Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache.

April 26, 2021 updated by: Jacobo Rodríguez-Sanz, Universidad de Zaragoza

Short- and Mid-Term Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache. A Randomized Controlled Trial.

Cervicogenic headache is defined as unilateral headache associated with neck pain. Effect of manual translatoric therapy of the upper cervical spine associated with cervical exercises in these patients is currently unknown. Our aim was to determine if adding manual therapy to an exercise and home-exercise program improved effects on symptoms and function in short- and mid-term in patients with cervicogenic headache.

A randomized controlled study will be conducted with 40 subjects with cervicogenic headache. Each group will receive four 20-minute sessions weekly and a home-exercise program. Upper cervical flexion, flexion-rotation test, Impact Headache Test-6 (HIT-6), headache intensity, craniocervical flexion test, pain pressure thresholds and Global Rating of Change (GROC)-Scale will be assessed at end of the intervention, at 3- and at 6-month follow-ups.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zaragoza, Spain, 50009
        • Universidad de Zaragoza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)
  • Hypomobility in one or more segments of C0-1, C1-2, C2-3 through manual evaluation.
  • A positive result in the flexion-rotation test.
  • A failure to pass stage 2 (24 mmHg) of the craniocervical flexion test.
  • Be at least 18 years old.
  • Have signed the informed consent.

Exclusion Criteria:

  • Contraindications for manual therapy or exercise.
  • Participation in exercise or manual therapy programs in the last three months.
  • Inability to maintain supine position.
  • The use of pacemakers (the magnets in the CROM device could alter their signal).
  • Inability to perform the flexion-rotation test.
  • Language difficulties.
  • Pending litigation or lawsuits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual Therapy + Exercise Group
Combination of manual therapy and exercises for cervicogenic headache
Combination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache
Active Comparator: Exercise Group
Only exercises for cervicogenic headache
Exercises for cervicogenic headache

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache Intensity (HIT-6)
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Test-6 questionnaire (HIT-6) will be used to describe the degree of pain and disability caused by the headache, with a reliability higher than 0.70. The results are classified into four categories that score daily life impact of headache (little or none, some, substantial and severe.
Change between baseline and post intervention (1 month), after 3 months and after 6 months
Flexion-rotation test
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
This 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 32º
Change between baseline and post intervention (1 month), after 3 months and after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper cervical flexion range of motion
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Active flexion of the upper cervical spine will be measured in standing position using a CROM device
Change between baseline and post intervention (1 month), after 3 months and after 6 months
Headache Intensity
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Headache intensity will be assessed on a visual analogue scale from 0 to 10 cm.
Change between baseline and post intervention (1 month), after 3 months and after 6 months
Craniocervical flexion test
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
This test will be used to measure the strength of the deep flexor muscles. The activation and resistance of the deep flexor muscles will be evaluated in five progressive pressure increases of 2 mmHg up to a maximum of 30 mmHg. The patient will pass to the next level after reaching one certain level three times.
Change between baseline and post intervention (1 month), after 3 months and after 6 months
Pain Pressure Thresholds
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Pain pressure thresholds will be measured using a digital algometer (Somedic AB Farsta, Somedic SenseLab AB, Sweden) with a round surface area of 1 cm2. Pressure will be applied at a rate of 1 kg/cm2/s, perpendicular to the skin. Pressure pain thresholds will be assessed over six points bilaterally with the subject in supine position: suboccipital region, C2-3, C5-6, elevator of scapula, trapezius and first metacarpal joint.
Change between baseline and post intervention (1 month), after 3 months and after 6 months
Global Raiting of Scale (GROC-Scale)
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
GROC-Scale will be used to measure the personal evolution that the patient had experienced. This scale is considered to be an efficient way to score patients' perceived clinical change and test-reliability has shown to be excellent (ICC=0.90).
Change between baseline and post intervention (1 month), after 3 months and after 6 months
Adherence to self-treatment scale
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
This scale will be used in order to measure the adherence to self-treatment at home. Patients will be asked to choose between the following answers: "I have done the exercises every day"; "I have performed the exercises 4-6 days a week"; "I have performed the exercises 1-3 days a week"; "I have performed the exercises less than 1 day a week"; or "I have not performed them".
Change between baseline and post intervention (1 month), after 3 months and after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 26, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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