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The Effects of a Specific Exercise Program on Subjects With Cervicogenic Headache

Primary Purpose

Cervicogenic Headache

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Head extension and rotation movement
Sponsored by
Florida Gulf Coast University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring Cervicogenic headache, MSK Ultrasound, Obliquus capitis minor, Rectus capitis major, Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • No history of surgery, No current neck pain, Being able to move the neck actively, being able to read English, between ages 18-65

Exclusion Criteria:

  • Neck pain, History of surgery, unable to move the head into extension, outside age requirements, unable to read English

Sites / Locations

  • Florida Gulf Coast UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

neck extension group

Arm Description

Neck extension group

Outcomes

Primary Outcome Measures

MSK US image
Assessment of change in width and length of target muscles

Secondary Outcome Measures

Full Information

First Posted
August 10, 2022
Last Updated
September 21, 2023
Sponsor
Florida Gulf Coast University
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1. Study Identification

Unique Protocol Identification Number
NCT05500378
Brief Title
The Effects of a Specific Exercise Program on Subjects With Cervicogenic Headache
Official Title
The Effects of a Specific Exercise Program on Subjects With Cervicogenic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida Gulf Coast University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study explores with the use of MSK Ultrasound imaging if the obliquus capitis minor and the rectus capitis major can be contracted with specific exercises.
Detailed Description
This study explores if a subject with the neck in full maximal flexion is able to selective contract the the obliquus capitis minor and the rectus capitis major by head extension and rotation while maintaining the spine position. MSK Ultrasound imaging will be used to measure changes both in length and width.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Cervicogenic headache, MSK Ultrasound, Obliquus capitis minor, Rectus capitis major, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group design
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neck extension group
Arm Type
Other
Arm Description
Neck extension group
Intervention Type
Other
Intervention Name(s)
Head extension and rotation movement
Intervention Description
Active exercise of the head
Primary Outcome Measure Information:
Title
MSK US image
Description
Assessment of change in width and length of target muscles
Time Frame
The change in muscle length and diameter will be measured during head movement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No history of surgery, No current neck pain, Being able to move the neck actively, being able to read English, between ages 18-65 Exclusion Criteria: Neck pain, History of surgery, unable to move the head into extension, outside age requirements, unable to read English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rob Sillevis, PhD
Phone
2397454312
Email
rsillevis@fgcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob Sillevis, phD
Organizational Affiliation
Florida Gulf Coast University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Gulf Coast University
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33965
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rob Sillevis, PhD
Phone
239-745-4312
Email
rsilllevis@fgcu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of a Specific Exercise Program on Subjects With Cervicogenic Headache

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