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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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.

Conditions
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Low Back Pain, Recurrent, Low Back Pain

Intervention / Treatment
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* Other: Moderate
* Other: Mild
* Other: Mild vs. NC
* Other: Moderate vs. NC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 56 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BB<br>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. | Other: Mild<br>* 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.<br>Other: Mild vs. NC<br>* 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.<br>|
| Experimental: BB+A<br>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. | Other: Moderate<br>* 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.<br>Other: Mild<br>* 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.<br>Other: Mild vs. NC<br>* 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.<br>Other: Moderate vs. NC<br>* 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.<br>|
| Experimental: DBC<br>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. | Other: Moderate<br>* 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.<br>Other: Moderate vs. NC<br>* 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.<br>|
| Experimental: PMU<br>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. | Other: Moderate<br>* 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.<br>Other: Moderate vs. NC<br>* 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.<br>|
| Placebo Comparator: NC<br>Natural course of low back pain | Other: Mild vs. NC<br>* 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.<br>Other: Moderate vs. NC<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sickness absence days (Low back (LB) specific, other than LB, total) |  | 6, 12, 24, 36, 48 months | 
| Low back pain (VAS) |  | 0, 3, 6, 12, 24 months | 
| Disability (Roland Morris 18) |  | 0, 3, 6, 12, 24 months | 
| Quality of Life (15-D) |  | 0, 3, 6, 12, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sickness absence periods |  | 6, 12, 24, 36, 48 months | 
| Disability (Oswestry's index) |  | 3, 6, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, recurrent, subacute, secondary prevention, primary care, occupational health, back book, rehabilitation