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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01788111
Other study ID # SUS-ID 294
Secondary ID 2010/2254/REK ve
Status Completed
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date December 2019

Study information

Verified date December 2019
Source Helse Stavanger HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 325
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Low back exercises 1
Excentric / concentric extension type exercises
Low back exercise 2
Traditional low back training

Locations

Country Name City State
Norway Research Dep. Stavanger University Hospital Armauer Hansens vei 20 PB 8100 4068 Stavanger Stavanger

Sponsors (1)

Lead Sponsor Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

References & Publications (4)

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. — View 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. — View 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. — View 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

Outcome

Type Measure Description Time frame Safety issue
Other Number and duration of sick leaves amongst helicopter pilots Effect on spinal health with sick leave frequency in helicopter pilots. Change from baseline in numbers and duration compared to previous years statistics. Two years
Primary 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 Lumbar multifidus muscles contractability. Volume and ability of the lumbar multifidus muscles to contract as shown with ultrasound (% of expansion during reflex activation)Change from baseline at 3,6,9,12 and 24 months. Two years
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