Sub-occipital Muscle Inhibition in Tension Type Headache

Tension-Type Headache Clinical Trial

— TTH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195648
• Other study ID #: tension type headache
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

Other:
• Suboccipital inhibition
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.

Locations

Country	Name	City	State
Spain	Universidad Católica San Antonio de Murcia	Murcia	Guadalupe

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Anxiety	Anxiety will be assessed with the State-Trait Anxiety Inventory. This questionnaire is designed for the self-assessment of anxiety (Cronbach's a for this scale ranges from .83 to .92).	STAI will be assessed at baseline and after 4 weeks.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.