Auriculotherapy in Tension-type Headache Due to Temporomandibular Dysfunction

NCT02309775 | Completed

• 1 other identifier: Universidade Federal Alfenas
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Tension-Type Headache

Outcome Measures

Primary Outcomes (1)

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

  Electromyographic signals of the masseter and temporalis muscles bilaterally.

  one day

Secondary Outcomes (1)

• Pain at the time (Visual analog pain scale)

  one week

Study Arms (2)

Auriculotherapy Group

ACTIVE COMPARATOR

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.

Other: Auriculotherapy

Placebo Grup

PLACEBO COMPARATOR

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.

Interventions

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.

Auriculotherapy Group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Auriculotherapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-graduate student

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: December 5, 2014
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 8, 2014

Record last verified: 2014-12