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Sub-occipital Muscle Inhibition in Tension Type Headache

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02195648
Acronym
TTH
Enrollment
29
Registered
2014-07-21
Start date
2015-02-28
Completion date
2017-12-31
Last updated
2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tension-Type Headache

Keywords

Tension-Type Headache, Physical Therapy Modalities, Musculoskeletal Manipulations, Sub-occipital muscle inhibition technique

Brief 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.

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.

Interventions

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.

Sponsors

Universidad Católica San Antonio de Murcia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Outcome assessor will be blinded to group allocation. Additionally, analysis blinding will be performed to group allocation.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PainPain 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).
AnxietySTAI 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).

Secondary

MeasureTime frameDescription
Range of MotionROM will be assessed at baseline and after 4 weeks.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.
Neck Disability IndexNDI will be assessed at baseline and after 4 weeks.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.
Headache DisabilityHDI will be assessed at baseline and after 4 weeks.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.
DepressionBECK II will be assessed at baseline and after 4 weeks.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.
SF-36 Health SurveySF-36 will be assessed at baseline and after 4 weeks.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.
Headache Impact TestHIT-6 will be assessed at baseline and after 4 weeks.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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026