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

NCT05479149 | Completed

• 1 other identifier: C.P-C.I.PI21/357
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicogenic Headache

Keywords

neck muscles; headache pain; muscle weakness; telerehabilitation; exercise therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Craniocervical flexion test

  Baseline and 6 weeks, 10 weeks.

• Cervical Spine Range of Motion (ROM).

  Baseline and 6 weeks, 10 weeks.

• Deep neck flexor endurance Test.

  Baseline and 6 weeks, 10 weeks.

• Physical activity enjoyment Scale (PACES)

  6 weeks

Study Arms (2)

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.

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.

Other: Conventional training protocol

Interventions

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.

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

Conventional training protocol OTHER

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

Conventional training protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Élite Fisioterapia, María Montessori 2.

Zaragoza, 50018, Spain

Location

MeSH Terms

Conditions

Post-Traumatic Headache; Muscle Weakness

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Pilar Pardos-Aguilella

  UicCatalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colaborator Lecturer in Physiotherapy

Model Details: This will be a randomized controlled trial with 2 different groups

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 29, 2022
• Study Start: August 5, 2022
• Primary Completion: October 15, 2022
• Study Completion: November 15, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

ES (1)