Acupuncture as a Treatment for Tinnitus

NCT02290015 | Completed DMC

• 1 other identifier: FAPESP-2010/14804-6
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Tinnitus

Keywords

Single Photon Emission Computed Tomography; Acupuncture

Outcome Measures

Primary Outcomes (1)

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

  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)

  The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)

• Visual Analog Scale (VAS)

  The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)

• Hamilton Anxiety Scale (HAS)

  The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)

• Beck Depression Inventory (BDI)

  The scale was performed seven days before (baseline) and seven days after acupuncture treatment (up to six weeks)

Study Arms (2)

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.

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.

Other: Acupuncture

Interventions

Acupuncture OTHER

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).

sham acupuncture; true acupuncture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Tinnitus

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Andrea P Jackowski, PhD

  Federal University of São Paulo UNIFESP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 13, 2014
• Study Start: August 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2014
• Last Updated: November 13, 2014

Record last verified: 2014-11