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| Name | Class |
|---|---|
| University of Oulu | OTHER |
| Juho Vainio Foundation | OTHER |
| Finnish Cultural Foundation | OTHER |
| Yrjo Jahnsson Foundation |
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The purpose of this study is:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BB | 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. |
|
| BB+A | 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. |
|
| DBC | 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. |
|
| PMU | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate | Other | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sickness absence periods | 6, 12, 24, 36, 48 months | |
| Disability (Oswestry's index) | 3, 6, 12, 24 months |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Simo Taimela, MD, docent | Evalua Finland Co. | Study Director |
| Jaro Karppinen, MD,professor | University of Oulu | Study Director |
| Markku Hupli, MD, PhD | South Karelian Central Hospital | Study Director |
| Jarmo O Rantonen, MD | University of Helsinki | Principal Investigator |
| Antti Malmivaara, MD, PhD | Finnish Institute for Health and Welfare | Study Director |
| Satu Luoto, MD | South Karelian Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Helsinki | Helsinki | 00100 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29739371 | Derived | Rantonen J, Karppinen J, Vehtari A, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Effectiveness of three interventions for secondary prevention of low back pain in the occupational health setting - a randomised controlled trial with a natural course control. BMC Public Health. 2018 May 8;18(1):598. doi: 10.1186/s12889-018-5476-8. | |
| 27068751 |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| OTHER |
| Finnish Work Environment Fund | OTHER |
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|
| NC | Placebo Comparator | Natural course of low back pain |
|
| Mild | Other | 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 | Other | 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 | Other | 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. |
|
| Rantonen J, Karppinen J, Vehtari A, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Cost-effectiveness of providing patients with information on managing mild low-back symptoms in an occupational health setting. BMC Public Health. 2016 Apr 12;16:316. doi: 10.1186/s12889-016-2974-4. |
| 24185642 | Derived | Rantonen J, Vehtari A, Karppinen J, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Face-to-face information combined with a booklet versus a booklet alone for treatment of mild low-back pain: a randomized controlled trial. Scand J Work Environ Health. 2014 Mar;40(2):156-66. doi: 10.5271/sjweh.3398. Epub 2013 Nov 1. |
| 21602539 | Derived | Rantonen J, Luoto S, Vehtari A, Hupli M, Karppinen J, Malmivaara A, Taimela S. The effectiveness of two active interventions compared to self-care advice in employees with non-acute low back symptoms: a randomised, controlled trial with a 4-year follow-up in the occupational health setting. Occup Environ Med. 2012 Jan;69(1):12-20. doi: 10.1136/oem.2009.054312. Epub 2011 May 20. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |