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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01926262
Other study ID # S-20120121
Secondary ID
Status Completed
Phase Phase 2
First received August 16, 2013
Last updated December 1, 2015
Start date November 2013
Est. completion date April 2014

Study information

Verified date December 2015
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of this project is to investigate, whether physical training, targeted neck and shoulder muscles, can reduce and prevent neck pain among military helicopter pilots and crewmembers.


Description:

Military helicopter pilots and crewmembers is often burdened by work-related neck and shoulder pain. Neck pain is a health challenge, that can reduce functional level, concentration and operational safety. Physical exercise has shown good efficacy in reducing neck/shoulder pain in other occupational groups in previous studies.

The Royal Danish Air Force and the University of Southern Denmark, wishes to examine whether specific physical exercise can prevent and reduce neck/shoulder pain within this occupational group.

Participants in this project will be randomly selected to either a physical exercise group or a reference group.

- The physical exercise group will follow a training program targeted neck and shoulder muscles and train 1 hour per week (3 x 20 min) for 26 weeks.

- The reference group will continue normal routines, including workout routines. They will later be offered the same training program as the Physical Exercise group provided that training has a positive effect.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Employed within the Royal Danish Air Force

- Helicopter pilot

- Crewmember (Flight engineer, Rescue swimmer or Mission System Operator)

- Flown within the past 6 months

Exclusion Criteria:

- Grounded at time of inclusion

- Participated in a training intervention within the past 12 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Specific Strength Training
Specific Strength Training for the Neck and Shoulder Muscles

Locations

Country Name City State
Denmark Hilicopter Wing Karup Karup

Sponsors (2)

Lead Sponsor Collaborator
University of Southern Denmark The Royal Danish Air Force

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck and shoulder pain Neck pain will be assessed as self-rated pain on a 10 point scale by questionnaire at baseline and follow-up after 6 months 6 months No
Secondary Pressure-Pain-Threshold Pressure-Pain-Threshold will be assessed at baseline and follow-up after 6 months 6 months No
Secondary Muscle strength and steadiness Muscle strength and steadiness will be quantified by force transducers at baseline and follow-up after 6 months 6 months No
Secondary Postural stability Postural stability will be assessed at baseline and follow-up after 6 months 6 months No
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Completed NCT02051478 - Thoracic Manipulation and Mobilization for Neck Pain N/A
Completed NCT01938209 - A Comparison of Seated Thoracic Manipulation and Targeted Supine Thoracic Manipulation on Cervical Flexion Motion and Pain N/A
Completed NCT01205542 - Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function N/A

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