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.
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 |
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).
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | University of Helsinki | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Helsinki University | Finnish Cultural Foundation, Finnish Work Environment Fund, Juho Vainio Foundation, University of Oulu, Yrjo Jahnsson Foundation |
Finland,
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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