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

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.

Study Overview

• Status: Unknown
• Conditions: Tinnitus; Somatosensory Disorders; Trigger Point Pain, Myofascial
• Intervention / Treatment: Procedure: Dry Needing

Detailed Description

The first phase of the study will be the placebo needling, performed with a sham needle and following the same procedures than the therapeutic treatment. Four placebo sessions will be performed, 1 per week, with placebo stretching, followed by washout period of two weeks, and 4 more dry needling therapeutic sessions, also once a week and active stretching. The muscles selected for dry needling were frontal, temporal, trapezius, masseter, sternocleidomastoid (SCM), head splenius, scalene, medial pterygoid, lateral pterygoid, rhomboid.

Procedure technique Each patient was recommended to assume a relaxed posture suitable to access the muscles being treated, instructed to expose the painful area, settled himself in supine, prone, or side lying positions, at a stretcher or a chair, depending on the muscle to be treated. The main therapist performed MTP target with a pen, hands antisepsis, gloves wear and skin area cleaning with 70% isopropyl alcohol prior to needling. Along all procedure the main therapist was able to view the patient's face and to receive regular treating feedback. A sterile disposable filament needle was inserted directly perpendicular through the skin using a guide tube that was then removed. Depth needle penetration with slow sidelong direction in and outside displacements were performed through the muscle until reach MTP spot. The patient's reaction indicated a "DEQI" (name given for the vague sensation of needle-specific pain) or a "twitch response" (deflagration of a contractile muscle answer in the moment that maximum muscle shortening fibers were broken). At this point needle was leaved static in situ for 30-60 seconds. After the correct treatment needle was removed and the muscle was active stretched.

Variables studied before and after therapeutic needling were:

1. Tinnitus annoying as measured by AVS.
2. Pain magnitude as measured by AVS.
3. Tinnitus impact on patient's quality of life through THI questionnaire validated for Portuguese language.
4. Cervical pain impact on patient's quality of life through NDI questionnaire validated for Portuguese language.
5. Tinnitus MML through psychoacoustic measures.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 05403000
      • Recruiting
      • University of Sao Paulo
      • Contact: Jeanne Oiticica, MD PhD; Phone Number: +551130880299; Email: jeanneramalho@uol.com.br
      • Contact: Juliana Anauate, MD; Phone Number: +5511982921245; Email: juliana.anauate@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Needling; Intervention = Sham Needling	Procedure: Dry Needing; Dry Needling
Active Comparator: Active Needling; Intervention = Active Needling	Procedure: Dry Needing; Dry Needling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placebo Dry Needling	Placebo Needling on trigger points	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active Dry needling	Therapeutic needling on trigger points	4 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Chair: Ricardo Bento, MD PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2016
• Primary Completion (Anticipated): June 5, 2018
• Study Completion (Anticipated): July 29, 2020

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: myofascial trigger point, tinnitus, dry needling
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Myofascial Pain Syndromes; Tinnitus; Somatosensory Disorders
• Other Study ID Numbers: USaoPauloGHGZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No