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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

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.

Condition or disease Intervention/treatment Phase
Tinnitus Trigger Point Pain, Myofascial Somatosensory Disorders Procedure: Dry Needing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dry Needling on the Treatment of Chronic Somatosensory Tinnitus: An Open Pilot Study
Actual Study Start Date : July 29, 2016
Estimated Primary Completion Date : June 5, 2018
Estimated Study Completion Date : July 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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




Primary Outcome Measures :
  1. Placebo Dry Needling [ Time Frame: 4 weeks ]
    Placebo Needling on trigger points


Secondary Outcome Measures :
  1. Active Dry needling [ Time Frame: 4 weeks ]
    Therapeutic needling on trigger points



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295890


Contacts
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Contact: Jeanne Oiticica, MD PhD 5511974361596 jeanne.ramalho@uol.com.br
Contact: Juliana Aguiar, MD 5511982921245 juliana.anauate@gmail.com

Locations
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Brazil
University of Sao Paulo Recruiting
São Paulo, Sao Paulo, Brazil, 05403000
Contact: Jeanne Oiticica, MD PhD    +551130880299    jeanneramalho@uol.com.br   
Contact: Juliana Anauate, MD    +5511982921245    juliana.anauate@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Chair: Ricardo Bento, MD PhD University of Sao Paulo

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03295890     History of Changes
Other Study ID Numbers: USaoPauloGHGZ
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Sao Paulo General Hospital:
myofascial trigger point, tinnitus, dry needling

Additional relevant MeSH terms:
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Tinnitus
Myofascial Pain Syndromes
Somatosensory Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases