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

NCT ID: NCT03295890

Last Updated: 2017-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-29
• Study Completion Date: 2020-07-29

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.

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.

Conditions

Tinnitus; Trigger Point Pain, Myofascial; Somatosensory Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham Needling

Intervention = Sham Needling

Group Type: SHAM_COMPARATOR

Dry Needing

Intervention Type: PROCEDURE

Dry Needling

Active Needling

Intervention = Active Needling

Group Type: ACTIVE_COMPARATOR

Dry Needing

Intervention Type: PROCEDURE

Dry Needling

Interventions

Dry Needing

Dry Needling

Intervention Type: PROCEDURE

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo Bento, MD PhD

Role: STUDY_CHAIR

University of Sao Paulo

Locations

University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Jeanne Oiticica, MD PhD

Role: CONTACT

jeanne.ramalho@uol.com.br

5511974361596

Juliana Aguiar, MD

Role: CONTACT

juliana.anauate@gmail.com

5511982921245

Facility Contacts

Jeanne Oiticica, MD PhD

Role: primary

jeanneramalho@uol.com.br

+551130880299

Juliana Anauate, MD

Role: backup

juliana.anauate@gmail.com

+5511982921245

Other Identifiers

USaoPauloGHGZ

Identifier Type: -

Identifier Source: org_study_id