NCT01788111

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 24, 2020

Status Verified

December 1, 2019

Enrollment Period

6.9 years

First QC Date

February 5, 2013

Last Update Submit

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

EXPERIMENTAL

Specific low back extensor exercises in special training bench

Other: Low back exercises 1

Low back exercise 2

ACTIVE COMPARATOR

Traditional low back exercises.

Other: Low back exercise 2

Interventions

Excentric / concentric extension type exercises

Low back exercises 1

Traditional low back training

Low back exercise 2

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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: 26564761BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 28633669BACKGROUND
  • 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.

    PMID: 29278872BACKGROUND

MeSH Terms

Conditions

Low Back PainNeck PainMuscular Atrophy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeuromuscular ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Study Officials

  • Jan P Larsen, Prof.Dr.Med

    Research Dep. Stavanger University Hospital

    STUDY CHAIR

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

Locations