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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05906901
Other study ID # OST1-009
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Escola Superior de Tecnologia da Saúde do Porto
Contact Natália MO Campelo, PhD
Phone 351 22 206 1000
Email nmc@ess.ipp@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effects of the suboccipital muscles inhibition technique on patients suffering from tension-type headaches.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 31, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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: 1. bilateral location 2. pressure or squeezing quality (non throbbing) 3. weak or moderate intensity 4. not aggravated by routine physical activity such as walking or climbing stairs; - must have both of the following criteria: 1. only one of the following: photophobia, phonophobia, or mild nausea 2. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cranial listening technique
5 minutes
Suboccipital muscles inhibition technique
6 minutes

Locations

Country Name City State
Portugal Escola Superior da Saúde do Porto Porto

Sponsors (1)

Lead Sponsor Collaborator
Escola Superior de Tecnologia da Saúde do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency Measured by monthly counting. One month after first intervention
Primary 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. One month after first intervention
Primary 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. one month after first intervention
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