Neck PainNCT00812903
Neck Pain in Danish Military Pilots and Flight Crew
A study testing Exercise in people with Neck Pain, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the prevalence of neck and shoulder pain in Danish fighter pilots, helicopter pilots and helicopter flight crew and to evaluate the effect of a 24 weeks exercise intervention for fighter pilots. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2009to Aug 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Military fighter and helicopter pilots and crew
- Active flying 2006 or later
Who cannot join
- Pilots and crew not active since 2005 or earlier
- Pilots and crew with other nationality than Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neck Pain in Danish Military Pilots and Flight Crew - Environmental Factors With Influence on Performance (PH.D.-Project)
The purpose of this study is to determine the prevalence of neck and shoulder pain in Danish fighter pilots, helicopter pilots and helicopter flight crew and to evaluate the effect of a 24 weeks exercise intervention for fighter pilots.
- Conditions
- Neck Pain
- Being tested
- Exercise
- Keywords
- Neck, Pain, Exercise, Pilots, Crew
- Medical subject headings
- Neck Pain, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Training
Training exercises chosen with background in knowledge of intelligent training
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group |
| Exercise | Experimental | Intervention group Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain
Measured: 1 year
Compliance to training exercises
Measured: 1 year
Secondary outcomes (1)
Muscle strength
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startMar 2009
- Primary completionJul 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Danish Defence, Royal Danish Air Force
- Responsible party
- Principal investigator, Britt Lange, University of Southern Denmark
- Investigators
- Gisela Sjoegaard, Professor, Study director, University of Souther Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812903
- Sponsor's protocol ID
- S-20090005
- Status last verified
- Dec 2015
- First submitted
- 18 Dec 2008
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones JA, Hart SF, Baskin DS, Effenhauser R, Johnson SL, Novas MA, Jennings R, Davis J. Human and behavioral factors contributing to spine-based neurological cockpit injuries in pilots of high-performance aircraft: recommendations for management and prevention. Mil Med. 2000 Jan;165(1):6-12.
PubMed 10658420
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Pain in Danish Military Pilots and Flight Crew - Environmental Factors With Influence on Performance (PH.D.-Project)
- ClinicalTrials.gov ID
- NCT00812903
- Acronym / sponsor ID
- S-20090005
- Conditions
- Neck Pain
- Keywords
- Neck, Pain, Exercise, Pilots, Crew
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Danish Defence, Royal Danish Air Force
- Study start
- Mar 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Dec 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 study is to determine the prevalence of neck and shoulder pain in Danish fighter pilots, helicopter pilots and helicopter flight crew and to evaluate the effect of a 24 weeks exercise intervention for fighter pilots.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group |
| Exercise | Experimental | Behavioral: ExerciseIntervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Military fighter and helicopter pilots and crew
- Active flying 2006 or later
Key exclusion criteria (2 listed)
- Pilots and crew not active since 2005 or earlier
- Pilots and crew with other nationality than Danish
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 |
|---|---|---|
| ExerciseAlso: TrainingTraining exercises chosen with background in knowledge of intelligent training | Behavioural | Exercise |
Primary outcome
Neck pain
Time frame: 1 year
Compliance to training exercises
Time frame: 1 year
1 secondary outcome
Muscle strength
Time frame: 1 year
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 3 Dec 2015.
- Background: PubMed 10658420Jones JA, Hart SF, Baskin DS, Effenhauser R, Johnson SL, Novas MA, Jennings R, Davis J. Human and behavioral factors contributing to spine-based neurological cockpit injuries in pilots of high-performance aircraft: recommendations for management and prevention. Mil Med. 2000 Jan;165(1):6-12.
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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.
Gisela Sjoegaard, Professor study director
University of Souther Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Neck Pain, run by University of Southern Denmark at 1 site in Denmark.
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 2 inclusion and 2 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 3 Dec 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 Denmark. 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?
Neck pain (time frame: 1 year). The study lists 2 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 NCT00812903, which also lists 1 linked publication.
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 3 Dec 2015.