Neck Pain in Danish Military Pilots and Flight Crew | NCT00812903

Studies
Neck Pain in Danish Military Pilots and Flight Crew

NCT00812903

Sponsor

University of Southern Denmark

Status

Completed

Last Update Posted

Dec 3, 2015Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Neck Pain

Interventions

Exercise

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Aug 2011Actual

First Submitted Date

Dec 18, 2008

First Submission Date that Met QC Criteria

Dec 18, 2008

First Posted Date

Dec 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Britt Lange, MD, University of Southern DenmarkPrincipal Investigator

Lead Sponsor

University of Southern DenmarkOTHER

Collaborators

Name	Class
Odense University Hospital	OTHER
Danish Defence	UNKNOWN
Royal Danish Air Force	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the prevalence of neck and shoulder pain in Danish fighter pilots, helicopter pilots and helicopter flight crew and to evaluate the effect of a 24 weeks exercise intervention for fighter pilots.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Control group
Exercise	Experimental	Intervention group	Behavioral: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Behavioral	Training exercises chosen with background in knowledge of intelligent training	Exercise

Measure	Description	Time Frame
Neck pain		1 year
Compliance to training exercises		1 year

Measure	Description	Time Frame
Muscle strength		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Military fighter and helicopter pilots and crew
Active flying 2006 or later

Exclusion Criteria:

Pilots and crew not active since 2005 or earlier
Pilots and crew with other nationality than Danish

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gisela Sjoegaard, Professor	University of Souther Denmark	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fighterwing Skrydstrup		Vojens		6500	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10658420	Background	Jones JA, Hart SF, Baskin DS, Effenhauser R, Johnson SL, Novas MA, Jennings R, Davis J. Human and behavioral factors contributing to spine-based neurological cockpit injuries in pilots of high-performance aircraft: recommendations for management and prevention. Mil Med. 2000 Jan;165(1):6-12.

ID	Term
D019547	Neck Pain
D010146	Pain
D009043	Motor Activity

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001519	Behavior

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena