Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials
- Conditions
- Low Back PainLow Back Pain, Recurrent
- Interventions
- Other: ModerateOther: MildOther: Mild vs. NCOther: Moderate vs. NC
- Registration Number
- NCT00908102
- Lead Sponsor
- University of Helsinki
- Brief 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).
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 505
-
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.
- retirement
- acute nerve root compression symptoms
- malignant tumor
- recent fracture
- severe osteoporosis
- other specific disease preventing participation in the follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BB Mild vs. NC 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. BB+A Moderate vs. NC 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. DBC Moderate 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. BB Mild 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. BB+A Moderate 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. BB+A Mild 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. BB+A Mild vs. NC 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. PMU Moderate 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. DBC Moderate vs. NC 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. PMU Moderate vs. NC 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. NC Mild vs. NC Natural course of low back pain NC Moderate vs. NC Natural course of low back pain
- Primary Outcome Measures
Name Time Method Low back pain (VAS) 0, 3, 6, 12, 24 months Disability (Roland Morris 18) 0, 3, 6, 12, 24 months Sickness absence days (Low back (LB) specific, other than LB, total) 6, 12, 24, 36, 48 months Quality of Life (15-D) 0, 3, 6, 12, 24 months
- Secondary Outcome Measures
Name Time Method Disability (Oswestry's index) 3, 6, 12, 24 months Sickness absence periods 6, 12, 24, 36, 48 months
Trial Locations
- Locations (1)
University of Helsinki
🇫🇮Helsinki, Finland