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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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