Back to resultsSuboccipital Inhibition in Tension Headache
Primary Purpose
Tension Headache
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Suboccipital inhibition in tension headache
Sponsored by
About this trial
This is an interventional treatment trial for Tension Headache focused on measuring tension headache, suboccipital inhibition
Eligibility Criteria
Inclusion Criteria:
- pathology tension headache associated with cervicalgia
Exclusion Criteria:
- pathology of nervous system
Sites / Locations
- Cristina Blanco Ortega
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Suboccipital inhibition in tension headache
study of results
Arm Description
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
We compared data from both groups
Outcomes
Primary Outcome Measures
Change in Visual Analogue Scale for Pain
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)
Secondary Outcome Measures
Change in Six-item Headache Impact Text
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.
Full Information
NCT ID
NCT04376125
First Posted
February 24, 2019
Last Updated
May 1, 2020
Sponsor
Universidad de León
Collaborators
Sanidad de Castilla y León
1. Study Identification
Unique Protocol Identification Number
NCT04376125
Brief Title
Suboccipital Inhibition in Tension Headache
Official Title
Suboccipital Inhibition in Tension Headache
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de León
Collaborators
Sanidad de Castilla y León
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Conventional therapy will consist of microwaves, interference currents, and manual therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension Headache
Keywords
tension headache, suboccipital inhibition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Suboccipital inhibition in tension headache
Arm Type
Experimental
Arm Description
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
Arm Title
study of results
Arm Type
Active Comparator
Arm Description
We compared data from both groups
Intervention Type
Other
Intervention Name(s)
Suboccipital inhibition in tension headache
Intervention Description
Deep maneuver of myofascial induction in the suboccipital muscles
Primary Outcome Measure Information:
Title
Change in Visual Analogue Scale for Pain
Description
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)
Time Frame
immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start
Secondary Outcome Measure Information:
Title
Change in Six-item Headache Impact Text
Description
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.
Time Frame
immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pathology tension headache associated with cervicalgia
Exclusion Criteria:
pathology of nervous system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Blanco Ortega, physiotherap
Organizational Affiliation
Universidad de León
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cristina Blanco Ortega
City
León
ZIP/Postal Code
24001
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Suboccipital Inhibition in Tension Headache
We'll reach out to this number within 24 hrs