Overview

This trial is active, not recruiting.

Conditions low back pain, recurrent, low back pain
Treatments moderate, mild, mild vs. nc, moderate vs. nc
Sponsor Helsinki University
Collaborator University of Oulu
Start date September 2001
End date September 2008
Trial size 505 participants
Trial identifier NCT00908102, A18/01

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Subjects received the back book booklet, which is an self-information booklet about managing low back symptoms. Included in the Mild and Mild vs. NC interventions.
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.
(Experimental)
Subjects received a back book booklet and also oral advice based on the back book by the occupational health professional (OH Nurse or OH Physician in mild or moderate intervention, respectively). Included in the Mild and Mild vs. NC interventions. Arm was also used as a control at the Moderate and Moderate vs. NC interventions.
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.
(Experimental)
A graded activity back school program was carried out in a physiotherapy out-patient clinic that consisted of one-hour session twice or three times per week, lasting for 12 weeks, supervised by a specially trained physiotherapist. Arm is included in the MOderate and Moderate vs. NC interventions.
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.
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.
(Experimental)
An intensive, multidisciplinary LBP rehabilitation program was carried out in a physical medicine out-patient unit at the local Central Hospital. The program included a 3-week pre-course of 1,5 hour session at 3 days per week, closely followed by a 3-week intensive rehabilitation course of 6.5 hours per day for 5 days per week. A personal graded activity training program was made for each subject and patients were later called for follow-up visit within 1 year of the initial course. Arm is included in the MOderate and Moderate vs. NC interventions.
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.
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.
(Placebo Comparator)
Natural course of low back pain
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.

Primary Outcomes

Measure
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

Measure
Sickness absence periods
time frame: 6, 12, 24, 36, 48 months
Disability (Oswestry's index)
time frame: 3, 6, 12, 24 months

Eligibility Criteria

Male or female participants from 18 years up to 56 years old.

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

Additional Information

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.
Principal investigator Jarmo O Rantonen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Helsinki University.