TinnitusNCT02290015
Acupuncture as a Treatment for Tinnitus
A study testing Acupuncture in people with Tinnitus, run by Federal University of São Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Mar 2014
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Effectiveness of Acupuncture as a Treatment for Tinnitus: a Randomized Controlled Trial Using 99mTc-ECD SPECT
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).
Read the 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.
- Conditions
- Tinnitus
- Being tested
- Acupuncture
- Keywords
- Single Photon Emission Computed Tomography; Acupuncture
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| true acupuncture | Experimental | 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. Receives: Other: Acupuncture |
| sham acupuncture | Sham comparator | 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. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ethylcysteinate dimer single-photon emission computer tomography (99mTc-ECD SPECT)
Measured: SPECT exam was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
Secondary outcomes (4)
Tinnitus Handicap Inventory (THI)
Measured: The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
Visual Analog Scale (VAS)
Measured: The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
Hamilton Anxiety Scale (HAS)
Measured: The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
Beck Depression Inventory (BDI)
Measured: The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startAug 2010
- Primary completionSep 2013
- Study completionMar 2014
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Maura Regina Laureano, Federal University of São Paulo
- Investigators
- Andrea P Jackowski, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290015
- Sponsor's protocol ID
- FAPESP-2010/14804-6
- Status last verified
- Nov 2014
- First submitted
- 28 Oct 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture as a Treatment for Tinnitus: a Randomized Controlled Trial Using 99mTc-ECD SPECT
- ClinicalTrials.gov ID
- NCT02290015
- Acronym / sponsor ID
- FAPESP-2010/14804-6
- Conditions
- Tinnitus
- Keywords
- Single Photon Emission Computed Tomography; Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Nov 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| true acupuncture | Experimental | Other: Acupuncture12 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. |
| sham acupuncture | Sham comparator | Other: AcupunctureThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| AcupunctureAll 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). | Other | sham acupuncture, true acupuncture |
Primary outcome
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)
4 secondary outcomes
Tinnitus Handicap Inventory (THI)
Time frame: The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
Visual Analog Scale (VAS)
Time frame: The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
Hamilton Anxiety Scale (HAS)
Time frame: The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
Beck Depression Inventory (BDI)
Time frame: The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
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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.
Andrea P Jackowski, PhD study director
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Tinnitus, run by Federal University of São Paulo.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 13 Nov 2014.