Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials

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ClinicalTrials.gov Identifier: NCT00908102

Recruitment Status : Unknown

Verified March 2015 by Jarmo Rantonen, University of Helsinki.
Recruitment status was: Active, not recruiting

First Posted : May 25, 2009

Last Update Posted : March 18, 2015

Sponsor:

Collaborators:

University of Oulu

Juho Vainio Foundation

Finnish Cultural Foundation

Yrjo Jahnsson Foundation

Finnish Work Environment Fund

Information provided by (Responsible Party):

Jarmo Rantonen, University of Helsinki

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Low Back Pain, Recurrent Low Back Pain	Other: Moderate Other: Mild Other: Mild vs. NC Other: Moderate vs. NC	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	505 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
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 Start Date :	September 2001
Actual Primary Completion Date :	September 2008
Estimated Study Completion Date :	December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: BB Subjects received the back book booklet, which is an self-information booklet about managing low back symptoms. Included in the Mild and Mild vs. NC interventions.	Other: Mild A one level intervention with long-term effectiveness and cost-effectiveness was executed for patients suffering from non-acute mild level LBP in occupational health. Patients were selected by using a self-administered postal questionnaire. Other: Mild vs. NC A two level intervention with long-term effectiveness and cost-effectiveness was executed for patients suffering from non-acute mild level LBP in occupational health. Intervention arms were compared to NC - no intervention group.
Experimental: BB+A Subjects received a back book booklet and also oral advice based on the back book by the occupational health professional (OH Nurse or OH Physician in mild or moderate intervention, respectively). Included in the Mild and Mild vs. NC interventions. Arm was also used as a control at the Moderate and Moderate vs. NC interventions.	Other: Moderate A two level active intervention with a control group was executed for patients suffering from non-acute, moderate LBP in occupational health. Patients were selected by using a self-administered postal questionnaire. Other: Mild A one level intervention with long-term effectiveness and cost-effectiveness was executed for patients suffering from non-acute mild level LBP in occupational health. Patients were selected by using a self-administered postal questionnaire. Other: Mild vs. NC A two level intervention with long-term effectiveness and cost-effectiveness was executed for patients suffering from non-acute mild level LBP in occupational health. Intervention arms were compared to NC - no intervention group. Other: Moderate vs. NC A three level intervention with two control groups was executed for patients suffering from non-acute, moderate LBP in occupational health. RCT intervention groups were compared to NC group - i.e. no intervention.
Experimental: DBC A graded activity back school program was carried out in a physiotherapy out-patient clinic that consisted of one-hour session twice or three times per week, lasting for 12 weeks, supervised by a specially trained physiotherapist. Arm is included in the MOderate and Moderate vs. NC interventions.	Other: Moderate A two level active intervention with a control group was executed for patients suffering from non-acute, moderate LBP in occupational health. Patients were selected by using a self-administered postal questionnaire. Other: Moderate vs. NC A three level intervention with two control groups was executed for patients suffering from non-acute, moderate LBP in occupational health. RCT intervention groups were compared to NC group - i.e. no intervention.
Experimental: PMU An intensive, multidisciplinary LBP rehabilitation program was carried out in a physical medicine out-patient unit at the local Central Hospital. The program included a 3-week pre-course of 1,5 hour session at 3 days per week, closely followed by a 3-week intensive rehabilitation course of 6.5 hours per day for 5 days per week. A personal graded activity training program was made for each subject and patients were later called for follow-up visit within 1 year of the initial course. Arm is included in the MOderate and Moderate vs. NC interventions.	Other: Moderate A two level active intervention with a control group was executed for patients suffering from non-acute, moderate LBP in occupational health. Patients were selected by using a self-administered postal questionnaire. Other: Moderate vs. NC A three level intervention with two control groups was executed for patients suffering from non-acute, moderate LBP in occupational health. RCT intervention groups were compared to NC group - i.e. no intervention.
Placebo Comparator: NC Natural course of low back pain	Other: Mild vs. NC A two level intervention with long-term effectiveness and cost-effectiveness was executed for patients suffering from non-acute mild level LBP in occupational health. Intervention arms were compared to NC - no intervention group. Other: Moderate vs. NC A three level intervention with two control groups was executed for patients suffering from non-acute, moderate LBP in occupational health. RCT intervention groups were compared to NC group - i.e. no intervention.

Outcome Measures

Primary Outcome Measures :

Sickness absence days (Low back (LB) specific, other than LB, total) [ Time Frame: 6, 12, 24, 36, 48 months ]
Low back pain (VAS) [ Time Frame: 0, 3, 6, 12, 24 months ]
Disability (Roland Morris 18) [ Time Frame: 0, 3, 6, 12, 24 months ]
Quality of Life (15-D) [ Time Frame: 0, 3, 6, 12, 24 months ]

Secondary Outcome Measures :

Sickness absence periods [ Time Frame: 6, 12, 24, 36, 48 months ]
Disability (Oswestry's index) [ Time Frame: 3, 6, 12, 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 56 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908102

Locations

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Finland
University of Helsinki
Helsinki, Finland, 00100

Sponsors and Collaborators

University of Helsinki

University of Oulu

Juho Vainio Foundation

Finnish Cultural Foundation

Yrjo Jahnsson Foundation

Finnish Work Environment Fund

Investigators

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Study Director:	Simo Taimela, MD, docent	Evalua Finland Co.
Study Director:	Jaro Karppinen, MD,professor	University of Oulu
Study Director:	Markku Hupli, MD, PhD	South Karelian Central Hospital
Principal Investigator:	Jarmo O Rantonen, MD	University of Helsinki
Study Director:	Antti Malmivaara, MD, PhD	Finnish Institute for Health and Welfare
Study Director:	Satu Luoto, MD	South Karelian Central Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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Responsible Party:	Jarmo Rantonen, MD, University of Helsinki
ClinicalTrials.gov Identifier:	NCT00908102
Other Study ID Numbers:	A18/01
First Posted:	May 25, 2009 Key Record Dates
Last Update Posted:	March 18, 2015
Last Verified:	March 2015

Keywords provided by Jarmo Rantonen, University of Helsinki:


low back pain recurrent subacute secondary prevention	primary care occupational health back book rehabilitation

Additional relevant MeSH terms:

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Back Pain Low Back Pain Pain Neurologic Manifestations

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