Dry Needling on the Treatment of Chronic Somatosensory Tinnitus: An Open Pilot Study

NCT03295890 | Unknown

• 1 other identifier: USaoPauloGHGZ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Self paring study, double blind placebo controlled with chronic tinnitus patients attended at the Tinnitus Research Group HC- FMUSP, complaining of neck and/or cervical pain and with myofascial trigger point in the head, neck and/or shoulder. They were submitted to a complete otolaryngologist evaluation which included history, physical examination and myofascial trigger point checkup. Patients also performed blood tests, tonal and vocal audiometry, and psychoacoustic tinnitus measures. Self paring study, double blind placebo controlled. Each patient will be subjected to the dry needling placebo, 4 sessions, 1 per week, with placebo stretching, followed by washout period of two weeks, and 4 more dry needling therapeutic sessions and active stretching. On the first day of the study will be conducted the following evaluation: questionnaires THI and NDI, quantification of cervical pain and tinnitus through the Visual analogue scale (VAS), search and confirmation of the presence of PGM and cervical pain, psychoacoustic measures and somatic tests. This evaluation will be repeated at the end of the four placebo sessions, at the beginning of therapeutic needling sessions and at the end of the same.

Conditions

Tinnitus; Trigger Point Pain, Myofascial; Somatosensory Disorders

Keywords

myofascial trigger point, tinnitus, dry needling

Outcome Measures

Primary Outcomes (1)

• Placebo Dry Needling

  Placebo Needling on trigger points

  4 weeks

Secondary Outcomes (1)

• Active Dry needling

  4 weeks

Study Arms (2)

Sham Needling

SHAM COMPARATOR

Intervention = Sham Needling

Procedure: Dry Needing

Active Needling

ACTIVE COMPARATOR

Intervention = Active Needling

Procedure: Dry Needing

Interventions

Dry Needing PROCEDURE

Dry Needling

Active Needling; Sham Needling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With constant tinnitus, unilateral or bilateral, for more than 6 months,
• Both sexes,
• Over 18 years,
• Presence of at least one PGM (active or latent),
• Diagnosis of Myofascial pain syndrome, according to the criteria of Travell and Simons.

You may not qualify if:

• With prior experience with the use of needles for therapeutic purposes,
• With formal contraindication to dry needling, as chronic use of anticoagulants or hematologic diseases,
• Those who refuse the proposed therapies, for example, phobia of needles,
• In use of medications for pain able to interfere with the result of the study, such as anti-inflammatory and or muscle relaxers, until 30 days before the initial assessment,

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Tinnitus; Myofascial Pain Syndromes; Somatosensory Disorders

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Ricardo Bento, MD PhD

  University of Sao Paulo

  STUDY CHAIR

Central Study Contacts

Jeanne Oiticica, MD PhD

CONTACT

5511974361596; jeanne.ramalho@uol.com.br

Juliana Aguiar, MD

CONTACT

5511982921245; juliana.anauate@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 28, 2017
• Study Start: July 29, 2016
• Primary Completion: June 5, 2018
• Study Completion: July 29, 2020
• Last Updated: September 28, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)