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
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus Trigger Point Pain, Myofascial Somatosensory Disorders||Procedure: Dry Needing||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
Sham Comparator: Sham Needling
Intervention = Sham Needling
Procedure: Dry Needing
Active Comparator: Active Needling
Intervention = Active Needling
Procedure: Dry Needing
- Placebo Dry Needling [ Time Frame: 4 weeks ]Placebo Needling on trigger points
- Active Dry needling [ Time Frame: 4 weeks ]Therapeutic needling on trigger points
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
|Contact: Jeanne Oiticica, MD PhDemail@example.com|
|Contact: Juliana Aguiar, MDfirstname.lastname@example.org|
|University of Sao Paulo||Recruiting|
|São Paulo, Sao Paulo, Brazil, 05403000|
|Contact: Jeanne Oiticica, MD PhD +551130880299 email@example.com|
|Contact: Juliana Anauate, MD +5511982921245 firstname.lastname@example.org|
|Study Chair:||Ricardo Bento, MD PhD||University of Sao Paulo|