Cervicogenic HeadacheNCT05479149
Effectiveness of a Novel Device for Cervical Training in Cervicogenic Headache.
A study testing Training protocol with the cervical device for treatment (CDAT). and Conventional training protocol in people with Cervicogenic Headache, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Training protocol with the cervical device for treatment (CDAT). and Conventional training protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 5 Aug 2022to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Novel Device for Cervical Training in Cervicogenic Headache. Randomized Clinical Trial.
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.
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- Training protocol with the cervical device for treatment (CDAT)., Conventional training protocol
- Keywords
- neck muscles, headache pain, muscle weakness, telerehabilitation, exercise therapy
- Medical subject headings
- Post-Traumatic Headache, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training protocol with the cervical device for treatment (CDAT).Other
Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.
Conventional training protocolOther
Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Training protocol with the cervical device for treatment (CDAT). | Experimental | Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment. Receives: Other: Training protocol with the cervical device for treatment (CDAT). |
| Conventional training protocol | Active comparator | Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol. Receives: Other: Conventional training protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline and post intervention (6 weeks) and after 10 weeks.
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.
Measured: Change between baseline and post intervention (6 weeks) and after 10 weeks.
Secondary outcomes (4)
Craniocervical flexion test
The examiners assess the strength of deep cervical flexors with craniocervical flexion test.
Measured: Baseline and 6 weeks, 10 weeks.
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]
Measured: 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.
Measured: Baseline and 6 weeks, 10 weeks.
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start5 Aug 2022
- Primary completion15 Oct 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized controlled trial with 2 different groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pilar Pardos Aguilella, Universitat Internacional de Catalunya
- Investigators
- Pilar Pardos-Aguilella, Principal investigator, UicCatalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479149
- Sponsor's protocol ID
- C.P-C.I.PI21/357
- Status last verified
- Jan 2023
- First submitted
- 25 Jul 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel Device for Cervical Training in Cervicogenic Headache. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05479149
- Acronym / sponsor ID
- C.P-C.I.PI21/357
- Conditions
- Cervicogenic Headache
- Keywords
- neck muscles, headache pain, muscle weakness, telerehabilitation, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a randomized controlled trial with 2 different groups
| Arm | Type | Receives |
|---|---|---|
| Experimental: Training protocol with the cervical device for treatment (CDAT). | Experimental | Other: Training protocol with the cervical device for treatment (CDAT).Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment. |
| Conventional training protocol | Active comparator | Other: Conventional training protocolEndurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training protocol with the cervical device for treatment (CDAT).Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment. | Other | Experimental: Training protocol with the cervical device for treatment (CDAT). |
| Conventional training protocolEndurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol. | Other | Conventional training protocol |
Primary outcome
Change in Flexion Rotation Test (FRT)
Time frame: Change between baseline and post intervention (6 weeks) and after 10 weeks.
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)
Time frame: Change between baseline and post intervention (6 weeks) and after 10 weeks.
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.
4 secondary outcomes
Craniocervical flexion test
Time frame: Baseline and 6 weeks, 10 weeks.
Cervical Spine Range of Motion (ROM).
Time frame: Baseline and 6 weeks, 10 weeks.
Deep neck flexor endurance Test.
Time frame: Baseline and 6 weeks, 10 weeks.
Physical activity enjoyment Scale (PACES)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Pardos-Aguilella principal investigator
UicCatalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training protocol with the cervical device for treatment (CDAT). and Conventional training protocol in people with Cervicogenic Headache, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Flexion Rotation Test (FRT) (time frame: Change between baseline and post intervention (6 weeks) and after 10 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.