Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials
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ClinicalTrials.gov Identifier: NCT00908102 |
Recruitment Status : Unknown
Verified March 2015 by Jarmo Rantonen, University of Helsinki.
Recruitment status was: Active, not recruiting
First Posted : May 25, 2009
Last Update Posted : March 18, 2015
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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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Low Back Pain, Recurrent Low Back Pain | Other: Moderate Other: Mild Other: Mild vs. NC Other: Moderate vs. NC | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 505 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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. |
Study Start Date : | September 2001 |
Actual Primary Completion Date : | September 2008 |
Estimated Study Completion Date : | December 2016 |
Arm | Intervention/treatment |
---|---|
Active Comparator: BB
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
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. Other: 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: BB+A
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
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. Other: 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. Other: 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. Other: 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: DBC
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.
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Other: 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. Other: 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: PMU
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.
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Other: 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. Other: 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: NC
Natural course of low back pain
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Other: 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. Other: 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. |
- 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 ]
- Sickness absence periods [ Time Frame: 6, 12, 24, 36, 48 months ]
- Disability (Oswestry's index) [ Time Frame: 3, 6, 12, 24 months ]

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Ages Eligible for Study: | 18 Years to 56 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 18-56 years
- present employment at the company
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908102
Finland | |
University of Helsinki | |
Helsinki, Finland, 00100 |
Study Director: | 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 | |
Principal Investigator: | Jarmo O Rantonen, MD | University of Helsinki | |
Study Director: | Antti Malmivaara, MD, PhD | Finnish Institute for Health and Welfare | |
Study Director: | Satu Luoto, MD | South Karelian Central Hospital |
Responsible Party: | Jarmo Rantonen, MD, University of Helsinki |
ClinicalTrials.gov Identifier: | NCT00908102 |
Other Study ID Numbers: |
A18/01 |
First Posted: | May 25, 2009 Key Record Dates |
Last Update Posted: | March 18, 2015 |
Last Verified: | March 2015 |
low back pain recurrent subacute secondary prevention |
primary care occupational health back book rehabilitation |
Back Pain Low Back Pain Pain Neurologic Manifestations |