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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Oulu
Juho Vainio Foundation
Finnish Cultural Foundation
Yrjö Jahnsson Foundation
The Finnish Work Environment Fund
Information provided by (Responsible Party):
Jarmo Rantonen, Helsinki University
ClinicalTrials.gov Identifier:
NCT00908102
First received: May 19, 2009
Last updated: March 17, 2015
Last verified: March 2015
  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
Low Back Pain, Recurrent
Low Back Pain
Other: Moderate
Other: Mild
Other: Mild vs. NC
Other: Moderate vs. NC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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 Randomised Controlled Trials (RCT) of Various Levels.

Resource links provided by NLM:


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: December 2016
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Yrjö Jahnsson Foundation
The Finnish Work Environment Fund
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, Helsinki University
ClinicalTrials.gov Identifier: NCT00908102     History of Changes
Other Study ID Numbers: A18/01
Study First Received: May 19, 2009
Last Updated: March 17, 2015
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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 07, 2015