This trial is active, not recruiting.

Conditions low back pain, neck pain, muscular atrophy
Treatments low back exercises 1, low back exercise 2
Sponsor Helse Stavanger HF
Start date January 2013
End date April 2017
Trial size 325 participants
Trial identifier NCT01788111, 2010/2254/REK vest, SUS-ID 294


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Specific low back extensor exercises in special training bench
low back exercises 1
Excentric / concentric extension type exercises
(Active Comparator)
Traditional low back exercises.
low back exercise 2
Traditional low back training

Primary Outcomes

Multifidus muscle fat infiltration (% of muscle volume).
time frame: one year

Secondary Outcomes

Lumbar multifidus muscles contractability.
time frame: Two years

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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

Additional Information

Official title Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Helse Stavanger HF.