Clinical trial NCT02309775: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pattern of muscle contraction (Electromyographic signals of the masseter and temporalis muscles bilaterally.)
timeFrame: one day
Secondary outcomes:
measure: Pain at the time (Visual analog pain scale)
timeFrame: one week
Other outcomes:
Locations:
Study officials:
References: