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

Primary Purpose

Low Back Pain, Neck Pain, Muscular Atrophy

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Low back exercises 1
Low back exercise 2
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low back exercises 1

Low back exercise 2

Arm Description

Specific low back extensor exercises in special training bench

Traditional low back exercises.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 5, 2013
Last Updated
March 23, 2020
Sponsor
Helse Stavanger HF
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1. Study Identification

Unique Protocol Identification Number
NCT01788111
Brief Title
Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots.
Official Title
Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Neck Pain, Muscular Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low back exercises 1
Arm Type
Experimental
Arm Description
Specific low back extensor exercises in special training bench
Arm Title
Low back exercise 2
Arm Type
Active Comparator
Arm Description
Traditional low back exercises.
Intervention Type
Other
Intervention Name(s)
Low back exercises 1
Intervention Description
Excentric / concentric extension type exercises
Intervention Type
Other
Intervention Name(s)
Low back exercise 2
Intervention Description
Traditional low back training
Primary Outcome Measure Information:
Title
Multifidus muscle fat infiltration (% of muscle volume).
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Lumbar multifidus muscles contractability.
Description
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.
Time Frame
Two years
Other Pre-specified Outcome Measures:
Title
Number and duration of sick leaves amongst helicopter pilots
Description
Effect on spinal health with sick leave frequency in helicopter pilots. Change from baseline in numbers and duration compared to previous years statistics.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan P Larsen, Prof.Dr.Med
Organizational Affiliation
Research Dep. Stavanger University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Research Dep. Stavanger University Hospital Armauer Hansens vei 20 PB 8100 4068 Stavanger
City
Stavanger
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26564761
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.
Results Reference
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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
Results Reference
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PubMed Identifier
28633669
Citation
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.
Results Reference
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PubMed Identifier
29278872
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.
Results Reference
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Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots.

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