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

Primary Purpose

Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Suboccipital inhibition
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache focused on measuring Tension-Type Headache, Physical Therapy Modalities, Musculoskeletal Manipulations, Sub-occipital muscle inhibition technique

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Católica San Antonio de Murcia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Suboccipital inhibition

Control

Arm Description

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 will be done to the participants during the study. After study completion, the participants will be offered to receive the therapy.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 15, 2014
Last Updated
April 26, 2018
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT02195648
Brief Title
Sub-occipital Muscle Inhibition in Tension Type Headache
Acronym
TTH
Official Title
Treatment Efficacy of Tension Type Headache After Application of Sub-occipital Muscle Inhibition Technique Associated With Interferential Electrotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache
Keywords
Tension-Type Headache, Physical Therapy Modalities, Musculoskeletal Manipulations, Sub-occipital muscle inhibition technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Outcome assessor will be blinded to group allocation. Additionally, analysis blinding will be performed to group allocation.
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suboccipital inhibition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be done to the participants during the study. After study completion, the participants will be offered to receive the therapy.
Intervention Type
Other
Intervention Name(s)
Suboccipital inhibition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
Our primary outcome will consist of changes at each session in self-reported pain, which will be measured with a visual analogic scale (VAS).
Time Frame
Pain will be assessed at baseline, before and after each session (twice a week for 4 weeks)
Title
Anxiety
Description
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).
Time Frame
STAI will be assessed at baseline and after 4 weeks.
Secondary Outcome Measure Information:
Title
Headache Disability
Description
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.
Time Frame
HDI will be assessed at baseline and after 4 weeks.
Title
Headache Impact Test
Description
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.
Time Frame
HIT-6 will be assessed at baseline and after 4 weeks.
Title
Range of Motion
Description
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.
Time Frame
ROM will be assessed at baseline and after 4 weeks.
Title
Neck Disability Index
Description
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.
Time Frame
NDI will be assessed at baseline and after 4 weeks.
Title
SF-36 Health Survey
Description
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.
Time Frame
SF-36 will be assessed at baseline and after 4 weeks.
Title
Depression
Description
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.
Time Frame
BECK II will be assessed at baseline and after 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Meroño-Gallut, PhD
Organizational Affiliation
Universidad Católica San Antonio de Murcia
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Católica San Antonio de Murcia
City
Murcia
State/Province
Guadalupe
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

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Sub-occipital Muscle Inhibition in Tension Type Headache

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