Back PainNCT03481426
The Effect of Workplace Interventions on the Treatment of Low-back Pain
A study testing Workplace intervention in people with Back Pain, run by Finnish Institute of Occupational Health at 1 site in Finland.
Trial summary
The study evaluates the effect of workplace interventions on work ability promotion among workers with back problems. The half of participant will receive Information, advice and guidance for back problems in addition to participatory workplace actions organized by Occupational Health Physiotherapist. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Workplace intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2017to 30 Aug 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Back pain for at least two weeks or frequently occuring periods within the past 12 months
Who cannot join
- Back problems with forcoming surcical operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Workplace Interventions Supporting Employees to Continue at Work: Participatory Actions Organized by OH Physiotherapist
The study evaluates the effect of workplace interventions on work ability promotion among workers with back problems. The half of participant will receive Information, advice and guidance for back problems in addition to participatory workplace actions organized by Occupational Health Physiotherapist. The other half will receive only Information, advice and guidance without workplace intervention.
Read the detailed description
Musculoskeletal symptoms, especially back pain, account for the majority of days lost.
In order to enhance the health and working careers of people with MSD, it is important that work can be arranged in such a way that they can remain in work life despite MSD.In the field of work ability promotion, various stakeholders; the worker, employer, professionals in occupational health services (OHS) interact to optimize actions and practices to prevent absences from work and promote remaining at work. This study aims to investigate participatory working practices and modles of co-operation among OHS and workplaces.
- Conditions
- Back Pain
- Being tested
- Workplace intervention
- Keywords
- musculoskelelal disorder, occupational health service
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workplace interventionOther
The study contains normal services of occupational health. Both intervention groups are based on voluntary will, and the normal care and services are guaranteed. In the intervention group new working method which improve co-operation between occupational health services and workplaces.
| Study group | Role | What they receive |
|---|---|---|
| Workplace intervention group | Experimental | Workers with back problems receive both information/advice and participatory workplace intervention organized by Occupational Health Physioterapist. Receives: Other: Workplace intervention |
| Information and advice group | No intervention | Workers with back problems receive only information / advice by Occupational Health Physiotherapist, not the workplace intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
work ability
The present self estimated work ability versus the life time best (0-10)
Measured: through study completion, up to 12 months
Secondary outcomes (1)
intensity of pack pain
The present self estimated back pain, no pain - the worst pain
Measured: through study completion, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Feb 2017
- Primary completion30 Apr 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute of Occupational Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erja Sormunen, PhD, Principal investigator, Finnish Institute of Occupational Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481426
- Sponsor's protocol ID
- ESormunen
- Status last verified
- Apr 2021
- First submitted
- 6 Nov 2017
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the collected data and study results are analyzed anonymous and are kept under the control of the Project group. All the personal data and information of the participants are kept under the control of the Project researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workplace Interventions Supporting Employees to Continue at Work: Participatory Actions Organized by OH Physiotherapist
- ClinicalTrials.gov ID
- NCT03481426
- Acronym / sponsor ID
- ESormunen
- Conditions
- Back Pain
- Keywords
- musculoskelelal disorder, occupational health service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Finnish Institute of Occupational HealthUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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 study evaluates the effect of workplace interventions on work ability promotion among workers with back problems. The half of participant will receive Information, advice and guidance for back problems in addition to participatory workplace actions organized by Occupational Health Physiotherapist. The other half will receive only Information, advice and guidance without workplace intervention.
Detailed description
Musculoskeletal symptoms, especially back pain, account for the majority of days lost.
In order to enhance the health and working careers of people with MSD, it is important that work can be arranged in such a way that they can remain in work life despite MSD.In the field of work ability promotion, various stakeholders; the worker, employer, professionals in occupational health services (OHS) interact to optimize actions and practices to prevent absences from work and promote remaining at work. This study aims to investigate participatory working practices and modles of co-operation among OHS and workplaces.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workplace intervention group | Experimental | Other: Workplace interventionWorkers with back problems receive both information/advice and participatory workplace intervention organized by Occupational Health Physioterapist. |
| Information and advice group | No intervention | –Workers with back problems receive only information / advice by Occupational Health Physiotherapist, not the workplace intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Back pain for at least two weeks or frequently occuring periods within the past 12 months
Key exclusion criteria (1 listed)
- Back problems with forcoming surcical operation
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 |
|---|---|---|
| Workplace interventionThe study contains normal services of occupational health. Both intervention groups are based on voluntary will, and the normal care and services are guaranteed. In the intervention group new working method which improve co-operation between occupational health services and workplaces. | Other | Workplace intervention group |
Primary outcome
work ability
Time frame: through study completion, up to 12 months
The present self estimated work ability versus the life time best (0-10)
1 secondary outcome
intensity of pack pain
Time frame: through study completion, up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No. All the collected data and study results are analyzed anonymous and are kept under the control of the Project group. All the personal data and information of the participants are kept under the control of the Project researchers.
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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.
Erja Sormunen, PhD principal investigator
Finnish Institute of Occupational Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workplace intervention in people with Back Pain, run by Finnish Institute of Occupational Health 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Apr 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
work ability (time frame: through study completion, up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2021.