Clinical trial NCT01788111: Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots.
Official title: Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Neck Pain
Muscular Atrophy
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2013-02-11
Enrollment: 325
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* contraindications for physical training/activity

Primary outcomes:
measure: Multifidus muscle fat infiltration (% of muscle volume).
timeFrame: one year
Secondary outcomes:
measure: Lumbar multifidus muscles contractability.
timeFrame: Two years
Other outcomes:
measure: Number and duration of sick leaves amongst helicopter pilots
timeFrame: Two years
Locations:
city: Stavanger
country: Norway
facility: Research Dep. Stavanger University Hospital Armauer Hansens vei 20 PB 8100 4068 Stavanger
Study officials:
affiliation: Research Dep. Stavanger University Hospital
name: Jan P Larsen, Prof.Dr.Med
role: STUDY_CHAIR
References:
citation: 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.
citation: Andersen 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
citation: Andersen 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.
citation: Andersen 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.