Tension-Type HeadacheTTHNCT02195648
Sub-occipital Muscle Inhibition in Tension Type Headache
A study testing Suboccipital inhibition in people with Tension-Type Headache, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
The main objective of this study is to determine the effects caused in neck movement, neck pain, headache in patients with tension type headache and cervicogenic headache after application of sub-occipital muscle inhibition technique associated with interferential electrotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Suboccipital inhibition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to Dec 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with tension type headache
- In prophylactic regimen and with medical control
Who cannot join
- Patients with neurological or cognitive impairments that prevent understanding the questionnaires
- Patients diagnosed with other types of headaches
- Patients who have not signed the informed consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Efficacy of Tension Type Headache After Application of Sub-occipital Muscle Inhibition Technique Associated With Interferential Electrotherapy
The main objective of this study is to determine the effects caused in neck movement, neck pain, headache in patients with tension type headache and cervicogenic headache after application of sub-occipital muscle inhibition technique associated with interferential electrotherapy.
Read the detailed description
This study is based on the combined application of sub-occipital muscle inhibition technique associated with interferential electrotherapy improves symptoms in patients with tension type headache and cervicogenic headache.
The purposes of this study are:
- Evaluate the effectiveness of treatment based on the combined application of sub-occipital muscle inhibition technique associated with interferential electrotherapy in patients with tension type headache.
- Evaluate the effects of treatment caused in upper cervical movement.
- Evaluate the effects of treatment caused in neck pain.
- Evaluate the effects of treatment caused in headache.
- Conditions
- Tension-Type Headache
- Being tested
- Suboccipital inhibition
- Keywords
- Tension-Type Headache, Physical Therapy Modalities, Musculoskeletal Manipulations, Sub-occipital muscle inhibition technique
- 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 inhibitionOther
Experimental: Suboccipital inhibition
The intervention group will receive a session of 20 minutes (5 minutes for the patient's reception, 10 for treatment and the following 5 minutes for rest and hemodynamic stabilization), twice a week for 4 weeks. The intervention will consist of suboccipital muscle inhibition and interferential current on the occipital muscles.
| Study group | Role | What they receive |
|---|---|---|
| Suboccipital inhibition | Experimental | The intervention group will receive a session of 20 minutes (5 minutes for the patient's reception, 10 for treatment and the following 5 minutes for rest and hemodynamic stabilization), twice a week for 4 weeks. The intervention will consist of suboccipital muscle inhibition and interferential current on the occipital muscles. Receives: Other: Suboccipital inhibition |
| Control | No intervention | No intervention will be done to the participants during the study. After study completion, the participants will be offered to receive the therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Our primary outcome will consist of changes at each session in self-reported pain, which will be measured with a visual analogic scale (VAS).
Measured: Pain will be assessed at baseline, before and after each session (twice a week for 4 weeks)
Anxiety
Anxiety will be assessed with the State-Trait Anxiety Inventory. This questionnaire is designed for the self-assessment of anxiety (Cronbach's α for this scale ranges from .83 to .92).
Measured: STAI will be assessed at baseline and after 4 weeks.
Secondary outcomes (6)
Headache Disability
The Spanish version of the Headache Disability Inventory (HDI) which has shown a strong consistency/reliability will be used to measure neck disability. The HDI consists of 25 items assessing emotional (13 items) and functional aspects (12 items) with 4 possible response options, the total score ranging from 0 to 52 points and 0 to 48 points for emotional and functional aspects, respectively, with higher scores indicating more disability.
Measured: HDI will be assessed at baseline and after 4 weeks.
Headache Impact Test
The impact of headache on daily life will be measured by the Headache Impact Test-6 (HIT-6) (Cronbach alpha 0.89; test-retest reliability ranging from 0.78 to 0.90). The HIT-6 consists of 6 items with 4 response options. The total score of HIT-6 ranging from 36 to 78 points, where a higher score indicates a greater impact of headache on the daily life of the respondent.
Measured: HIT-6 will be assessed at baseline and after 4 weeks.
Range of Motion
Upper cervical range of motion will be measured with the CROM-device (Performance Attainment Associates. 958 Lydia Drive, Roseville, Minnesota, USA. 55113) which has demonstrated a good intra-tester reliability for cervical extension, flexion, lateral flexion and rotation. The flexion, extension and lateral flexion ranges of motion will be measured actively with the patient sit in a straight-back chair. The subject will be instructed to move their head and neck through all cardinal planes. The range of motionwill be determined either by the patient reporting the onset of pain or firm resistance met by the evaluator. Three measurements will be done, and the average will be selected for future analysis.
Measured: ROM will be assessed at baseline and after 4 weeks.
Neck Disability Index
Neck Dissability Index (NDI) is a modification of the Oswestry low back pain disability index, and has the most commonly used self-report measure for neck pain. It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The tool is 5-ordinal scale from 1 (I can't) to 5 (I can), with a maximum score 50.
The NDI has good reliability and validity in persons with mechanical neck pain.
Measured: NDI will be assessed at baseline and after 4 weeks.
SF-36 Health Survey
The SF36 is a shortened version of a battery of 149 health status questions developed and tested on a population of over 22,000 patients as part of the medical outcome study.
Measured: SF-36 will be assessed at baseline and after 4 weeks.
Depression
BECK II will be used to measure the participant's depression. The Beck Depression Inventory consists of 21 items, assessing depressive symptoms on a Likert scale of 0-3, ranging from 0 = "rarely or not at all" to 3 = "most of the time or always", with overall scores ranging from 0 to a maximum of 63 points.
Measured: BECK II will be assessed at baseline and after 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startFeb 2015
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raúl Pérez Llanes, Universidad Católica San Antonio de Murcia
- Investigators
- Javier Meroño-Gallut, PhD, Study director, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195648
- Sponsor's protocol ID
- tension type headache
- Acronym
- TTH
- Status last verified
- Apr 2018
- First submitted
- 15 Jul 2014
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Efficacy of Tension Type Headache After Application of Sub-occipital Muscle Inhibition Technique Associated With Interferential Electrotherapy
- ClinicalTrials.gov ID
- NCT02195648
- Acronym / sponsor ID
- TTH / tension type headache
- Conditions
- Tension-Type Headache
- Keywords
- Tension-Type Headache, Physical Therapy Modalities, Musculoskeletal Manipulations, Sub-occipital muscle inhibition technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Jul 2014 (estimated)
- 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 main objective of this study is to determine the effects caused in neck movement, neck pain, headache in patients with tension type headache and cervicogenic headache after application of sub-occipital muscle inhibition technique associated with interferential electrotherapy.
Detailed description
This study is based on the combined application of sub-occipital muscle inhibition technique associated with interferential electrotherapy improves symptoms in patients with tension type headache and cervicogenic headache.
The purposes of this study are:
- Evaluate the effectiveness of treatment based on the combined application of sub-occipital muscle inhibition technique associated with interferential electrotherapy in patients with tension type headache.
- Evaluate the effects of treatment caused in upper cervical movement.
- Evaluate the effects of treatment caused in neck pain.
- Evaluate the effects of treatment caused in headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suboccipital inhibition | Experimental | Other: Suboccipital inhibitionThe intervention group will receive a session of 20 minutes (5 minutes for the patient's reception, 10 for treatment and the following 5 minutes for rest and hemodynamic stabilization), twice a week for 4 weeks. The intervention will consist of suboccipital muscle inhibition and interferential current on the occipital muscles. |
| Control | No intervention | –No intervention will be done to the participants during the study. After study completion, the participants will be offered to receive the therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with tension type headache
- In prophylactic regimen and with medical control
Key exclusion criteria (3 listed)
- Patients with neurological or cognitive impairments that prevent understanding the questionnaires
- Patients diagnosed with other types of headaches
- Patients who have not signed the informed consent document
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 inhibitionExperimental: Suboccipital inhibition The intervention group will receive a session of 20 minutes (5 minutes for the patient's reception, 10 for treatment and the following 5 minutes for rest and hemodynamic stabilization), twice a week for 4 weeks. The intervention will consist of suboccipital muscle inhibition and interferential current on the occipital muscles. | Other | Suboccipital inhibition |
Primary outcome
Pain
Time frame: Pain will be assessed at baseline, before and after each session (twice a week for 4 weeks)
Our primary outcome will consist of changes at each session in self-reported pain, which will be measured with a visual analogic scale (VAS).
Anxiety
Time frame: STAI will be assessed at baseline and after 4 weeks.
Anxiety will be assessed with the State-Trait Anxiety Inventory. This questionnaire is designed for the self-assessment of anxiety (Cronbach's α for this scale ranges from .83 to .92).
6 secondary outcomes
Headache Disability
Time frame: HDI will be assessed at baseline and after 4 weeks.
Headache Impact Test
Time frame: HIT-6 will be assessed at baseline and after 4 weeks.
Range of Motion
Time frame: ROM will be assessed at baseline and after 4 weeks.
Neck Disability Index
Time frame: NDI will be assessed at baseline and after 4 weeks.
SF-36 Health Survey
Time frame: SF-36 will be assessed at baseline and after 4 weeks.
Depression
Time frame: BECK II will be assessed at baseline and after 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
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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.
Javier Meroño-Gallut, PhD study director
Universidad Católica San Antonio de Murcia
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 people with Tension-Type Headache, run by Universidad Católica San Antonio de Murcia 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 30 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain (time frame: Pain will be assessed at baseline, before and after each session (twice a week for 4 weeks)). The study lists 2 primary outcomes in all. 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 30 Apr 2018.