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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00908102
Other study ID # A18/01
Secondary ID
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


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
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