Suboccipital Inhibition in Tension Headache

May 1, 2020 updated by: Cristina Blanco Ortega, Universidad de León
The researchers will carry out a randomized experimental study. Participants in the experimental group will receive a treatment based on suboccipital inhibition technique in addition to conventional treatment. Participants in the control group will only receive the conventional treatment. The existence of significant differences in both groups will be analyzed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Conventional therapy will consist of microwaves, interference currents, and manual therapy.

Study Type

Interventional

Enrollment (Anticipated)

30

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
      • León, Spain, 24001
        • Cristina Blanco Ortega

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pathology tension headache associated with cervicalgia

Exclusion Criteria:

  • pathology of nervous system

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Suboccipital inhibition in tension headache

Two groups of patients suffering from tension headache associated with cervicalgia are selected.

The control group performs conventional therapy. The experimental group performs conventional therapy plus the technique of suboccipital inhibition
Other: Suboccipital inhibition in tension headache
Deep maneuver of myofascial induction in the suboccipital muscles
ACTIVE_COMPARATOR: study of results
We compared data from both groups
Other: Suboccipital inhibition in tension headache
Deep maneuver of myofascial induction in the suboccipital muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analogue Scale for Pain
Time Frame: immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start
a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "worst imaginable pain" (score of 10)
immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Six-item Headache Impact Text
Time Frame: immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start
A global measure of adverse headache impact. The final HIT-6 score is obtained from simple summation of the six items and ranges between 36 and 78, with larger scores reflecting greater impact.
immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start

Collaborators and Investigators

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

Sponsor

Universidad de León

Collaborators

Sanidad de Castilla y León

Investigators

  • Principal Investigator: Cristina Blanco Ortega, physiotherap, Universidad de León

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)

February 1, 2019

Primary Completion (ACTUAL)

November 22, 2019

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

February 24, 2019

First Submitted That Met QC Criteria

May 1, 2020

First Posted (ACTUAL)

May 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 1, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71441538L

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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