UnknownNot Applicable

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

Brazil30 participantsStarted 2016-07-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Placebo Dry Needling

Timeframe: 4 weeks

Trial details

NCT IDNCT03295890

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-05

Contact for this trial

Jeanne Oiticica, MD PhD

5511974361596 jeanne.ramalho@uol.com.br

View on ClinicalTrials.gov More Tinnitus trials