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Auriculotherapy in Tension-type Headache Due to Temporomandibular Dysfunction

Primary Purpose

Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auriculotherapy
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals with tension-type headache due to temporomandibular dysfunction, aged 20 to 30 years, of both sexes

Exclusion Criteria:

  • Individuals with migraine type headache, secondary headaches
  • Use of medicines more than 10 days per month and any type of acupuncture treatment in the last 12 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Auriculotherapy Group

    Placebo Grup

    Arm Description

    The placement, points according to Souza (1997), will be: Shen Men, Sympathetic, Kidney, Subcortex, Adrenal and Cerebral. The point descriptions are: Shen Men, is located in the vertex of the angle formed by the lower root and the upper root of the antihelix; the Sympathetic is situated in the middle of the lower root below the Helix membrane (located at the lower end of the Lobe); the Kidney point is situated in cymba concha, near its junction with the lower root of the antihelix, in the same line as the Shen Men point; the Subcortex is situated on upward curve towards the apex of the antitragus, on the upper edge of the concha; the Adrenal is located at the apex of the tragus, on its projection towards the concha cava; the Cerebral point is situated above the edge of the antitragus. As sessions will held twice a week for a total of 10 sessions.

    The point stimulated will be the Trachea, which is one millimeter in the direction of the auditory meatus. This point does not cause risk to the research participant. As sessions will held twice a week for a total of 10 sessions.

    Outcomes

    Primary Outcome Measures

    Pattern of muscle contraction (Electromyographic signals of the masseter and temporalis muscles bilaterally.)
    Electromyographic signals of the masseter and temporalis muscles bilaterally.

    Secondary Outcome Measures

    Pain at the time (Visual analog pain scale)
    Pain at the time will using Visual analog pain scale.

    Full Information

    First Posted
    November 18, 2014
    Last Updated
    December 5, 2014
    Sponsor
    Federal University of Minas Gerais
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02309775
    Brief Title
    Auriculotherapy in Tension-type Headache Due to Temporomandibular Dysfunction
    Official Title
    Auriculotherapy in Tension-type Headache Due to Temporomandibular Dysfunction - A Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Minas Gerais

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objectives: Verify the effect of auriculotherapy in patients with tension-type headache resulting from temporomandibular dysfunction. Design: Randomized clinical study Setting: Randomized Study Participants: The study consist of 38 participants randomized into two groups: an intervention group (n = 18, sample loss = 1) and placebo group (n = 20, sample loss = 6) Interventions: The intervention group will receive treatment with auricular acupuncture in the Shen Men, Kidney, Sympathetic, Subcortex, Adrenal and Cerebral points. The placebo group will receive auriculotherapy in the trachea point. Main outcome measures: visual analog scale for pain pain (VAS) and surface electromyography (EMG).
    Detailed Description
    This is an experimental clinical trial in which will be selected at the University, 40 students with tension-type headache due to temporomandibular dysfunction. Among the selected subjects will be randomized by blind draw into two groups: intervention group (IG) and placebo group (GII). The instruments that will be used for the evaluation are the visual analog pain scale, the Survey questionnaire for Temporomandibular Disorders (RDC) 3, and surface electromyography (EMG System of Brazil). The EMG signals will be collected in the rest position (3 samples) and maximum voluntary isometric contraction (3 collections). The masseter and temporalis muscles bilaterally will be evaluated according to the protocol of Rodrigues. For treatment of Ear, initially cleaning the pinna is made to be manipulated with 70% alcohol and later will be inserted mustard seed with a tape in the following points: Shenmen, Sympathetic, Kidney, subcortex, Adrenal and Brain second Souza in GI and GII point of the trachea. Such treatment will last 15 minutes each session, being held 2 times a week, alternating the ear to be manipulated over a period of 5 weeks. For comparison between groups the Mann-Whitney test statistic with Software BioStat 4.0 software will be used. With a significance level (p <0.05).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tension-Type Headache

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Auriculotherapy Group
    Arm Type
    Active Comparator
    Arm Description
    The placement, points according to Souza (1997), will be: Shen Men, Sympathetic, Kidney, Subcortex, Adrenal and Cerebral. The point descriptions are: Shen Men, is located in the vertex of the angle formed by the lower root and the upper root of the antihelix; the Sympathetic is situated in the middle of the lower root below the Helix membrane (located at the lower end of the Lobe); the Kidney point is situated in cymba concha, near its junction with the lower root of the antihelix, in the same line as the Shen Men point; the Subcortex is situated on upward curve towards the apex of the antitragus, on the upper edge of the concha; the Adrenal is located at the apex of the tragus, on its projection towards the concha cava; the Cerebral point is situated above the edge of the antitragus. As sessions will held twice a week for a total of 10 sessions.
    Arm Title
    Placebo Grup
    Arm Type
    Placebo Comparator
    Arm Description
    The point stimulated will be the Trachea, which is one millimeter in the direction of the auditory meatus. This point does not cause risk to the research participant. As sessions will held twice a week for a total of 10 sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Auriculotherapy
    Intervention Description
    First cleaning of the ear is made with 70% alcohol. The seed will be stuck in the ear with an adhesive (Micropore 3M) tape. The placement, points according to Souza (1997), were: Shen Men, Sympathetic, Kidney, Subcortex, Adrenal and Cerebral. As sessions will held twice a week for a total of 10 sessions.
    Primary Outcome Measure Information:
    Title
    Pattern of muscle contraction (Electromyographic signals of the masseter and temporalis muscles bilaterally.)
    Description
    Electromyographic signals of the masseter and temporalis muscles bilaterally.
    Time Frame
    one day
    Secondary Outcome Measure Information:
    Title
    Pain at the time (Visual analog pain scale)
    Description
    Pain at the time will using Visual analog pain scale.
    Time Frame
    one week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Individuals with tension-type headache due to temporomandibular dysfunction, aged 20 to 30 years, of both sexes Exclusion Criteria: Individuals with migraine type headache, secondary headaches Use of medicines more than 10 days per month and any type of acupuncture treatment in the last 12 months

    12. IPD Sharing Statement

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    Auriculotherapy in Tension-type Headache Due to Temporomandibular Dysfunction

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