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

NCT ID: NCT05479149

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2022-11-15

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.

Conditions

Cervicogenic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental: 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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Conventional training protocol

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

Group Type: ACTIVE_COMPARATOR

Conventional training protocol

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Conventional training protocol

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Pilar Pardos Aguilella

Colaborator Lecturer in Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pilar Pardos-Aguilella

Role: PRINCIPAL_INVESTIGATOR

UicCatalunya

Locations

Élite Fisioterapia, María Montessori 2.

Zaragoza, , Spain

Countries

Spain

Other Identifiers

C.P-C.I.PI21/357

Identifier Type: -

Identifier Source: org_study_id