Condition category
Musculoskeletal Diseases
Date applied
22/04/2019
Date assigned
13/05/2019
Last edited
13/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Low back pain (LBP) is a complex condition in which biological, psychological, and social factors impact on both the experience of back pain and associated disability. For the vast majority of people with LBP, it is not possible to accurately identify the specific cause. Most people with new episodes of LBP recover quickly; however, recurrence is common and in a small proportion LBP becomes persistent and disabling.
In 2005, a multidimensional biopsychosocially oriented approach to assessment and management strategy LBP was proposed. This approach broadly focuses on personalised pain education, fear reduction, functional activation and adopting healthy lifestyle behaviours for people where serious pathology has been ruled out. The dose of the intervention is tailored to the patient presentation. This cognitive functional approach has been shown to demonstrate superior outcomes compared with the best evidence-based usual care strategy, consisting of manual therapy and exercises, at 12-month follow-up.

The aim of this study is to investigate whether a biopsychosocially oriented approach to LBP leads to improvement of patients’ disability at 1 year compared to usual care in occupational health care units. We will also evaluate whether this approach is implemented in the intervention group units 1 year after the recruitment of the last patient and we will interview qualitatively the professionals of the intervention units in order to describe facilitators and barriers to the new treatment approach in occupational health care.

Who can participate?
All patients 18-65 years of age contacting health care due LBP with or without radicular pain were included in the study.

What does the study involve?
Patients will either be treated using the Start Back Tool or receive treatment as usual depending on the health care unit that they visit. Participating requires 20-min time for answering the web-based questionnaire four times over 3 years.

What are the possible benefits and risks of participating?
Patients participating the study are given new knowledge about their pain, which enables improvement of low back pain management. There are no risks for individuals with participation to this study.

Where is the study run from?
Center for Life Course Health Research, University of Oulu, Finland.

When is the study starting and how long is it expected to run for?
September 2017 to November 2018

Who is funding the study?
The Finnish Work Environment Fund (Työsuojelurahasto)

Who is the main contact?
Prof. Jaro Karppinen (scientific), jaro.karppinen@oulu.fi

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jaro Karppinen

ORCID ID

http://orcid.org/0000-0002-2158-6042

Contact details

BOX 5000
Oulu
90014
Finland
+358-414462859
jaro.karppinen@oulu.fi

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

79/2017 (protocol number of the Ethics Committee of the Northern Ostrobothnia Hospital District)

Study information

Scientific title

Effectiveness of biopsychosocially oriented management of low back pain in occupational health care

Acronym

Back works

Study hypothesis

The aim of this study is to investigate whether a biopsychosocially oriented approach to LBP leads to improvement of patients’ disability at 1 year compared to usual care in occupational health care units. We will also evaluate whether this approach is implemented in the intervention group units 1 year after the recruitment of the last patient and we will interview qualitatively the professionals of the intervention units in order to describe facilitators and barriers to the new treatment approach in occupational health care.

Ethics approval

Approved 19/09/2017, Ethics Committee of the University Hospital of Oulu (PPSHP:n alueellinen eettinen toimikunta, Yhtymähallinto N5 (1 krs.), PL 10, 90029 OYS, Finland; +358 40 773 1529; minna.makiniemi@ppshp.fi) ref: 79/2017

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 participant information sheet (available only in Finnish).

Condition

Low back pain

Intervention

Implementation of classification-based biopsychosocial approach for low back pain patients in occupational health care.

Professionals
The intervention consists of education of professionals with in-house courses and web-based material that enhanced adherence to the biopsychosocial individualized approach for LBP care, evidence-based information for patients (using the new patient information leaflet), avoidance of unnecessary imaging and harmful messages. To help utilize this approach participants were taught to use SBT (STarT Back Screening Tool) and the short version of ÖMPSQ (Örebro Musculoskeletal Pain Screening Questionnaire) as screening tools for LBP patients. We started with a 4-day training in September 2017 with the involvement of the world leading pain psychologist, Prof. Steven Linton. Additionally, an experienced trainer, musculoskeletal physiotherapist, Kasper Ussing from Denmark, guided the study physiotherapists (PT). This training consisted of the theoretical basis of biopsychosocial approach in low back pain management, pain education, psychological risk factors, physical factors and behavioral responses to pain, interview and assessment, and tailored individualized management for LBP. Live patient demonstrations, clinical case problem solving and role plays were used to enhance the learning. Two experienced Finnish PT’s (Mikko Lausmaa and Riikka Holopainen) supported the implementation by 1-2 coaching visits to each intervention unit. Additionally, we delivered a written educational package to other professionals participating in treatment of LBP patients in the participating units (nurses, psychologists).
Professionals were instructed to use SBT systematically and to make individual care plans for all LBP patients according to the risk profile. The patient education booklet, which is based on the biopsychosocial model, delivers evidence-based information on etiology of LBP and appropriate imaging to patients and also reminds professionals of the biopsychosocial model of LBP. The booklet is translated to Finnish. A two-days booster session was organized in June 2018.

Patient level
All LBP patients received the patient education booklet. Patients were classified to low-, moderate- or high-risk groups during the first visit in health care based on the SBT. Physicians and physiotherapists were instructed to plan the individual treatment process according to risk classification. The low-risk group: advice on pain medication if needed and patient education booklet based on biopsychosocial model. Medium-risk group: an evaluation by a physiotherapist in addition to the low-risk group intervention. High-risk group: similar treatment protocol as medium-risk patients but with emphasis on psychosocial factors and minimal delay for the therapy (preferably less than one week). For all patients, physiotherapists were supposed to evaluate patients’ pain, fears and maladaptive behaviors in addition to clinical examination and patient advice. Physiotherapy was supposed to be individualized and biopsychosocially oriented. The number of physiotherapy contacts was not limited but rather physiotherapists were advised to construct individual care plan taking into account patient´s ability/disability, possible barriers for recovery and personalized goals. Co-occurring symptoms and comorbidities were told to be taken into consideration and treated if needed. The physiotherapists were allowed to refer patients to other professionals such as occupational psychologists if needed.

Groups are formed using cluster randomization. One cluster is one health care unit or health care area. Participants who visit the intervention health care unit, are allocated to the intervention arm. Participants who visit control health care unit are automatically allocated to the control arm.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Change in Oswestry Disability Index (ODI) from baseline to 12-month follow-up.

Secondary outcome measures

1. Pain and disability:
1.1 Oswestry Disability Index, change from baseline to 3-month follow-up
1.2 Roland Morris disability questionnaire change from baseline to 12-month follow-up
1.3 PROMIS (Patient-Reported Outcomes Measurement Information System) (short form 20a) change from baseline to 3- and 12-month follow-ups
1.4 Frequency of LBP during past 3 months change from baseline to 3- and 12-month follow-ups
1.5 LBP intensity (NRS, numerical rating scale) during past week change from baseline to 3- and 12-month follow-ups
1.6 Leg pain intensity (NRS) during past week change from baseline to 3- and 12-month follow-ups
1.7 SBT (STarT Back Tool) change from baseline to 12-month follow-up.
2. Health-related quality of life: EQ-5D (EuroQol five dimensions) change from baseline to 12-month follow-up.
3. Direct costs:
3.1 Physician visits during past year
3.2 Physiotherapist visits during past year
3.3 Nurse visits during past year
3.4 Other health care professional visits (e.g. psychologist) during past year
3.5 Imaging due to LBP (x-ray/MRI/CT) during past year
3.6 Pain medication over the first year and 3 years; Back operations and other invasive procedures.
4. Indirect costs
4.1 Days on sick leave during past year (LBP-related and all)
4.2 Disability pensions over the first year and at 3 years

Overall trial start date

23/01/2017

Overall trial end date

31/12/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18 - 65 years of age
2. LBP with or without radicular pain
3. Signed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

According to power calculation (in a cluster randomized design), to obtain a 20% difference in the primary outcome (ODI) at 1 year with 80% power, a sample size of 600 is needed

Participant exclusion criteria

1. Age under 18 or over 65 years
2. Serious cause for LBP or LBP requiring urgent care

Recruitment start date

25/09/2017

Recruitment end date

29/11/2018

Locations

Countries of recruitment

Finland

Trial participating centre

Attendo Haukipudas
Teollisuustie 1
Haukipudas
90830
Finland

Trial participating centre

Attendo Imatra
Tainionkoskentie 68
Imatra
55120
Finland

Trial participating centre

Attendo Kemi
Rivinkarintie 68 C
Kemi
94800
Finland

Trial participating centre

Attendo Kempele
Voimatie 6 D
Kempele
90440
Finland

Trial participating centre

Attendo Kerava
Kultasepänkatu 8
Kerava
04250
Finland

Trial participating centre

Attendo Liminka
Kauppakatu 2
Liminka
91900
Finland

Trial participating centre

Attendo Loimaa
Heimolinnankatu 10
Loimaa
32200
Finland

Trial participating centre

Attendo Oulu Nuottasaari
Paperitehtaantie 1
Oulu
90120
Finland

Trial participating centre

Attendo Rovaniemi
Valtakatu 11
Rovaniemi
96100
Finland

Trial participating centre

Attendo Valkeakoski
Sääksmäentie 1
Valkeakoski
37600
Finland

Trial participating centre

Attendo Vantaa
Vernissakatu 6
Vantaa
01300
Finland

Trial participating centre

Mehiläinen Espoo
Mehiläinen Espoo Leppävaara Lääkärikeskus, Työterveysasema Hevosenkenkä 3, Panorama Tower
Espoo
02600
Finland

Trial participating centre

Mehiläinen Espoo Matinkylä
Lääkärikeskus, Työterveysasema Piispanportti 10 A, 3. krs
Espoo
02200
Finland

Trial participating centre

Mehiläinen Helsinki Forum
Lääkärikeskus, Työterveysasema Mannerheimintie 20 B, 4. krs
Helsinki
00100
Finland

Trial participating centre

Mehiläinen Helsinki Töölö
Lääkärikeskus, Sairaala, Työterveysasema Pohjoinen Hesperiankatu 17
Helsinki
00260
Finland

Trial participating centre

Mehiläinen Jyväskylä
Kauppakatu 35
Jyväskylä
40100
Finland

Trial participating centre

Mehiläinen Kokkola
Rantakatu 2 B
Kokkola
67100
Finland

Trial participating centre

Mehiläinen Kuopio
Kauppakatu 39 A
Kuopio
70100
Finland

Trial participating centre

Mehiläinen Oulu
Lääkärikeskus, Sairaala, Työterveysasema Kauppurienkatu 9
Oulu
90100
Finland

Trial participating centre

Mehiläinen Turku Artukainen Työterveys
Työterveysasema Pansiontie 45
Turku
20210
Finland

Trial participating centre

Mehiläinen Turku Kauppiaskatu
Lääkärikeskus, Työterveysasema Kauppiaskatu 8
Turku
20100
Finland

Trial participating centre

Mehiläinen Neo Turku
Lääkärikeskus, Sairaala, Työterveysasema Joukahaisenkatu 6, NEO-talo
Turku
20520
Finland

Trial participating centre

Työterveys Virta Lakeus
Työterveysasema Liminka Liminganraitti 10 C-talo 2. kerros
Liminka
91900
Finland

Trial participating centre

Työterveys Virta Oulu, Hallituskatu (Teletalo)
Työterveysasema Hallituskatu (Teletalo) Hallituskatu 36 A, 5. krs.
Oulu
90100
Finland

Trial participating centre

Työterveys Virta Oulu, Rehapolis
Työterveysasema Rehapolis Kiviharjunlenkki 6, 2 krs.
Oulu
90220
Finland

Trial participating centre

Terveystalo Kouvola
Tommolankatu 9
Kouvola
45130
Finland

Trial participating centre

Terveystalo Oulu
Albertinkatu 16/Sepänkatu 17
Oulu
90100
Finland

Trial participating centre

Terveystalo Tampere
Rautatienkatu 27
Tampere
33100
Finland

Trial participating centre

Terveystalo Tampere Tullintori
Hammareninkatu 2 B, 4 krs
Tampere
33100
Finland

Trial participating centre

Terveystalo Lahti Työterveys
Hämeenkatu Hämeenkatu 15
Lahti
15110
Finland

Trial participating centre

Terveystalo Varkaus
Terveystalo Varkaus Wredenkatu Wredenkatu 2
Varkaus
78250
Finland

Trial participating centre

Terveystalo Varkaus
Linjurikatu Linjurikatu 12
Varkaus
78200
Finland

Trial participating centre

Työplus Kokkola
Mariankatu 26
Kokkola
67200
Finland

Trial participating centre

Pohjola Sairaala Oulu
Kiilakivenkuja 1
Oulu
90250
Finland

Sponsor information

Organisation

Center for Life Course Health Research, University of Oulu

Sponsor details

Box 5000
Oulu
90014
Finland
+358 294 48 0000
university.of.oulu@oulu.fi

Sponsor type

University/education

Website

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

Funders

Funder type

Government

Funder name

Työsuojelurahasto

Alternative name(s)

Finnish Work Environment Fund

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Finland

Results and Publications

Publication and dissemination plan

The results of the trial will be published in peer-reviewed international journals. The results will be disseminated through conventional media and social media.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to national regulations.

Intention to publish date

31/05/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/04/2019: Trial’s existence confirmed by Ethics Committee of the University Hospital of Oulu.