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

March 23, 2020 updated by: Helse Stavanger HF
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

325

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low back exercises 1
Specific low back extensor exercises in special training bench
Excentric / concentric extension type exercises
Active Comparator: Low back exercise 2
Traditional low back exercises.
Traditional low back training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jan P Larsen, Prof.Dr.Med, Research Dep. Stavanger University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (Estimate)

February 11, 2013

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SUS-ID 294
  • 2010/2254/REK vest (Other Identifier: REK / Norway)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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