Comparison of the effectiveness between transcutaneous electrical nerve stimulation, manual acupuncture, and electroacupuncture on tinnitus: study protocol for a randomized controlled trial

Moon et al. Trials (2018) 19:342 https://doi.org/10.1186/s13063-018-2738-9 STUDY PROTOCOL Open Access Comparison of the effectiveness between transcutaneous electrical nerve stimulation, manual acupuncture, and electroacupuncture on tinnitus: study protocol for a randomized controlled trial Young-Kyun Moon1, Min Hee Kim2 and Hae Jeong Nam1* Abstract Background: Transcutaneous electrical nerve stimulation (TENS) involves a neuromodulatory effect using electrical stimulation and has been widely used due to its safety and convenience. It has been used for treating tinnitus for decades. Acupuncture has also been used for tinnitus and several research studies have shown that acupuncture can improve a certain kind of tinnitus by stimulating the somatosensory system. Moreover, several studies have shown the efficacy of electroacupuncture, which is a combination of acupuncture and electrical stimulation, for tinnitus. However, the comparative effectiveness of TENS, manual acupuncture, and electroacupuncture for the treatment of tinnitus has not been determined previously. Herein, we design a randomized, non-blind clinical trial to investigate and compare the effects and safety of TENS, manual acupuncture, and electroacupuncture for tinnitus. Methods: After screening, 45 patients are randomly assigned to three groups: (1) patients in the TENS group are treated at four sites (tender points of masseter and the sternocleidomastoid muscle, in front of tragus, and mastoid process); (2) the manual acupuncture group patients are treated at 11 acupoints (TE21, SI19, GB2, TE22, ST7, TE17, GB20 of tinnitus affected side, and GB20, TE05, KI3 of both sides); (3) electroacupuncture group patients are treated by using acupuncture as in the manual acupuncture group and electrical stimulation at TE21, SI19, TE17, and GB20. Patients are treated for ten sessions, twice a week. The primary outcome measurement is the change of Tinnitus Handicap Inventory (THI) score between visit 1 and visit 10. The secondary outcome measurements are the response rate of THI, change in visual analogue scale associated with the loudness and annoyance of tinnitus, pure-tone audiometry and speech discrimination, and changes in parameters of heart rate variability. Discussion: The purpose of this study is to compare the effect of TENS, manual acupuncture, and electroacupuncture in the auricular area on tinnitus. If the specific treatment shows a significant effect compared to other treatments, it could have potential for use in clinical practice as a primary treatment. Trial registration: Clinical Research Information Service (CRIS), KCT0002117. Registered October 21, 2016. Retrospectively registered. Keywords: Tinnitus, Transcutaneous nerve stimulation (TENS), Electroacupuncture, Manual acupuncture * Correspondence: 1 Department of Ophthalmology and Otolaryngology of Korean Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Moon et al. Trials (2018) 19:342 Background Tinnitus is a symptom in which some kind of sound is recognized in the absence of external auditory stimulation. The results of many studies indicate that 5 to 15% of the population show symptoms of tinnitus that are not alleviated by treatment. Moreover, 1 to 3% of the population with tinnitus have mental stress, sleep disorders, and reduced work productivity [1]. Treatment to relieve tinnitus symptoms include cognitive behavioral therapy [2], counseling treatment [3], tinnitus retraining therapy (TRT) [4], hearing aids [5], cochlear implant therapy [6], drug therapy [7], and various types of invasive or non-invasive electrical stimulation, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and transcutaneous electrical nerve stimulation (TENS) [8]. Because there is no recommended medicine for tinnitus [9], physiotherapy is considered to have a sufficient effect, despite the lack of evidence for its long-lasting effect on tinnitus [10–12]. Among the modalities of physiotherapy, TENS is one of the most safe, non-invasive, and effective treatments [8]. Therefore, TENS has been used for treating tinnitus for decades [13–15]. In many cases of TENS treatment for tinnitus, the C2 dermatome or the vagus nerve around the ear is treated [8, 16–18]. In contrast, systemic and periauricular acupoints have been determined as the manual acupuncture (MA) and electroacupuncture (EA) treatment sites for tinnitus, according to the meridian system theory in TCM [19]. TENS is a relatively simple procedure by which electrical stimulation is applied using a quantified machine, whereas MA and EA are relatively inaccessible for those unfamiliar with TCM theory since the practitioner’s knowledge and technique are needed. However, the similarity among TENS, MA, and EA treatments for tinnitus is that the targeted treatment area is around the ear. Identification of a significant difference between the effects of physical therapy administered with TENS and MA and EA treatments in this study would help to determine the most appropriate physiotherapy stimuli and strengths for the treatment of tinnitus. Several studies have compared the efficacy of TENS [15, 16], MA [12, 20], and EA [21] with a placebo-controlled group; in addition, one study has compared the effectiveness between MA and EA treatment for tinnitus [22]. However, trials that compared the effect of TENS and MA or TENS and EA have not been conducted. Moreover, no study has compared the effects of TENS, MA, and EA on tinnitus at the same time. In this trial, participants are treated with periauricular TENS, systemic and periauricular MA according to the meridian system theory in TCM, and EA with MA plus periauricular electro-stimulation. From the results of this study, we will determine which treatment is more effective for tinnitus between MA and Page 2 of 8 EA with MA plus periauricular electro-stimulation. Then, the efficacy of TENS, MA, and EA will be compared to determine the most effective treatment for tinnitus. The results of this study are expected to help in determining the first-line physiotherapy for tinnitus. Methods/design Study design This article includes all components as described in the SPIRIT checklist (Additional file 1). This prospective, ra (...truncated)