Back Problems and Other Musculoskeletal InjuriesVASTENCT00595816
Injury Prevention Among Conscripts
A study testing physical training and counselling in people with Back Problems and Other Musculoskeletal Injuries, run by UKK Institute at 2 sites in Finland.
Trial summary
The purpose of this clinical trial is to study the effect of neuromuscular training program and regular safety counselling on the risk of musculoskeletal injuries in adolescent conscripts. 800 voluntary participants are recruited from the four army companies in western Finland during the years 2007 and 2008. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Back Problems and Other Musculoskeletal Injuries
- What is being tested?
- physical training and counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 2 sitesFinland
- Study dates
- Jul 2007to Jan 2008
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy conscripts who gave informed consent for participation
Who cannot join
- disease or injury preventing physical training
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Jari Parkkari
Tampere, P.O Box 30, 33501
Jari Parkkari
Tampere, Pirkanmaa, 33500
About this study
Official title: Prevention of Musculoskeletal Injuries in Finnish Conscripts. A Cluster Randomized Controlled Trial.
The purpose of this clinical trial is to study the effect of neuromuscular training program and regular safety counselling on the risk of musculoskeletal injuries in adolescent conscripts.
800 voluntary participants are recruited from the four army companies in western Finland during the years 2007 and 2008.
- Being tested
- physical training and counselling
- Keywords
- low back pain, physical fitness, injury, prevention, conscripts
- Medical subject headings
- Low Back Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical training and counsellingOther
Neuromuscular training program 3 times per week 30 minutes per session and counselling on back problems and other musculosceletal injuries
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active treatment: physical training and counselling Receives: Other: physical training and counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal injuries
Measured: 12 months
Secondary outcomes (1)
Intensity of low back pain, Physical fitness
Measured: 1,2,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Back Problems and Other Musculoskeletal InjuriesStudies 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
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UKK Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Finland's Slot Machine Association (RAY), Ministry of Education, Scientific Advisory Board for Defence (MATINE)
- Investigators
- Jari P Parkkari, MD, PhD, Principal investigator, The UKK Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595816
- Sponsor's protocol ID
- UKK VASTE
- Acronym
- VASTE
- Status last verified
- Jan 2008
- First submitted
- 4 Jan 2008
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suni J, Rinne M, Natri A, Statistisian MP, Parkkari J, Alaranta H. Control of the lumbar neutral zone decreases low back pain and improves self-evaluated work ability: a 12-month randomized controlled study. Spine (Phila Pa 1976). 2006 Aug 15;31(18):E611-20. doi: 10.1097/01.brs.0000231701.76452.05.
PubMed 16915076Suni JH, Taanila H, Mattila VM, Ohrankammen O, Vuorinen P, Pihlajamaki H, Parkkari J. Neuromuscular exercise and counseling decrease absenteeism due to low back pain in young conscripts: a randomized, population-based primary prevention study. Spine (Phila Pa 1976). 2013 Mar 1;38(5):375-84. doi: 10.1097/BRS.0b013e318270a12d.
PubMed 22941095Parkkari J, Taanila H, Suni J, Mattila VM, Ohrankammen O, Vuorinen P, Kannus P, Pihlajamaki H. Neuromuscular training with injury prevention counselling to decrease the risk of acute musculoskeletal injury in young men during military service: a population-based, randomised study. BMC Med. 2011 Apr 11;9:35. doi: 10.1186/1741-7015-9-35.
PubMed 21481230
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Musculoskeletal Injuries in Finnish Conscripts. A Cluster Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00595816
- Acronym / sponsor ID
- VASTE / UKK VASTE
- Keywords
- low back pain, physical fitness, injury, prevention, conscripts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- UKK InstituteUniversity, hospital or other
- Collaborators
- Finland's Slot Machine Association (RAY), Ministry of Education, Scientific Advisory Board for Defence (MATINE)
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Jan 2008 (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 clinical trial is to study the effect of neuromuscular training program and regular safety counselling on the risk of musculoskeletal injuries in adolescent conscripts.
800 voluntary participants are recruited from the four army companies in western Finland during the years 2007 and 2008.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: physical training and counsellingActive treatment: physical training and counselling |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy conscripts who gave informed consent for participation
Key exclusion criteria (1 listed)
- disease or injury preventing physical training
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 |
|---|---|---|
| physical training and counsellingNeuromuscular training program 3 times per week 30 minutes per session and counselling on back problems and other musculosceletal injuries | Other | 1 |
Primary outcome
Musculoskeletal injuries
Time frame: 12 months
1 secondary outcome
Intensity of low back pain, Physical fitness
Time frame: 1,2,6 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 16 Jan 2008.
- Background: PubMed 16915076Suni J, Rinne M, Natri A, Statistisian MP, Parkkari J, Alaranta H. Control of the lumbar neutral zone decreases low back pain and improves self-evaluated work ability: a 12-month randomized controlled study. Spine (Phila Pa 1976). 2006 Aug 15;31(18):E611-20. doi: 10.1097/01.brs.0000231701.76452.05.
- Derived from this study: PubMed 22941095Suni JH, Taanila H, Mattila VM, Ohrankammen O, Vuorinen P, Pihlajamaki H, Parkkari J. Neuromuscular exercise and counseling decrease absenteeism due to low back pain in young conscripts: a randomized, population-based primary prevention study. Spine (Phila Pa 1976). 2013 Mar 1;38(5):375-84. doi: 10.1097/BRS.0b013e318270a12d.
- Derived from this study: PubMed 21481230Parkkari J, Taanila H, Suni J, Mattila VM, Ohrankammen O, Vuorinen P, Kannus P, Pihlajamaki H. Neuromuscular training with injury prevention counselling to decrease the risk of acute musculoskeletal injury in young men during military service: a population-based, randomised study. BMC Med. 2011 Apr 11;9:35. doi: 10.1186/1741-7015-9-35.
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.
Jari P Parkkari, MD, PhD principal investigator
The UKK Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical training and counselling in people with Back Problems and Other Musculoskeletal Injuries, run by UKK Institute at 2 sites 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 16 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Musculoskeletal injuries (time frame: 12 months). 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 NCT00595816, which also lists 3 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 16 Jan 2008.