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

March 17, 2015 updated by: Jarmo Rantonen, University of Helsinki

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.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

505

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00100
        • University of Helsinki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 56 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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: 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
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: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Finnish Cultural Foundation
University of Oulu
Finnish Work Environment Fund
Juho Vainio Foundation
Yrjo Jahnsson Foundation

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 22, 2009

First Posted (ESTIMATE)

May 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A18/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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