Auriculotherapy in Tension-type Headache Due to Temporomandibular Dysfunction

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).

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Key information

Conditions

Tension-type Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auriculotherapy

Other

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 outcomes

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

Time frame: one day

Electromyographic signals of the masseter and temporalis muscles bilaterally.

Secondary outcomes

Pain at the time (Visual analog pain scale)

Time frame: one week

Pain at the time will using Visual analog pain scale.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Auriculotherapy in Tension-type Headache Due to Temporomandibular Dysfunction - A Randomized Study

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Dec 5, 2014
Registry last updated: Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed