Effects of Osteopathic Treatment in Patients With Tension Type Headache
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2023
CompletedFirst Posted
Study publicly available on registry
June 18, 2023
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 8, 2024
April 1, 2024
3 months
June 2, 2023
April 5, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Control Group
PLACEBO COMPARATORThe investigator will perform a cranial listening technique.
Suboccipital muscles inhibition
EXPERIMENTALThe investigator will perform a suboccipital muscles inhibition technique.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- bilateral location
- pressure or squeezing quality (non throbbing)
- weak or moderate intensity
- not aggravated by routine physical activity such as walking or climbing stairs;
- must have both of the following criteria:
- only one of the following: photophobia, phonophobia, or mild nausea
- absence of moderate or severe nausea or vomiting.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Escola Superior da Saúde do Porto
Porto, 4200-072, Portugal
Related 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.
PMID: 23771276RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natália MO Natália
Escola Superior da Saúde do Porto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 2, 2023
First Posted
June 18, 2023
Study Start
September 1, 2024
Primary Completion
December 1, 2024
Study Completion
December 31, 2024
Last Updated
April 8, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share