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

University of Helsinki505 enrolled

Overview

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).

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

505

Conditions

Low Back Pain, Recurrent Low Back Pain

Interventions

ModerateOTHER

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.

MildOTHER

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. NCOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 56 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Helsinki

Helsinki, Finland

Outcomes

Primary Outcomes

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

Secondary Outcomes

Sickness absence periods

Time frame: 6, 12, 24, 36, 48 months

Disability (Oswestry's index)

Time frame: 3, 6, 12, 24 months

Data from ClinicalTrials.gov

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