Sub-occipital Muscle Inhibition in Tension Type Headache

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment Efficacy of Tension Type Headache After Application of Sub-occipital Muscle Inhibition Technique Associated With Interferential Electrotherapy

Conditions
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Tension-Type Headache

Intervention / Treatment
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* Other: Suboccipital inhibition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with tension type headache In prophylactic regimen and with medical control Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suboccipital inhibition<br>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<br>* 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.<br>|
| No Intervention: Control<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | STAI will be assessed at baseline and after 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | BECK II will be assessed at baseline and after 4 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tension-Type Headache, Physical Therapy Modalities, Musculoskeletal Manipulations, Sub-occipital muscle inhibition technique