Effects of Osteopathic Treatment in Patients With Tension Type Headache

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

Study Overview

• Status: Not yet recruiting
• Conditions: Tension-Type Headache
• Intervention / Treatment: Other: Cranial listening technique; Other: Suboccipital muscles inhibition technique

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natália MO Campelo, PhD; Phone Number: 351 22 206 1000; Email: nmc@ess.ipp@gmail.com
• Study Contact Backup: Name: Natália MO Campelo; Phone Number: 351 22 206 1000; Email: nmc@ess.ipp@gmail.com

Study Locations

• Portugal
  • Porto, Portugal, 4200-072
    • Escola Superior da Saúde do Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency	Measured by monthly counting.	One month after first intervention
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
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

Collaborators and Investigators

• Sponsor: Escola Superior de Tecnologia da Saúde do Porto
• Investigators: Principal Investigator: Natália MO Natália, Escola Superior da Saúde do Porto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: OST1-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No