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OpenTrials
Completed

NCT Number: NCT01788111

Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots.

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.

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Key information

Conditions

Low Back Pain Atrophy Back Pain Muscular Atrophy Neck Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Dep. Stavanger University Hospital Armauer Hansens vei 20 PB 8100 4068 Stavanger

Stavanger, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low back exercises 1

Other

Excentric / concentric extension type exercises

Low back exercise 2

Other

Traditional low back training

Primary outcomes

  1. Multifidus muscle fat infiltration (% of muscle volume).

    Time frame: one year

    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.

Secondary outcomes

  1. Lumbar multifidus muscles contractability.

    Time frame: Two years

    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.

Other outcomes

  1. Number and duration of sick leaves amongst helicopter pilots

    Time frame: Two years

    Effect on spinal health with sick leave frequency in helicopter pilots. Change from baseline in numbers and duration compared to previous years statistics.

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2013
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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