Auriculotherapy in Tension-type Headache Due to Temporomandibular Dysfunction

Tension-Type Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309775
• Other study ID #: Universidade Federal Alfenas
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: December 5, 2014
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Tension-Type Headache

Intervention

Other:
• Auriculotherapy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of muscle contraction (Electromyographic signals of the masseter and temporalis muscles bilaterally.)	Electromyographic signals of the masseter and temporalis muscles bilaterally.	one day	No
Secondary	Pain at the time (Visual analog pain scale)	Pain at the time will using Visual analog pain scale.	one week	No