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Acupuncture as a Treatment for Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Single Photon Emission Computed Tomography; Acupuncture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients who met all the following conditions were considered for inclusion:

  • 18 to 60 years of age
  • Existence of typical conditions of subjective and continuous tinnitus, either unilateral or bilateral, for more than three months
  • Normal hearing sensitivity in the conventional audiometric range (up to 25 dB from 250 to 8000 Hz) bilaterally and normal immittance measures (type A curve) in both ears

Exclusion Criteria:

The exclusion criteria were as follows:

  • Objective, acute or intermittent tinnitus
  • History of Ménière's disease
  • Tinnitus induced by cerebellopontine angle tumors, cardiovascular disease, or a serious medical or mental illness
  • History of central nervous system disease
  • Current pregnancy or breast-feeding
  • Patients with a lack of willingness or availability to cooperate were also excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    true acupuncture

    sham acupuncture

    Arm Description

    12 sessions of ACP treatment were performed twice a week. Before ACP was performed, patients were examined based on the diagnostic pattern of TCM. Then, the appropriate acupoints for treatment were selected according to the tinnitus-related syndrome. The experimental group was treated with true ACP (stimulating selected meridian points), and the control group was treated with sham-ACP (stimulating false meridian points). The patients were blinded to the identity of their treatment group. Disposable stainless steel ACP needles (0.25 x 30 mm, Dong Bang Acupuncture, Korea) were used in both groups. Needles were inserted manually at each meridian point, and the retention time was twenty minutes.

    The control group was treated with sham-ACP (stimulating false meridian points). Disposable stainless steel ACP needles (0.25 x 30 mm, Dong Bang Acupuncture, Korea) were used. Needles were inserted manually at each false meridian point, and the retention time was twenty minutes.

    Outcomes

    Primary Outcome Measures

    Ethylcysteinate dimer single-photon emission computer tomography (99mTc-ECD SPECT)

    Secondary Outcome Measures

    Tinnitus Handicap Inventory (THI)
    Visual Analog Scale (VAS)
    Hamilton Anxiety Scale (HAS)
    Beck Depression Inventory (BDI)

    Full Information

    First Posted
    October 28, 2014
    Last Updated
    November 8, 2014
    Sponsor
    Federal University of São Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02290015
    Brief Title
    Acupuncture as a Treatment for Tinnitus
    Official Title
    Effectiveness of Acupuncture as a Treatment for Tinnitus: a Randomized Controlled Trial Using 99mTc-ECD SPECT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This trial was a randomized, single-blinded, sham-controlled study, in which the patients were blinded to treatment assignment. First, all candidates underwent audiological testing of hearing thresholds, tympanometry and stapedius reflex tests. The patients who were selected for the study were interviewed to assess and evaluate their condition and then underwent a detailed physical examination that included a complete otorhinolaryngologic examination and a complete blood test. Then, the subjects were randomized to undergo true or sham ACP. Seven days before (baseline) and seven days after twelve acupuncture (ACP) sessions (up to six weeks), which were performed twice a week, all participants underwent 99mTc-ECD SPECT scanning and completed the Portuguese version of the Tinnitus Handicap Inventory (THI), the Visual Analogue Scale (VAS), Hamilton Anxiety Scale (HAS) and the Beck Depression Inventory (BDI). The purpose of this study was to integrate the neuroscience research findings with the clinical research on tinnitus. Thus, a randomized, single-blinded, placebo-controlled trial was implemented to investigate the effect of ACP as a treatment for tinnitus using ethylcysteine dimer single-photon emission computer tomography (99mTc-ECD SPECT).
    Detailed Description
    Acupuncture (ACP) is frequently used to treat tinnitus, the condition defined as the perception of sound in the absence of an external auditory stimulus. However, no information is available regarding the consequences of ACP on the neural architecture and functionality of the brain in tinnitus patients. The aim of this study was to investigate changes in brain activity using ethylcysteine dimer single-photon emission computer tomography (99mTc-ECD SPECT) in patients with tinnitus and normal hearing who underwent ACP treatment. Methods and Findings: This was a randomized, single-blinded, sham-controlled study. The participants were adults (18-60 years old) with either normal hearing or chronic, idiopathic and continuous (+ 3 months) tinnitus. Fifty-seven (57) subjects were randomized to receive true (n=30) or sham (n=27) ACP, and 99mTc-ECD SPECT exams were performed seven days before (baseline) and seven days after twelve ACP sessions (up to six weeks), which were performed twice a week. Secondary outcomes included changes in the Tinnitus Handicap Inventory (THI), the Visual Analog Scale (VAS), the Hamilton Anxiety Scale (HAS) and the Beck Depression Inventory (BDI). Data regarding imaging outcomes were analyzed with Statistical Parametric Mapping (SPM8) software using a factorial design. For secondary outcomes, regression models were built considering two different analytical paradigms: intention-to-treat (ITT; where multiple imputations were conducted due to loss to follow-up) and complete cases. No significant differences in brain perfusion were observed between patients who underwent true versus sham ACP treatment. However, a significant improvement in THI scores at the end of true ACP treatment was observed for all domains (all p < 0.001), with the exception of the catastrophic field. For the other outcome measurements (VAS, BDI and HAS), no significant differences were observed between groups. The small sample size represents a potential limitation of this study. Conclusions: These findings suggest that ACP may improve the impact of tinnitus on daily life, although additional studies are needed to verify the consequences of ACP on the neural architecture and functionality of the brain in tinnitus patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus
    Keywords
    Single Photon Emission Computed Tomography; Acupuncture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    57 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    true acupuncture
    Arm Type
    Experimental
    Arm Description
    12 sessions of ACP treatment were performed twice a week. Before ACP was performed, patients were examined based on the diagnostic pattern of TCM. Then, the appropriate acupoints for treatment were selected according to the tinnitus-related syndrome. The experimental group was treated with true ACP (stimulating selected meridian points), and the control group was treated with sham-ACP (stimulating false meridian points). The patients were blinded to the identity of their treatment group. Disposable stainless steel ACP needles (0.25 x 30 mm, Dong Bang Acupuncture, Korea) were used in both groups. Needles were inserted manually at each meridian point, and the retention time was twenty minutes.
    Arm Title
    sham acupuncture
    Arm Type
    Sham Comparator
    Arm Description
    The control group was treated with sham-ACP (stimulating false meridian points). Disposable stainless steel ACP needles (0.25 x 30 mm, Dong Bang Acupuncture, Korea) were used. Needles were inserted manually at each false meridian point, and the retention time was twenty minutes.
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture
    Intervention Description
    All treatments were performed by the same acupuncturist, who is a medical doctor with more than eight years of clinical and research experience in ACP for tinnitus. Acupoints described as being effective for tinnitus were selected according to TCM theory. Basic points that are manipulated in ACP include GV 20 (Baihui), TE 17 (Yifeng), GB 8 (Shuaigu), SI 19 (Tinggong), GB 2 (Tinghui), TE 21 (Ermen), VC 23 (Lianquan), GB 20 (Fengchi), TE 2 (Yemen), TE 5 (Waiguan), SI 2 (Qiangu), GB 43 (Xiaxi) and GB 41 (Zulinqi). However, several secondary (accessory) acupoints were also added according to TCM and the etiological diagnosis of tinnitus: GV 4 (Mingmen), KI 3 (Taixi), BL 23 (Shenshu), BL 19 (Danshu), BL 18 (Ganshu) and CV 4 (Guanyuan).
    Primary Outcome Measure Information:
    Title
    Ethylcysteinate dimer single-photon emission computer tomography (99mTc-ECD SPECT)
    Time Frame
    SPECT exam was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
    Secondary Outcome Measure Information:
    Title
    Tinnitus Handicap Inventory (THI)
    Time Frame
    The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
    Title
    Visual Analog Scale (VAS)
    Time Frame
    The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
    Title
    Hamilton Anxiety Scale (HAS)
    Time Frame
    The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
    Title
    Beck Depression Inventory (BDI)
    Time Frame
    The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who met all the following conditions were considered for inclusion: 18 to 60 years of age Existence of typical conditions of subjective and continuous tinnitus, either unilateral or bilateral, for more than three months Normal hearing sensitivity in the conventional audiometric range (up to 25 dB from 250 to 8000 Hz) bilaterally and normal immittance measures (type A curve) in both ears Exclusion Criteria: The exclusion criteria were as follows: Objective, acute or intermittent tinnitus History of Ménière's disease Tinnitus induced by cerebellopontine angle tumors, cardiovascular disease, or a serious medical or mental illness History of central nervous system disease Current pregnancy or breast-feeding Patients with a lack of willingness or availability to cooperate were also excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrea P Jackowski, PhD
    Organizational Affiliation
    Federal University of São Paulo UNIFESP
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Acupuncture as a Treatment for Tinnitus

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