Effects of Osteopathic Treatment in Patients With Tension Type Headache

Not Applicable

Not yet recruiting

• Conditions: Tension-Type Headache
• Interventions: Other: Suboccipital muscles inhibition technique; Other: Cranial listening technique

• Registration Number: NCT05906901
• Lead Sponsor: Escola Superior de Tecnologia da Saúde do Porto

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.

Study Timeline

• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Study Start: 2024-09
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suboccipital muscles inhibition	Suboccipital muscles inhibition technique	The investigator will perform a suboccipital muscles inhibition technique.
Control Group	Cranial listening technique	The investigator will perform a cranial listening technique.

Primary Outcome Measures

Name	Time	Method
Frequency	One month after first intervention	Measured by monthly counting.
Intensity	One month after first intervention	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	one month after first intervention	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.

Trial Locations

Locations (1)

Escola Superior da Saúde do Porto; 🇵🇹 Porto, Portugal