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

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ClinicalTrials.gov Identifier: NCT03295890
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE September 22, 2017
First Posted Date  ICMJE September 28, 2017
Last Update Posted Date September 28, 2017
Actual Study Start Date  ICMJE July 29, 2016
Estimated Primary Completion Date June 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
Placebo Dry Needling [ Time Frame: 4 weeks ]
Placebo Needling on trigger points
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
Active Dry needling [ Time Frame: 4 weeks ]
Therapeutic needling on trigger points
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dry Needling on the Treatment of Chronic Somatosensory Tinnitus: An Open Pilot Study
Official Title  ICMJE Dry Needling on the Treatment of Chronic Somatosensory Tinnitus: An Open Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Tinnitus
  • Trigger Point Pain, Myofascial
  • Somatosensory Disorders
Intervention  ICMJE Procedure: Dry Needing
Dry Needling
Study Arms  ICMJE
  • Sham Comparator: Sham Needling
    Intervention = Sham Needling
    Intervention: Procedure: Dry Needing
  • Active Comparator: Active Needling
    Intervention = Active Needling
    Intervention: Procedure: Dry Needing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 29, 2020
Estimated Primary Completion Date June 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jeanne Oiticica, MD PhD 5511974361596 jeanne.ramalho@uol.com.br
Contact: Juliana Aguiar, MD 5511982921245 juliana.anauate@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03295890
Other Study ID Numbers  ICMJE USaoPauloGHGZ
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ricardo Bento, MD PhD University of Sao Paulo
PRS Account University of Sao Paulo General Hospital
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP