Clinical trial NCT05479149: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cervicogenic Headache
Keywords: neck muscles
headache pain
muscle weakness
telerehabilitation
exercise therapy
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized controlled trial with 2 different groups
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Flexion Rotation Test (FRT)
timeFrame: Change between baseline and post intervention (6 weeks) and after 10 weeks.
measure: Change in Headache Impact Test (HIT-6) (Headache Disfunction)
timeFrame: Change between baseline and post intervention (6 weeks) and after 10 weeks.
Secondary outcomes:
measure: Craniocervical flexion test
timeFrame: Baseline and 6 weeks, 10 weeks.
measure: Cervical Spine Range of Motion (ROM).
timeFrame: Baseline and 6 weeks, 10 weeks.
measure: Deep neck flexor endurance Test.
timeFrame: Baseline and 6 weeks, 10 weeks.
measure: Physical activity enjoyment Scale (PACES)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Élite Fisioterapia, María Montessori 2.
Study officials:
affiliation: UicCatalunya
name: Pilar Pardos-Aguilella
role: PRINCIPAL_INVESTIGATOR
References: