Sub-occipital Muscle Inhibition in Tension Type Headache (TTH)

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.

Study Overview

• Status: Completed
• Conditions: Tension-Type Headache
• Intervention / Treatment: Other: Suboccipital inhibition

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Guadalupe
    • Murcia, Guadalupe, Spain, 30107
      • Universidad Católica San Antonio de Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
No Intervention: Control; 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?

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.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia
• Investigators: Study Director: Javier Meroño-Gallut, PhD, Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Physical Therapy Modalities; Musculoskeletal Manipulations; Tension-Type Headache; Sub-occipital muscle inhibition technique
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: tension type headache