Low Back Pain, RecurrentNCT00908102
Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials
A study testing Moderate, Mild and Mild vs. NC in people with Low Back Pain, Recurrent and Low Back Pain, run by University of Helsinki at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 56 years
- Conditions the study is for
- Low Back Pain, Recurrent, Low Back Pain
- What is being tested?
- Moderate, Mild and Mild vs. NC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 505 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2001to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 56 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
- retirement
- acute nerve root compression symptoms
- malignant tumor
- recent fracture
- severe osteoporosis
- other specific disease preventing participation in the follow-up
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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.
- Conditions
- Low Back Pain, Recurrent, Low Back Pain
- Being tested
- Moderate, Mild, Mild vs. NC, Moderate vs. NC
- Keywords
- low back pain, recurrent, subacute, secondary prevention, primary care, occupational health, back book, rehabilitation
- Medical subject headings
- Low Back Pain, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModerateOther
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.
MildOther
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. NCOther
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. NCOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mild; Other: Mild vs. NC |
| 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. Receives: Other: Moderate; Other: Mild; Other: Mild vs. NC; Other: Moderate vs. NC |
| 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. Receives: Other: Moderate; Other: Moderate vs. NC |
| 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. Receives: Other: Moderate; Other: Moderate vs. NC |
| NC | Placebo comparator | Natural course of low back pain Receives: Other: Mild vs. NC; Other: Moderate vs. NC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sickness absence days (Low back (LB) specific, other than LB, total)
Measured: 6, 12, 24, 36, 48 months
Low back pain (VAS)
Measured: 0, 3, 6, 12, 24 months
Disability (Roland Morris 18)
Measured: 0, 3, 6, 12, 24 months
Quality of Life (15-D)
Measured: 0, 3, 6, 12, 24 months
Secondary outcomes (2)
Sickness absence periods
Measured: 6, 12, 24, 36, 48 months
Disability (Oswestry's index)
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startSep 2001
- Primary completionSep 2008
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu, Juho Vainio Foundation, Finnish Cultural Foundation, Yrjo Jahnsson Foundation, Finnish Work Environment Fund
- Responsible party
- Principal investigator, Jarmo Rantonen, University of Helsinki
- Investigators
- Simo Taimela, MD, docent, Study director, Evalua Finland Co.Jaro Karppinen, MD,professor, Study director, University of OuluMarkku Hupli, MD, PhD, Study director, South Karelian Central HospitalJarmo O Rantonen, MD, Principal investigator, University of HelsinkiAntti Malmivaara, MD, PhD, Study director, Finnish Institute for Health and WelfareSatu Luoto, MD, Study director, South Karelian Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908102
- Sponsor's protocol ID
- A18/01
- Status last verified
- Mar 2015
- First submitted
- 19 May 2009
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29739371Rantonen 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.
PubMed 27068751Rantonen 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.
PubMed 24185642Rantonen 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.
PubMed 21602539
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00908102
- Acronym / sponsor ID
- A18/01
- Conditions
- Low Back Pain, Recurrent, Low Back Pain
- Keywords
- low back pain, recurrent, subacute, secondary prevention, primary care, occupational health, back book, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 505 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- University of Oulu, Juho Vainio Foundation, Finnish Cultural Foundation, Yrjo Jahnsson Foundation, Finnish Work Environment Fund
- Study start
- Sep 2001
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BB | Active comparator | Other: Mild, Other: Mild vs. NCSubjects 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 | Other: Moderate, Other: Mild, Other: Mild vs. NC, Other: Moderate vs. NCSubjects 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 | Other: Moderate, Other: Moderate vs. NCA 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 | Other: Moderate, Other: Moderate vs. NCAn 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 | Placebo comparator | Other: Mild vs. NC, Other: Moderate vs. NCNatural course of low back pain |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- retirement
- acute nerve root compression symptoms
- malignant tumor
- recent fracture
- severe osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModerateA 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 | BB+A, DBC, PMU |
| MildA 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 | BB, BB+A |
| Mild vs. NCA 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 | BB, BB+A, NC |
| Moderate vs. NCA 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. | Other | BB+A, DBC, NC, PMU |
Primary outcome
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
2 secondary outcomes
Sickness absence periods
Time frame: 6, 12, 24, 36, 48 months
Disability (Oswestry's index)
Time frame: 3, 6, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Derived from this study: PubMed 29739371Rantonen 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.
- Derived from this study: PubMed 27068751Rantonen 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.
- Derived from this study: PubMed 24185642Rantonen 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.
- Derived from this study: PubMed 21602539Rantonen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simo Taimela, MD, docent study director
Evalua Finland Co.
Jaro Karppinen, MD,professor study director
University of Oulu
Markku Hupli, MD, PhD study director
South Karelian Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate, Mild and Mild vs. NC in people with Low Back Pain, Recurrent and Low Back Pain, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sickness absence days (Low back (LB) specific, other than LB, total) (time frame: 6, 12, 24, 36, 48 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00908102, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.