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

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.

Study Overview

• Status: Completed
• Conditions: Cervicogenic Headache
• Intervention / Treatment: Other: Training protocol with the cervical device for treatment (CDAT).; Other: Conventional training protocol

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50018
    • Élite Fisioterapia, María Montessori 2.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Conventional training protocol; Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.	Other: Conventional training protocol; Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	Change between baseline and post intervention (6 weeks) and after 10 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craniocervical flexion test	The examiners assess the strength of deep cervical flexors with craniocervical flexion test.	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]	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.	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).	6 weeks

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Investigators: Principal Investigator: Pilar Pardos-Aguilella, UicCatalunya

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Actual): October 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: muscle weakness; exercise therapy; telerehabilitation; neck muscles; headache pain
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache
• Other Study ID Numbers: C.P-C.I.PI21/357

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No