Effects of Osteopathic Treatment in Patients With Tension Type Headache

Sponsor
Escola Superior de Tecnologia da Saúde do Porto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05906901
Collaborator
(none)
30
1
2
10
3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cranial listening technique
  • Other: Suboccipital muscles inhibition technique
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Osteopathic Treatment in Patients With Tension Type Headache
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control Group

The investigator will perform a cranial listening technique.

Other: Cranial listening technique
5 minutes

Experimental: Suboccipital muscles inhibition

The investigator will perform a suboccipital muscles inhibition technique.

Other: Suboccipital muscles inhibition technique
6 minutes

Outcome Measures

Primary Outcome Measures

  1. Frequency [One month after first intervention]

    Measured by monthly counting.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Escola Superior da Saúde do Porto Porto Portugal 4200-072

Sponsors and Collaborators

  • Escola Superior de Tecnologia da Saúde do Porto

Investigators

  • Principal Investigator: Natália MO Campelo, Escola Superior da Saúde do Porto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Natália Maria Oliveira Campelo, Professor, Escola Superior de Tecnologia da Saúde do Porto
ClinicalTrials.gov Identifier:
NCT05906901
Other Study ID Numbers:
  • OST1-009
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023