Back to resultsEffects of Osteopathic Treatment in Patients With Tension Type Headache
Primary Purpose
Tension-Type Headache
Status
Not yet recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Cranial listening technique
Suboccipital muscles inhibition technique
Sponsored by
About this trial
This is an interventional treatment trial for Tension-Type Headache
Eligibility Criteria
Inclusion Criteria: They must have tension-type headache, that is, a headache with: a duration of at least 30 min to days, with or without an break; must have at least two of the following four characteristics: bilateral location pressure or squeezing quality (non throbbing) weak or moderate intensity not aggravated by routine physical activity such as walking or climbing stairs; must have both of the following criteria: only one of the following: photophobia, phonophobia, or mild nausea absence of moderate or severe nausea or vomiting. Exclusion Criteria: They can't be on antibiotics, antivirals, or antidepressants; They can't have neurological problems; They shouldn't have any absolute contraindication for the osteopathic maneuvers; They can't have acute pathologies (ex: infection) or serious (ex: cancer); They can't have fractures in the skull, cervical spine or high dorsal spine (up to D4); They can't be pregnant.
Sites / Locations
- Escola Superior da Saúde do Porto
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Group
Suboccipital muscles inhibition
Arm Description
The investigator will perform a cranial listening technique.
The investigator will perform a suboccipital muscles inhibition technique.
Outcomes
Primary Outcome Measures
Frequency
Measured by monthly counting.
Intensity
Measured by visual analogue scale (VAS). It goes from 0 to 10, 0 being the minimum pain intensity and 10 the maximum pain intensity.
Impact on quality of life questionnaire
Measured by questionnaire. The questionnaire attribuates a score after answering six questions. The lowest score a participant can obtain is 36, which corresponds to the lowest impact on quality of life. The highest score a participant can obtain is 78, which corresponds to the highest impact on quality of life.
Secondary Outcome Measures
Full Information
NCT ID
NCT05906901
First Posted
June 2, 2023
Last Updated
June 13, 2023
Sponsor
Escola Superior de Tecnologia da Saúde do Porto
1. Study Identification
Unique Protocol Identification Number
NCT05906901
Brief Title
Effects of Osteopathic Treatment in Patients With Tension Type Headache
Official Title
Effects of Osteopathic Treatment in Patients With Tension Type Headache
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Tecnologia da Saúde do Porto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the effects of the suboccipital muscles inhibition technique on patients suffering from tension-type headaches.
Detailed Description
The tension-type headache is a recurrent condition with a high financial repercussion in Portugal. Their side effects often impact daily activities, reducing the quality of life of the patients.
In several studies, the excessive tension of the suboccipital muscles are usually referred as a cause of tension-type headache, since they can exert tension on the dura mater through the myodural bridge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The investigator will perform a cranial listening technique.
Arm Title
Suboccipital muscles inhibition
Arm Type
Experimental
Arm Description
The investigator will perform a suboccipital muscles inhibition technique.
Intervention Type
Other
Intervention Name(s)
Cranial listening technique
Intervention Description
5 minutes
Intervention Type
Other
Intervention Name(s)
Suboccipital muscles inhibition technique
Intervention Description
6 minutes
Primary Outcome Measure Information:
Title
Frequency
Description
Measured by monthly counting.
Time Frame
One month after first intervention
Title
Intensity
Description
Measured by visual analogue scale (VAS). It goes from 0 to 10, 0 being the minimum pain intensity and 10 the maximum pain intensity.
Time Frame
One month after first intervention
Title
Impact on quality of life questionnaire
Description
Measured by questionnaire. The questionnaire attribuates a score after answering six questions. The lowest score a participant can obtain is 36, which corresponds to the lowest impact on quality of life. The highest score a participant can obtain is 78, which corresponds to the highest impact on quality of life.
Time Frame
one month after first intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
They must have tension-type headache, that is, a headache with:
a duration of at least 30 min to days, with or without an break;
must have at least two of the following four characteristics:
bilateral location
pressure or squeezing quality (non throbbing)
weak or moderate intensity
not aggravated by routine physical activity such as walking or climbing stairs;
must have both of the following criteria:
only one of the following: photophobia, phonophobia, or mild nausea
absence of moderate or severe nausea or vomiting.
Exclusion Criteria:
They can't be on antibiotics, antivirals, or antidepressants;
They can't have neurological problems;
They shouldn't have any absolute contraindication for the osteopathic maneuvers;
They can't have acute pathologies (ex: infection) or serious (ex: cancer);
They can't have fractures in the skull, cervical spine or high dorsal spine (up to D4);
They can't be pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natália MO Campelo, PhD
Phone
351 22 206 1000
Email
ncampelo.estsp.ipp@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Natália MO Campelo
Phone
351 22 206 1000
Email
ncampelo.estsp.ipp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natália MO Campelo
Organizational Affiliation
Escola Superior da Saúde do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escola Superior da Saúde do Porto
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23771276
Citation
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
Results Reference
result
Learn more about this trial
Effects of Osteopathic Treatment in Patients With Tension Type Headache
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