Clinical trial NCT00908102: Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials
Official title: The Prevalence of Low Back Symptoms in a Finnish Forestry Company - Effectiveness of Primary Care Interventions for Non-acute Low Back Symptoms in Occupational Health. Two Separate Randomised Controlled Trials (RCT) of Various Levels.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain, Recurrent
Low Back Pain
Keywords: low back pain
recurrent
subacute
secondary prevention
primary care
occupational health
back book
rehabilitation
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: University of Oulu
name: Juho Vainio Foundation
name: Finnish Cultural Foundation
name: Yrjo Jahnsson Foundation
name: Finnish Work Environment Fund
First posted: 2009-05-25
Enrollment: 505
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is:

* Epidemiological part: characteristics of low back pain patients from a forestry company in Finland. Data is collected from occupational health databases and self administered questionnaires.
* Intervention: To determine the effectiveness and cost-effectiveness of several different interventions in subacute low back pain (LBP) patients in occupational health (OH).

Detailed description: Eligible subjects were divided into two randomised controlled trials with the name of "mild" or "moderate" low back pain trials (interventions) and also mild vs natural course (NC) and moderate vs. NC interventions.

Pain, disability and quality of life were collected up to 2 years by self-administered questionnaires and sickness absences were gathered from electronical records for at least 4 year's follow up time.

Eligibility criteria: Inclusion Criteria:

* age 18-56 years
* present employment at the company
* at least one criteria out the following qualified for the study:

  * nonspecific LBP with the duration of 2 weeks or more
  * radiating, present low back pain
  * recurrent LBP (2 or more episodes per year)
  * work absence because of LBP
* included subjects also responded having low back pain during preceding week prior to the questionnaire (VAS ≥ 10 mm, Visual Analogue Scale 0-100 mm)

According to pain level, patients were later divided into two separate RCT's, "mild": VAS 10mm - 34mm, "moderate": VAS 35mm or more.

Exclusion Criteria:

* retirement
* acute nerve root compression symptoms
* malignant tumor
* recent fracture
* severe osteoporosis
* other specific disease preventing participation in the follow-up

Primary outcomes:
measure: Sickness absence days (Low back (LB) specific, other than LB, total)
timeFrame: 6, 12, 24, 36, 48 months
measure: Low back pain (VAS)
timeFrame: 0, 3, 6, 12, 24 months
measure: Disability (Roland Morris 18)
timeFrame: 0, 3, 6, 12, 24 months
measure: Quality of Life (15-D)
timeFrame: 0, 3, 6, 12, 24 months
Secondary outcomes:
measure: Sickness absence periods
timeFrame: 6, 12, 24, 36, 48 months
measure: Disability (Oswestry's index)
timeFrame: 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
Study officials:
affiliation: Evalua Finland Co.
name: Simo Taimela, MD, docent
role: STUDY_DIRECTOR
affiliation: University of Oulu
name: Jaro Karppinen, MD,professor
role: STUDY_DIRECTOR
affiliation: South Karelian Central Hospital
name: Markku Hupli, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Helsinki
name: Jarmo O Rantonen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Finnish Institute for Health and Welfare
name: Antti Malmivaara, MD, PhD
role: STUDY_DIRECTOR
affiliation: South Karelian Central Hospital
name: Satu Luoto, MD
role: STUDY_DIRECTOR
References:
citation: Rantonen J, Karppinen J, Vehtari A, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Effectiveness of three interventions for secondary prevention of low back pain in the occupational health setting - a randomised controlled trial with a natural course control. BMC Public Health. 2018 May 8;18(1):598. doi: 10.1186/s12889-018-5476-8.
citation: Rantonen J, Karppinen J, Vehtari A, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Cost-effectiveness of providing patients with information on managing mild low-back symptoms in an occupational health setting. BMC Public Health. 2016 Apr 12;16:316. doi: 10.1186/s12889-016-2974-4.
citation: Rantonen J, Vehtari A, Karppinen J, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Face-to-face information combined with a booklet versus a booklet alone for treatment of mild low-back pain: a randomized controlled trial. Scand J Work Environ Health. 2014 Mar;40(2):156-66. doi: 10.5271/sjweh.3398. Epub 2013 Nov 1.
citation: Rantonen J, Luoto S, Vehtari A, Hupli M, Karppinen J, Malmivaara A, Taimela S. The effectiveness of two active interventions compared to self-care advice in employees with non-acute low back symptoms: a randomised, controlled trial with a 4-year follow-up in the occupational health setting. Occup Environ Med. 2012 Jan;69(1):12-20. doi: 10.1136/oem.2009.054312. Epub 2011 May 20.