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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Helsinki University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Oulu
Juho Vainio Foundation
Finnish Cultural Foundation
Yrjo Jahnsson Foundation
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00908102
First received: May 19, 2009
Last updated: November 12, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Low Back Pain, Recurrent
Low Back Pain
 Behavioral: Back book
Behavioral: Back book and Advice
Behavioral: Physical Medicine Unit
Behavioral: Documentation based care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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 RCT's of Various Levels.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Sickness absence days (Low back (LB) specific, other than LB, total) [ Time Frame: 6, 12, 24, 36, 48 months ] [ Designated as safety issue: No ]
  • Low back pain (VAS) [ Time Frame: 0, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Disability (Roland Morris 18) [ Time Frame: 0, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Quality of Life (15-D) [ Time Frame: 0, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sickness absence periods [ Time Frame: 6, 12, 24, 36, 48 months ] [ Designated as safety issue: No ]
  • Disability (Oswestry's index) [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]

Enrollment: 505
Study Start Date: September 2001
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mild low back pain
A two level intervention with long-term 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.
 Behavioral: Back book
Subjects received the back book, which is an self-information booklet about managing low back symptoms.
Other Name: BB
Behavioral: Back book and Advice

Subjects received a back book booklet and also oral advice based on the back book by the occupational health professional.

Intervention was also used as a control at the moderate arm.

Other Name: BBA
Moderate low back pain
A two level active intervention with two control groups was executed for patients suffering from non-acute, moderate LBP in occupational health. Patients were selected by using a self-administered postal questionnaire.
 Behavioral: Back book
Subjects received the back book, which is an self-information booklet about managing low back symptoms.
Other Name: BB
Behavioral: Back book and Advice

Subjects received a back book booklet and also oral advice based on the back book by the occupational health professional.

Intervention was also used as a control at the moderate arm.

Other Name: BBA
Behavioral: Physical Medicine Unit
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.
Other Name: PMU
Behavioral: Documentation based care
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.
Other Name: DBC

Detailed Description:

Eligible subjects were divided into two randomised controlled trials with the name of "mild" or "moderate" low back pain trials.

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

Ages Eligible for Study:   18 Years to 56 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908102

Locations
Finland
University of Helsinki
Helsinki, Finland, 00100
Sponsors and Collaborators
Helsinki University
University of Oulu
Juho Vainio Foundation
Finnish Cultural 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 Helsinki University
Study Director: Antti Malmivaara, MD, PhD National Institute for Health and Welfare, Finland
Study Director: Satu Luoto, MD South Karelian Central Hospital
  More Information

No publications provided by Helsinki University

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

Responsible Party: Jarmo Rantonen, MD, University of Helsinki
ClinicalTrials.gov Identifier: NCT00908102     History of Changes
Other Study ID Numbers: A18/01
Study First Received: May 19, 2009
Last Updated: November 12, 2009
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by Helsinki University:
low back pain
recurrent
subacute
secondary prevention
 primary care
occupational health
back book
rehabilitation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013