcomes Measurement Information System) (short form 20a) change from baseline to 3- and 12-month follow-ups
4. Frequency of LBP during past 3 months change from baseline to 3- and 12-month follow-ups
5. LBP intensity (NRS) during past week change from baseline to 3- and 12-month follow-ups
6. Leg pain intensity (NRS) during past week change from baseline to 3- and 12-month follow-ups
7. SBST (STarT Back screening tool) change from baseline to 12-month follow-up.
8. Health-related quality of life: EQ-5D (EuroQol five dimensions) change from baseline to 12-month follow-up.
9. Direct costs:
9.1 Physician visit during past year
9.2 Physiotherapist visits during past year
9.3 Nurse visits during past year
9.4 Other health care professional visits (e.g. psychologist) during past year
9.5 Imaging due to LBP (x-ray/MRI/CT) during past year
9.6 Pain medication over the first year and 3 years
9.7 Back operation and other invasive procedures.
10. Indirect costs:
10.1 Days on sick leave during past year (LBP-related and All)
10.2 Disability pensions over the first year and at 3 years.

Overall trial start date

13/04/2017

Overall trial end date

31/12/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18-65 years of age
2. LBP with or without radicular pain

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Sample size was calculated for 6 clusters. At the beginning, we planned all 6 clusters from ESSOTE area. Recruitment in small health care units did not run expectedly and therefore more health care areas were included. Other areas are Rovaniemi, EKSOTE I and EKSOTE II, Kerava and Hyvinkää. For the sample size calculation we used web based calculator for Inference for Means: Comparing Two Independent Samples: https://www.stat.ubc.ca/~rollin/stats/ssize/n2.html. Common standard deviation of ODI was 15% (evaluated using preliminary data of this study). Type I error rate is 0.05. A sample size of 284 patients would enable detection of difference of 5% in ODI given 80% power. With a 30% drop-out the final sample size is 406 patients. At baseline, imaging rate is approximately 35%. A sample size of 276 patients would enable detection of 15% decrease in relative imaging proportion given 80% power (type I error 0.05). Sample size 406 is sufficient.

Participant 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.

Recruitment start date

13/04/2017

Recruitment end date

30/05/2020

Locations

Countries of recruitment

Finland

Trial participating centre

Etelä-Savo Social and Health Care District (Essote)
Porrassalmenkatu 35-37
Mikkeli
50100
Finland

Trial participating centre

South Karelia Social and Health Care District (Eksote)
Valto Käkelän katu 3
Lappeenranta
35130
Finland

Trial participating centre

Rovaniemi primary health care
Hallituskatu 7, PL 8216
Rovaniemi
96101
Finland

Trial participating centre

Kerava primary health care
Metsolantie 2
Kerava
04200
Finland

Trial participating centre

Keski-Uudenmaan sote -kuntayhtymä
PL 46
Hyvinkää
05801
Finland

Sponsor information

Organisation

Center for Life Course Health Research, Faculty of Medicine

Sponsor details

P.O. Box 5000
University of Oulu
Oulu
90014
Finland
+358 294 48 0000
jaro.karppinen@oulu.fi

Sponsor type

University/education

Website

https://www.oulu.fi/medicine/elite

Funders

Funder type

Hospital/treatment centre

Funder name

Department of General Medicine Mikkeli Central Hospital (Essote), Mikkeli, Finland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Suomen Kulttuurirahasto

Alternative name(s)

Finnish Cultural Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Finland

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/05/2019: Internal review. 08/04/2019: Trial’s existence confirmed by IRB.