Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots.
2 other identifiers
interventional
325
1 country
1
Brief Summary
The purpose of this project is to investigate the occurrence of neck and back pain in a population of commercial helicopter pilots, and investigate factors related to the profession that can cause these problems. The project has a biological approach assessing the supporting and stabilizing muscles (multifidus) in pilots with chronic back and neck ailments. Pilots with low back problems are invited to a controlled intervention trial to investigate whether one can achieve improved spinal health with a rigid training régime. Primary trial outcome is improved neck and back multifidus muscles pathology and function as assessed by the extent of fat infiltration -as visualized on MRI - and the volume and ability of the lumbar multifidus muscles to contract as shown with ultrasound. The perceived effect on spinal health with sick leave frequency is also evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Jan 2013
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
February 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 24, 2020
December 1, 2019
6.9 years
February 5, 2013
March 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Multifidus muscle fat infiltration (% of muscle volume).
Primary trial outcome is improved neck and back multifidus muscles pathology and function as assessed by the extent of fat infiltration as visualized on MRI (% of muscle volume).Change from baseline at 12 months.
one year
Secondary Outcomes (1)
Lumbar multifidus muscles contractability.
Two years
Other Outcomes (1)
Number and duration of sick leaves amongst helicopter pilots
Two years
Study Arms (2)
Low back exercises 1
EXPERIMENTALSpecific low back extensor exercises in special training bench
Low back exercise 2
ACTIVE COMPARATORTraditional low back exercises.
Interventions
Eligibility Criteria
You may qualify if:
- Pilots must experience low back pain in at least 1 of 3 flights or
- Pilots must have at least 2 episodes of low back pain of at least 24 hours duration over the last 12 months. Each episode is separated with at least one painfree month before and after each episode, or
- Pilots may have had more than 3 sick leaves due to low back pain over the last 5 years
You may not qualify if:
- contraindications for physical training/activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Dep. Stavanger University Hospital Armauer Hansens vei 20 PB 8100 4068 Stavanger
Stavanger, Norway
Related Publications (4)
Andersen K, Baardsen R, Dalen I, Larsen JP. Recurrent and Transient Spinal Pain Among Commercial Helicopter Pilots. Aerosp Med Hum Perform. 2015 Nov;86(11):962-9. doi: 10.3357/AMHP.4237.2015.
PMID: 26564761BACKGROUNDAndersen K, Baardsen R, Haga H, Due G, Dalen I, et al. (2017) Transient Low Back Pain among Helicopter Pilots; Imaging and Lumbar Trunk Muscular Endurance. J Phys Med Rehabil Disabil 3: 021
BACKGROUNDAndersen K, Baardsen R, Dalen I, Larsen JP. Impact of exercise programs among helicopter pilots with transient LBP. BMC Musculoskelet Disord. 2017 Jun 20;18(1):269. doi: 10.1186/s12891-017-1631-0.
PMID: 28633669BACKGROUNDAndersen K, Baardsen R, Dalen I, Larsen JP. Long-term effects of exercise programs among helicopter pilots with flying related LBP. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):1-13. doi: 10.3233/BMR-170897.
PMID: 29278872BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jan P Larsen, Prof.Dr.Med
Research Dep. Stavanger University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2013
First Posted
February 11, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
March 24, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share