TinnitusNCT03295890
Dry Needling on the Treatment of Chronic Somatosensory Tinnitus: An Open Pilot Study
A study testing Dry Needing in people with Tinnitus and Trigger Point Pain, Myofascial, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Trigger Point Pain, Myofascial, Somatosensory Disorders
- What is being tested?
- Dry Needing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Jul 2016to 29 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo, São Paulo, 05403000
Jeanne Oiticica, MD PhD, +551130880299, jeanneramalho@uol.com.br
Juliana Anauate, MD, +5511982921245, juliana.anauate@gmail.com
About this study
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:
- 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.
- Being tested
- Dry Needing
- Keywords
- myofascial trigger point, tinnitus, dry needling
- Medical subject headings
- Tinnitus, Myofascial Pain Syndromes, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedingProcedure or surgery
Dry Needling
| Study group | Role | What they receive |
|---|---|---|
| Sham Needling | Sham comparator | Intervention = Sham Needling Receives: Procedure: Dry Needing |
| Active Needling | Active comparator | Intervention = Active Needling Receives: Procedure: Dry Needing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo Dry Needling
Placebo Needling on trigger points
Measured: 4 weeks
Secondary outcomes (1)
Active Dry needling
Therapeutic needling on trigger points
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start29 Jul 2016
- Primary completion5 Jun 2018 (estimated)
- Study completion29 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Bento, MD PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295890
- Sponsor's protocol ID
- USaoPauloGHGZ
- Status last verified
- Sep 2017
- First submitted
- 22 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling on the Treatment of Chronic Somatosensory Tinnitus: An Open Pilot Study
- ClinicalTrials.gov ID
- NCT03295890
- Acronym / sponsor ID
- USaoPauloGHGZ
- Keywords
- myofascial trigger point, tinnitus, dry needling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 29 Jul 2016 (actual)
- Primary completion
- 5 Jun 2018 (estimated)
- Study completion
- 29 Jul 2020 (estimated)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Needling | Sham comparator | Procedure: Dry NeedingIntervention = Sham Needling |
| Active Needling | Active comparator | Procedure: Dry NeedingIntervention = Active Needling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedingDry Needling | Procedure or surgery | Active Needling, Sham Needling |
Primary outcome
Placebo Dry Needling
Time frame: 4 weeks
Placebo Needling on trigger points
1 secondary outcome
Active Dry needling
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Bento, MD PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needing in people with Tinnitus and Trigger Point Pain, Myofascial, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeanne Oiticica, MD PhD (5511974361596, jeanne.ramalho@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo Dry Needling (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.