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Effectiveness of a Novel Device for Cervical Training in Cervicogenic Headache.

Primary Purpose

Cervicogenic Headache

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Training protocol with the cervical device for treatment (CDAT).
Conventional training protocol
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring neck muscles, headache pain, muscle weakness, telerehabilitation, exercise therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Deep flexor strength deficit in craniocervical flexion test.
  • Deep extensor strength deficit in neck extensor muscle endurance.
  • A positive result in the flexion-rotation test
  • ≥ 50 score in Headache Impact Test (HIT-6).
  • Diagnosis of cervicogenic headache according to Sjaastad et al. Subjects will have to fulfill both parts I and III of the major criteria for diagnosis (pain aggravated by neck movement, sustained position or external pressure, restricted cervical range of motion, and unilateral pain starting in the neck and radiating to the frontotemporal region)

Exclusion Criteria:

  • Have received head/cervical treatment during the last six month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).
  • Have received cervical manual therapy treatment during the last six month
  • A history of head/cervical trauma or surgery during the last year.
  • The use of pacemakers (the magnets in the CROM device could alter their signal
  • Inability to perform the flexion-rotation test.

Sites / Locations

  • Élite Fisioterapia, María Montessori 2.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Training protocol with the cervical device for treatment (CDAT).

Conventional training protocol

Arm Description

Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.

Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.

Outcomes

Primary Outcome Measures

Change in Flexion Rotation Test (FRT)
Mean change from baseline in Flexion-rotation test after 6 weeks and 10 weeks. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Flexion rotation test will be evaluated. Flexion rotation test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32.
Change in Headache Impact Test (HIT-6) (Headache Disfunction)
Mean change from baseline in Headache Impact Test (HIT-6) after 6 weeks and 10 weeks. The examiners assess the impact of headache on patients' lives using the HIT-6. Very severe impact: 60 or more. Major impact: 56-59 score Some impact: 50-55 score Little or no impact: 49 or less.

Secondary Outcome Measures

Craniocervical flexion test
The examiners assess the strength of deep cervical flexors with craniocervical flexion test.
Cervical Spine Range of Motion (ROM).
Mean change from baseline in Cervical Spine Range of Movement (ROM) after 6 weeks and 10 weeks. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Cervical flexion, extension, right/left sidebending, right/left rotation will be evaluated. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Upper cervical flexion, upper cervical extension will be evaluated.[Time Frame: Baseline and 6 weeks, 10 weeks]
Deep neck flexor endurance Test.
Chin Tuck Neck Flexion Test is an assessment technique intended to determine the endurance of the deep cervical flexors.
Physical activity enjoyment Scale (PACES)
The examiners assess participant satisfaction with cervical deep muscle training. This scale measures enjoyment during physical activity through 16 items, which are preceded by the phrase "When I am active…" This instrument measures enjoyment and bipolar enjoyment, through statements such as "I enjoy it", "I'm bored", "It's very exciting", and "I don't like it". The answers will be collected on a Likert scale from 1 (totally disagree) to 5 (totally agree).

Full Information

First Posted
July 25, 2022
Last Updated
January 25, 2023
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05479149
Brief Title
Effectiveness of a Novel Device for Cervical Training in Cervicogenic Headache.
Official Title
Effectiveness of a Novel Device for Cervical Training in Cervicogenic Headache. Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the clinical results in cervical spine range of motion, endurance deep cervical muscles, headache impact and physical activity enjoyment by a training protocol with the new device for cervical treatment (CDAT) versus conventional training protocol (CT) in subjects with cervicogenic headache.
Detailed Description
The cervical spine is the most mobile region of the spine and must be strong enough to support the weight of the skull. Strength deficits of the deep cervical muscles are related to different clinical conditions, such as cervicogenic headache. Cervicogenic headache is a secondary headache defined as a unilateral headache associated with neck pain, related to a decreased cervical range of motion and strength deficits of the deep cervical muscles. Training protocols can help to improve pain, function, posture and cross-sectional area. However, there are no training protocols in subjects with cervicogenic headache including deep neck extensor and flexor muscles. The cervical device treatment (CDAT) allows us to train the cervical flexor and extensor muscle in a simple and comfortable way.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
neck muscles, headache pain, muscle weakness, telerehabilitation, exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a randomized controlled trial with 2 different groups
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Training protocol with the cervical device for treatment (CDAT).
Arm Type
Experimental
Arm Description
Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.
Arm Title
Conventional training protocol
Arm Type
Active Comparator
Arm Description
Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.
Intervention Type
Other
Intervention Name(s)
Training protocol with the cervical device for treatment (CDAT).
Intervention Description
Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.
Intervention Type
Other
Intervention Name(s)
Conventional training protocol
Intervention Description
Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.
Primary Outcome Measure Information:
Title
Change in Flexion Rotation Test (FRT)
Description
Mean change from baseline in Flexion-rotation test after 6 weeks and 10 weeks. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Flexion rotation test will be evaluated. Flexion rotation test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32.
Time Frame
Change between baseline and post intervention (6 weeks) and after 10 weeks.
Title
Change in Headache Impact Test (HIT-6) (Headache Disfunction)
Description
Mean change from baseline in Headache Impact Test (HIT-6) after 6 weeks and 10 weeks. The examiners assess the impact of headache on patients' lives using the HIT-6. Very severe impact: 60 or more. Major impact: 56-59 score Some impact: 50-55 score Little or no impact: 49 or less.
Time Frame
Change between baseline and post intervention (6 weeks) and after 10 weeks.
Secondary Outcome Measure Information:
Title
Craniocervical flexion test
Description
The examiners assess the strength of deep cervical flexors with craniocervical flexion test.
Time Frame
Baseline and 6 weeks, 10 weeks.
Title
Cervical Spine Range of Motion (ROM).
Description
Mean change from baseline in Cervical Spine Range of Movement (ROM) after 6 weeks and 10 weeks. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Cervical flexion, extension, right/left sidebending, right/left rotation will be evaluated. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Upper cervical flexion, upper cervical extension will be evaluated.[Time Frame: Baseline and 6 weeks, 10 weeks]
Time Frame
Baseline and 6 weeks, 10 weeks.
Title
Deep neck flexor endurance Test.
Description
Chin Tuck Neck Flexion Test is an assessment technique intended to determine the endurance of the deep cervical flexors.
Time Frame
Baseline and 6 weeks, 10 weeks.
Title
Physical activity enjoyment Scale (PACES)
Description
The examiners assess participant satisfaction with cervical deep muscle training. This scale measures enjoyment during physical activity through 16 items, which are preceded by the phrase "When I am active…" This instrument measures enjoyment and bipolar enjoyment, through statements such as "I enjoy it", "I'm bored", "It's very exciting", and "I don't like it". The answers will be collected on a Likert scale from 1 (totally disagree) to 5 (totally agree).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Deep flexor strength deficit in craniocervical flexion test. Deep extensor strength deficit in neck extensor muscle endurance. A positive result in the flexion-rotation test ≥ 50 score in Headache Impact Test (HIT-6). Diagnosis of cervicogenic headache according to Sjaastad et al. Subjects will have to fulfill both parts I and III of the major criteria for diagnosis (pain aggravated by neck movement, sustained position or external pressure, restricted cervical range of motion, and unilateral pain starting in the neck and radiating to the frontotemporal region) Exclusion Criteria: Have received head/cervical treatment during the last six month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination). Have received cervical manual therapy treatment during the last six month A history of head/cervical trauma or surgery during the last year. The use of pacemakers (the magnets in the CROM device could alter their signal Inability to perform the flexion-rotation test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Pardos-Aguilella
Organizational Affiliation
UicCatalunya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Élite Fisioterapia, María Montessori 2.
City
Zaragoza
ZIP/Postal Code
50018
Country
Spain

12. IPD Sharing Statement

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Effectiveness of a Novel Device for Cervical Training in Cervicogenic Headache.

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