Clinical Effects of Upper Cervical Translatoric Mobilization in Patients With Headache

February 25, 2016 updated by: Miguel Malo Urriés, Universidad de Zaragoza

Frequently, headache is associated with disorders of the cervical spine, specially on the upper cervical spine. Therefore, restoration of the upper cervical mobility is considered fundamental for the treatment of headache.

Manual therapy interventions seek to restore upper cervical mobility through a wide range of therapeutic procedures, including mobilization or manipulation techniques. Previous systematic reviews reported preliminary evidence for the application of upper cervical manual therapy techniques for the management of headache.

The objective of this study is to study the effects of upper cervical translatoric spinal mobilization (UC-TSM) on headache intensity, cervical mobility and pressure pain threshold in subjects with headache. For this purpose, the investigators will conduct a randomized controlled trial. Volunteers with headache will participate in the study and will be randomly divided into control or treatment group. Treatment group will receive UC-TSM and the control group will receive no treatment.

Headache intensity, cervical mobility, temporomandibular mobility and pressure pain thresholds (PPT) will be measured before and immediately after each treatment session (3 treatment sessions in one week period) and after one month follow-up. At this moment, global perceived effect will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

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

  • Spain
    • Aragón
      • Zaragoza, Aragón, Spain, 50009
        • Unidad de Investigación en Fisioterapia

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Present a history of headache.

Exclusion Criteria:

  • Receive cervical treatment in the previous month.
  • Present red flags for headache.
  • Present any contraindications to manual therapy.
  • Current involvement in compensations.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UC-TSM
Upper cervical translatoric spinal mobilization (UC-TSM). UC-TSM is a physical therapy technique used to improve range of movement, consisting on a manual stretching of the cervical spine of the patient during 30 minutes.
Other: UC-TSM
Upper cervical translatoric spinal mobilization: a 30 minutes treatment consisting of 30" series of translatoric mobilizations of the upper cervical spine with 10" rest between sets. For that purpose, the patient is positioned in supine, with the cervical spine in neutral position. The therapist place a hand dorsally at the level of the vertebral arch of C1 with the metacarpophalangeal and radial border of the index finger. The other hand is placed posteriorly under the occiput, with the shoulder positioned anteriorly on the patient's forehead. The mobilization force is directed dorsally from the shoulder until the therapist feel a marked resistance and then apply slightly more pressure in order to perform a stretching mobilization.
No Intervention: Control
The control group receive no treatment intervention during 30 minutes (a similar time as the UC-TSM group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Headache intensity as measured by Visual Analog Scale
Time Frame: From Baseline to one month follow-up
From Baseline to one month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Cervical mobility as measured by cervical range of motion device (CROM)
Time Frame: 1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Pressure pain threshold as measured by digital algometer (Somedic Farsta)
Time Frame: 1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Temporomandibular joint mobility as measured by digital calipher (mouth opening)
Time Frame: 1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Global Perceived Effect as measured by Global Perceived Effect Scale (-5 to +5 Likert Scale)
Time Frame: One month follow-up
One month follow-up
Immediate headache intensity changes as measured by Visual Analog Scale
Time Frame: 1 minute Pre-Intervention, 1 minute Post-Intervention
1 minute Pre-Intervention, 1 minute Post-Intervention

Collaborators and Investigators

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

Sponsor

Universidad de Zaragoza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMU.01.001

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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