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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

Tracking Information
First Submitted Date  ICMJE May 19, 2009
First Posted Date  ICMJE May 25, 2009
Last Update Posted Date March 18, 2015
Study Start Date  ICMJE September 2001
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
  • Sickness absence periods [ Time Frame: 6, 12, 24, 36, 48 months ]
  • Disability (Oswestry's index) [ Time Frame: 3, 6, 12, 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Low Back Pain, Recurrent
  • Low Back Pain
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Other: Mild
    • Other: Mild vs. NC
  • 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.

    Interventions:
    • Other: Moderate
    • Other: Mild
    • Other: Mild vs. NC
    • Other: Moderate vs. NC
  • 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.
    Interventions:
    • Other: Moderate
    • Other: Moderate vs. NC
  • 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.
    Interventions:
    • Other: Moderate
    • Other: Moderate vs. NC
  • Placebo Comparator: NC
    Natural course of low back pain
    Interventions:
    • Other: Mild vs. NC
    • Other: Moderate vs. NC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: May 22, 2009)
505
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 56 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00908102
Other Study ID Numbers  ICMJE A18/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jarmo Rantonen, University of Helsinki
Study Sponsor  ICMJE University of Helsinki
Collaborators  ICMJE
  • University of Oulu
  • Juho Vainio Foundation
  • Finnish Cultural Foundation
  • Yrjo Jahnsson Foundation
  • Finnish Work Environment Fund
Investigators  ICMJE
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 National Institute for Health and Welfare, Finland
Study Director: Satu Luoto, MD South Karelian Central Hospital
PRS Account University of Helsinki
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP