Effects of Osteopathic Treatment in Patients With Tension Type Headache

Tension-Type Headache Clinical Trial

Official title:

Effects of Osteopathic Treatment in Patients With Tension Type Headache

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05906901
• Other study ID #: OST1-009
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

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