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

Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00908102
• Other study ID #: A18/01
• Status: Active, not recruiting
• Phase: N/A
• First received: May 19, 2009
• Last updated: March 17, 2015
• Start date: September 2001
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 505
• Est. completion date: December 2016
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 56 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Recurrent

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Finland	University of Helsinki	Helsinki

Sponsors (6)

Lead Sponsor	Collaborator
Helsinki University	Finnish Cultural Foundation, Finnish Work Environment Fund, Juho Vainio Foundation, University of Oulu, Yrjo Jahnsson Foundation

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sickness absence days (Low back (LB) specific, other than LB, total)		6, 12, 24, 36, 48 months	No
Primary	Low back pain (VAS)		0, 3, 6, 12, 24 months	No
Primary	Disability (Roland Morris 18)		0, 3, 6, 12, 24 months	No
Primary	Quality of Life (15-D)		0, 3, 6, 12, 24 months	No
Secondary	Sickness absence periods		6, 12, 24, 36, 48 months	No
Secondary	Disability (Oswestry's index)		3, 6, 12, 24 months	No