Neck PainPhase 2NCT01926262
Exercise as Treatment of Neck Pain Among Helicopter Pilots and Crew Members
A Phase 2 study testing Specific Strength Training in people with Neck Pain and Shoulder Pain, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The aim of this project is to investigate, whether physical training, targeted neck and shoulder muscles, can reduce and prevent neck pain among military helicopter pilots and crewmembers. 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, Shoulder Pain
- What is being tested?
- Specific Strength Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Apr 2014
- Phase
- Phase 2
- 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
- Employed within the Royal Danish Air Force
- Helicopter pilot
- Crewmember (Flight engineer, Rescue swimmer or Mission System Operator)
- Flown within the past 6 months
Who cannot join
- Grounded at time of inclusion
- Participated in a training intervention within the past 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Exercise Against Neck and Shoulder Pain in Danish Military Helicopter Pilots and Crewmembers - A Clinical Randomized, Controlled Trail
The aim of this project is to investigate, whether physical training, targeted neck and shoulder muscles, can reduce and prevent neck pain among military helicopter pilots and crewmembers.
Read the detailed description
Military helicopter pilots and crewmembers is often burdened by work-related neck and shoulder pain. Neck pain is a health challenge, that can reduce functional level, concentration and operational safety. Physical exercise has shown good efficacy in reducing neck/shoulder pain in other occupational groups in previous studies.
The Royal Danish Air Force and the University of Southern Denmark, wishes to examine whether specific physical exercise can prevent and reduce neck/shoulder pain within this occupational group.
Participants in this project will be randomly selected to either a physical exercise group or a reference group.
- The physical exercise group will follow a training program targeted neck and shoulder muscles and train 1 hour per week (3 x 20 min) for 26 weeks.
- The reference group will continue normal routines, including workout routines. They will later be offered the same training program as the Physical Exercise group provided that training has a positive effect.
- Conditions
- Neck Pain, Shoulder Pain
- Being tested
- Specific Strength Training
- Keywords
- Pain, Neck, Exercise, Pilots, Crewmembers,
- Medical subject headings
- Neck Pain, Shoulder Pain, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Strength TrainingBehavioural
Specific Strength Training for the Neck and Shoulder Muscles
| Study group | Role | What they receive |
|---|---|---|
| Physical Exercise Group | Experimental | Specific Strength Training for the Neck and Shoulder muscles Receives: Behavioral: Specific Strength Training |
| Reference group | No intervention | No Specific Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck and shoulder pain
Neck pain will be assessed as self-rated pain on a 10 point scale by questionnaire at baseline and follow-up after 6 months
Measured: 6 months
Secondary outcomes (3)
Pressure-Pain-Threshold
Pressure-Pain-Threshold will be assessed at baseline and follow-up after 6 months
Measured: 6 months
Muscle strength and steadiness
Muscle strength and steadiness will be quantified by force transducers at baseline and follow-up after 6 months
Measured: 6 months
Postural stability
Postural stability will be assessed at baseline and follow-up after 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Danish Air Force
- Responsible party
- Principal investigator, Mike Murray, University of Southern Denmark
- Investigators
- Gisela Sjøgaard, Professor.,, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926262
- Sponsor's protocol ID
- S-20120121
- Status last verified
- Dec 2015
- First submitted
- 16 Aug 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Murray M, Lange B, Nornberg BR, Sogaard K, Sjogaard G. Self-administered physical exercise training as treatment of neck and shoulder pain among military helicopter pilots and crew: a randomized controlled trial. BMC Musculoskelet Disord. 2017 Apr 7;18(1):147. doi: 10.1186/s12891-017-1507-3.
PubMed 28388892Murray M, Lange B, Nornberg BR, Sogaard K, Sjogaard G. Specific exercise training for reducing neck and shoulder pain among military helicopter pilots and crew members: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2015 Aug 19;16:198. doi: 10.1186/s12891-015-0655-6.
PubMed 26286707
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise Against Neck and Shoulder Pain in Danish Military Helicopter Pilots and Crewmembers - A Clinical Randomized, Controlled Trail
- ClinicalTrials.gov ID
- NCT01926262
- Acronym / sponsor ID
- S-20120121
- Conditions
- Neck Pain, Shoulder Pain
- Keywords
- Pain, Neck, Exercise, Pilots, Crewmembers,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- The Royal Danish Air Force
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Aug 2013 (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 aim of this project is to investigate, whether physical training, targeted neck and shoulder muscles, can reduce and prevent neck pain among military helicopter pilots and crewmembers.
Detailed description
Military helicopter pilots and crewmembers is often burdened by work-related neck and shoulder pain. Neck pain is a health challenge, that can reduce functional level, concentration and operational safety. Physical exercise has shown good efficacy in reducing neck/shoulder pain in other occupational groups in previous studies.
The Royal Danish Air Force and the University of Southern Denmark, wishes to examine whether specific physical exercise can prevent and reduce neck/shoulder pain within this occupational group.
Participants in this project will be randomly selected to either a physical exercise group or a reference group.
- The physical exercise group will follow a training program targeted neck and shoulder muscles and train 1 hour per week (3 x 20 min) for 26 weeks.
- The reference group will continue normal routines, including workout routines. They will later be offered the same training program as the Physical Exercise group provided that training has a positive effect.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Exercise Group | Experimental | Behavioral: Specific Strength TrainingSpecific Strength Training for the Neck and Shoulder muscles |
| Reference group | No intervention | –No Specific Strength Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Employed within the Royal Danish Air Force
- Helicopter pilot
- Crewmember (Flight engineer, Rescue swimmer or Mission System Operator)
- Flown within the past 6 months
Key exclusion criteria (2 listed)
- Grounded at time of inclusion
- Participated in a training intervention within the past 12 months
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 |
|---|---|---|
| Specific Strength TrainingSpecific Strength Training for the Neck and Shoulder Muscles | Behavioural | Physical Exercise Group |
Primary outcome
Neck and shoulder pain
Time frame: 6 months
Neck pain will be assessed as self-rated pain on a 10 point scale by questionnaire at baseline and follow-up after 6 months
3 secondary outcomes
Pressure-Pain-Threshold
Time frame: 6 months
Muscle strength and steadiness
Time frame: 6 months
Postural stability
Time frame: 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 2 Dec 2015.
- Derived from this study: PubMed 28388892Murray M, Lange B, Nornberg BR, Sogaard K, Sjogaard G. Self-administered physical exercise training as treatment of neck and shoulder pain among military helicopter pilots and crew: a randomized controlled trial. BMC Musculoskelet Disord. 2017 Apr 7;18(1):147. doi: 10.1186/s12891-017-1507-3.
- Derived from this study: PubMed 26286707Murray M, Lange B, Nornberg BR, Sogaard K, Sjogaard G. Specific exercise training for reducing neck and shoulder pain among military helicopter pilots and crew members: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2015 Aug 19;16:198. doi: 10.1186/s12891-015-0655-6.
- University of Southern DenmarkLink provided by the sponsor.
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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 Sjøgaard, Professor., study director
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Specific Strength Training in people with Neck Pain and Shoulder 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 4 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 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 and shoulder pain (time frame: 6 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 NCT01926262, which also lists 2 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 2 Dec 2015.