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

Primary Purpose

Tinnitus, Trigger Point Pain, Myofascial, Somatosensory Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dry Needing
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring myofascial trigger point, tinnitus, dry needling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham Needling

Active Needling

Arm Description

Intervention = Sham Needling

Intervention = Active Needling

Outcomes

Primary Outcome Measures

Placebo Dry Needling
Placebo Needling on trigger points

Secondary Outcome Measures

Active Dry needling
Therapeutic needling on trigger points

Full Information

First Posted
September 22, 2017
Last Updated
September 27, 2017
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03295890
Brief Title
Dry Needling on the Treatment of Chronic Somatosensory Tinnitus: An Open Pilot Study
Official Title
Dry Needling on the Treatment of Chronic Somatosensory Tinnitus: An Open Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 29, 2016 (Actual)
Primary Completion Date
June 5, 2018 (Anticipated)
Study Completion Date
July 29, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Trigger Point Pain, Myofascial, Somatosensory Disorders
Keywords
myofascial trigger point, tinnitus, dry needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham Needling
Arm Type
Sham Comparator
Arm Description
Intervention = Sham Needling
Arm Title
Active Needling
Arm Type
Active Comparator
Arm Description
Intervention = Active Needling
Intervention Type
Procedure
Intervention Name(s)
Dry Needing
Intervention Description
Dry Needling
Primary Outcome Measure Information:
Title
Placebo Dry Needling
Description
Placebo Needling on trigger points
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Active Dry needling
Description
Therapeutic needling on trigger points
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne Oiticica, MD PhD
Phone
5511974361596
Email
jeanne.ramalho@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana Aguiar, MD
Phone
5511982921245
Email
juliana.anauate@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Bento, MD PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Oiticica, MD PhD
Phone
+551130880299
Email
jeanneramalho@uol.com.br
First Name & Middle Initial & Last Name & Degree
Juliana Anauate, MD
Phone
+5511982921245
Email
juliana.anauate@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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