1. Objective
- The purpose of this study is to compare the effects of transcutaneous electric nerve stimulation (TENS), manual acupuncture (MA), and electroacupuncture (EA) on tinnitus.

2. Background
- Electrical stimulation treatments that have been utilized to treat tinnitus are TENS, TMS(transcranial magnetic stimulation), tDCS(transcranial direct current stimulation), subcutaneous occipital nerve stimulation, DBS(Deep Brain Stimulation), and EA.
Non-invasive neuromodulations are TENS, TMS, tDCS, and so on. Due to the cost-effectiveness and safety of the treatment, TENS has been used for treating tinnitus since the 1970s. In studies that have utilized TENS in the treatment of tinnitus, electrode attachment sites were varied by temporomandibular joint (TMJ), pinna, tragus, and C2 dermatome (mastoid process). The response rate of patients treated with TENS varied greatly from 17.9% to 82% depending on the study. Among them, TENS on C2 dermatome is known to exhibit an inhibitory effect on tinnitus by increasing the effect of dorsal cochlear nucleus (DCN) in the central auditory nervous system.
 Acupuncture is a type of traditional Korean Medicne treatment that has been used since long ago for treating tinnitus. Although its mechanism is complex, it is believed that acupuncture improves certain kind of tinnitus by stimulating somatosensory system.
 EA is a treatment using acupuncture needles with electrical stimulation. For this reason, it is considered to have both characteristics of manual acupuncture and electrical stimulation therapy.
 Wang et al. reported a significant improvement of subjective tinnitus symptom in the EA group compared to the manual acupuncture group shortly after 6 weeks of treatment. However, the furthur study is necessay since the studies on the effects of EA for tinnitus are scarce.
 This study was designed to compare the effectiveness of TENS, EA, and acupuncture. The results of this study will help to determine the first line treatment of tinnitus.

3. Clinical research plan
- 45 patients who meet the inclusion criteria and none of exclusion criteria after screening are randomly assigned to TENS group, EA group, and MA group, respectively by 15. Afterwards, patients will be treated twice a week for five weeks. A follow-up will be conducted four weeks after the end of treatment.
Subjective tinnitus loudness and annoyance perception wil be graded using VAS every visit.  THI, HRV(Heart Rate Variability), skin conductance and audiometric test will be performed at visit1, 5, 10, and follow-up session. 
 TENS treatment will be performed by using SSP (Silver Spike Point, low frequency electrotherapeutic device – Pointron 801). A pair of electrodes are attached to the sternomastoid and lower mastoid process (C2) on the affected side, and another pair of electrodes was placed to a trigger point of masseter muscle and temporomandibular joint in front of the ear. Afterwards, 30Hz electrical stimulation was applied for 20 minutes. 
 Patients who are assigned as manual acupuncture(MA) group and electroacupuncture(EA) group will receive acupuncture at 11 acupoints(TE21, SI19, GB2, TE22, ST7, TE17, GB20 of affected side, and GB20, TE05, KI3 of both sides) using sterilized disposable stainless needle of 0.25mm diameter and 40mm in length. Needling depth is approximately 5~10mm, it might depend on the differences of anatomical structure and individual characteristics of acupoints. Neddles will be retained for 20 minutes.
 EA group pateints will receive electrical stimulation at TE21, SI19 and TE17, GB20 of afftected side of tinnitus at mixed frequency 30/90Hz interval 3sec after the needles are inserted into acupoints.
 Both The stimulation intensity will be adjusted to relatively high but neither unpleasant nor painful level.

Treatment

 TENS treatment will be performed by using SSP (Silver Spike Point, low frequency electrotherapeutic device – Pointron 801). A pair of electrodes are attached to the sternomastoid and lower mastoid process (C2) on the affected side, and another pair of electrodes was placed to a trigger point of masseter muscle and temporomandibular joint in front of the ear. Afterwards, 30Hz electrical stimulation was applied for 20 minutes. The stimulation will be adjusted as relatively high intensity but neither unpleasant nor painful.
 Patients who are assigned as manual acupuncture(MA) group and electroacupuncture(EA) group will receive acupuncture at 11 acupoints(TE21, SI19, GB2, TE22, ST7, TE17, GB20 of affected side, and GB20, TE05, KI3 of both sides) using sterilized disposable stainless needle of 0.25mm diameter and 40mm in length. Needling depth will be approximately 5~10mm, depending on the differences of anatomical structure and individual characteristics of acupoints. It is advisable to retain the needles for 20 minutes.
 In the case of EA group, after the needles are inserted into acupoints metioned above, will receive electrical stimulation at TE21, SI19 and TE17, GB20 of afftected side of tinnitus at mixed frequency 30/90Hz interval 3sec. Stimulation intensity needs to be relatively high but neither unpleasant nor painful.

Arm Label

Target Number of Participant

Arm Type

Arm Description

 TENS treatment will be performed by using SSP (Silver Spike Point, low frequency electrotherapeutic device – Pointron 801). A pair of electrodes are attached to the sternomastoid and lower mastoid process (C2) on the affected side, and another pair of electrodes was placed to a trigger point of masseter muscle and temporomandibular joint in front of the ear. Afterwards, 30Hz electrical stimulation was applied for 20 minutes. The stimulus intensity needed to be relatively high but neither unpleasant nor painful.

Arm Label

Target Number of Participant

Arm Type

Arm Description

 Patients who are assigned as manual acupuncture(MA) group and electroacupuncture(EA) group will receive acupuncture at 11 acupoints(TE21, SI19, GB2, TE22, ST7, TE17, GB20 of affected side, and GB20, TE05, KI3 of both sides) using sterilized disposable stainless needle of 0.25mm diameter and 40mm in length. Needling depth will be approximately 5~10mm, depending on the differences of anatomical structure and individual characteristics of acupoints. Acupuncture needles will be retained for 20 minutes.

Arm Label

Target Number of Participant

Arm Type

Arm Description

After the needles are inserted into acupoints metioned above, will receive electrical stimulation at TE21, SI19 and TE17, GB20 of afftected side of tinnitus at mixed frequency 30/90Hz interval 3sec. Stimulation intensity will be relatively high but neither unpleasant nor painful.

Gender

Age

Description

1. Men and women aged 20 to 75
2. Patients with persistent tinnitus for 6 months or more
3. Patients who have agreed not to receive any type of medical treatment from another hospital to treat tinnitus
4.  Patients who voluntarily choose to participate in the study  

1. Patients who have undergone tinnitus treatment such as acupuncture and TENS within three months
2. Patients who have medicines and surgical procedures due to cardiac disorder, or patients with pacemaker implants 
3. Patients with disease—meniere’s disease, tympanitis, and otosclerosis—that certainly can cause tinnitus
4. Patients who have metal allergies and needle phobia
5. Patients who take psychoactive drugs to treat tinnitus symptoms
6. Patients who gave birth within six months, or patients who are currently pregnant or breastfeeding   
7. Patients who are unable to perform evaluation test and complete the questionnaire 
8. Patients who are considered unsuitable for the study based on the opinion of the investigators

respond rate of Tinnitus Handicap Inventory(THI) - evaluated as a responder if THI score improved more than 10 points

Baseline, visit 5, end of treatments(visit 10), follow-up visit(visit11, 4 weeks after the end of treatment sessions)

THI score

Baseline, visit 5, end of treatments(visit 10), follow-up visit(visit11, 4 weeks after the end of treatment sessions)

VAS(loudness, annoyance)

VAS : every visit (before and after the treatment in the treatment visits)

Pure tone audiometry(PTA)

Baseline, visit 5, end of treatments(visit 10), follow-up visit(visit11, 4 weeks after the end of treatment sessions)

Speech Discrimination(SD)

Baseline, visit 5, end of treatments(visit 10), follow-up visit(visit11, 4 weeks after the end of treatment sessions)

skin conductance

Baseline, visit 5, end of treatments(visit 10)

Heart Rate Variability(HRV)

Baseline, visit 5, end of treatments(visit 10)