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

Not Applicable

• Conditions: Low Back Pain; Low Back Pain, Recurrent

• Registration Number: NCT00908102
• Lead Sponsor: University of Helsinki

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 Timeline

• Study Start: 2001-09
• Primary Completion: 2008-09
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 505

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Disability (Oswestry's index)	3, 6, 12, 24 months
Sickness absence periods	6, 12, 24, 36, 48 months

Trial Locations

Locations (1)

University of Helsinki; 🇫🇮 Helsinki, Finland