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

U

Universitat Internacional de Catalunya

Status

Completed

Conditions

Cervicogenic Headache

Treatments

Other: Training protocol with the cervical device for treatment (CDAT).
Other: Conventional training protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT05479149
C.P-C.I.PI21/357

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

28 participants in 2 patient groups

Experimental: Training protocol with the cervical device for treatment (CDAT).
Experimental group
Description:
Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.
Treatment:
Other: Training protocol with the cervical device for treatment (CDAT).
Conventional training protocol
Active Comparator group
Description:
Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.
Treatment:
Other: Conventional training protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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