Tension HeadacheNCT04376125
Suboccipital Inhibition in Tension Headache
A study testing Suboccipital inhibition in tension headache in people with Tension Headache, run by Universidad de León at 1 site in Spain.
Trial summary
The researchers will carry out a randomized experimental study. Participants in the experimental group will receive a treatment based on suboccipital inhibition technique in addition to conventional treatment. Participants in the control group will only receive the conventional treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tension Headache
- What is being tested?
- Suboccipital inhibition in tension headache
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pathology tension headache associated with cervicalgia
Who cannot join
- pathology of nervous system
Trial locations and contacts
1 site in 1 country.
About this study
The researchers will carry out a randomized experimental study. Participants in the experimental group will receive a treatment based on suboccipital inhibition technique in addition to conventional treatment. Participants in the control group will only receive the conventional treatment. The existence of significant differences in both groups will be analyzed.
Read the detailed description
Conventional therapy will consist of microwaves, interference currents, and manual therapy.
- Conditions
- Tension Headache
- Being tested
- Suboccipital inhibition in tension headache
- Keywords
- tension headache, suboccipital inhibition
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suboccipital inhibition in tension headacheOther
Deep maneuver of myofascial induction in the suboccipital muscles
| Study group | Role | What they receive |
|---|---|---|
| Suboccipital inhibition in tension headache | Experimental | Two groups of patients suffering from tension headache associated with cervicalgia are selected.
The control group performs conventional therapy. The experimental group performs conventional therapy plus the technique of suboccipital inhibition Receives: Other: Suboccipital inhibition in tension headache |
| study of results | Active comparator | We compared data from both groups Receives: Other: Suboccipital inhibition in tension headache |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale for Pain
a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "worst imaginable pain" (score of 10)
Measured: immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start
Secondary outcomes (1)
Change in Six-item Headache Impact Text
A global measure of adverse headache impact. The final HIT-6 score is obtained from simple summation of the six items and ranges between 36 and 78, with larger scores reflecting greater impact.
Measured: immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Feb 2019
- Primary completion22 Nov 2019
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Collaborators
- Sanidad de Castilla y León
- Responsible party
- Principal investigator, Cristina Blanco Ortega, Universidad de León
- Investigators
- Cristina Blanco Ortega, physiotherap, Principal investigator, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376125
- Sponsor's protocol ID
- 71441538L
- Status last verified
- May 2020
- First submitted
- 24 Feb 2019
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suboccipital Inhibition in Tension Headache
- ClinicalTrials.gov ID
- NCT04376125
- Acronym / sponsor ID
- 71441538L
- Conditions
- Tension Headache
- Keywords
- tension headache, suboccipital inhibition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Collaborators
- Sanidad de Castilla y León
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers will carry out a randomized experimental study. Participants in the experimental group will receive a treatment based on suboccipital inhibition technique in addition to conventional treatment. Participants in the control group will only receive the conventional treatment. The existence of significant differences in both groups will be analyzed.
Detailed description
Conventional therapy will consist of microwaves, interference currents, and manual therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suboccipital inhibition in tension headache | Experimental | Other: Suboccipital inhibition in tension headacheTwo groups of patients suffering from tension headache associated with cervicalgia are selected. The control group performs conventional therapy. The experimental group performs conventional therapy plus the technique of suboccipital inhibition |
| study of results | Active comparator | Other: Suboccipital inhibition in tension headacheWe compared data from both groups |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pathology tension headache associated with cervicalgia
Key exclusion criteria (1 listed)
- pathology of nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suboccipital inhibition in tension headacheDeep maneuver of myofascial induction in the suboccipital muscles | Other | Suboccipital inhibition in tension headache, study of results |
Primary outcome
Change in Visual Analogue Scale for Pain
Time frame: immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start
a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "worst imaginable pain" (score of 10)
1 secondary outcome
Change in Six-item Headache Impact Text
Time frame: immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Blanco Ortega, physiotherap principal investigator
Universidad de León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suboccipital inhibition in tension headache in people with Tension Headache, run by Universidad de León at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analogue Scale for Pain (time frame: immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.