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Status unknownNCT03295890Updated Sep 28, 2017

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

An interventional study of Dry Needing in Tinnitus, Trigger Point Pain, Myofascial and Somatosensory Disorders, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-28.

Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Tinnitus
  • Trigger Point Pain, Myofascial
  • Somatosensory Disorders

Keywords

  • myofascial trigger point, tinnitus, dry needling
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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,
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Sham comparator
    Sham Needling

    Intervention = Sham Needling

    Procedure: Dry Needing

  • Active comparator
    Active Needling

    Intervention = Active Needling

    Procedure: Dry Needing

Interventions

  • ProcedureDry Needing

    Dry Needling

05

What researchers measure

Primary outcomes

  1. Placebo Dry Needling

    Placebo Needling on trigger points

    Time frame: 4 weeks

Secondary outcomes

  1. Active Dry needling

    Therapeutic needling on trigger points

    Time frame: 4 weeks

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03295890
Lead sponsor
University of Sao Paulo General Hospital
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Jul 29, 2016
Primary completion
Jun 5, 2018 (estimated)
Completion
Jul 29, 2020 (estimated)
Last update
Sep 28, 2017

Study contacts

Jeanne Oiticica, MD PhD
Contact
jeanne.ramalho@uol.com.br
5511974361596
Juliana Aguiar, MD
Contact
juliana.anauate@gmail.com
5511982921245
Ricardo Bento, MD PhD
study chair · University of Sao Paulo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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