Dataset Information

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

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.

SUBMITTER: Moon YK

PROVIDER: S-EPMC6020312 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Moon Young-Kyun YK Kim Min Hee MH Nam Hae Jeong HJ

Trials 20180627 1

<h4>Background</h4>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, w ...[more]

PMID: 29945669

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Project description:Introduction Tinnitus can become a strong stressor for some individuals, leading to imbalance of the autonomous nervous system with reduction of parasympathetic activity. It can manifest itself as sleep disturbances, anxiety and even depression. This condition can be reversed by bioelectrical vagal nerve stimulation (VNS). Conventional invasive VNS is an approved treatment for epilepsy and depression. Transcutaneous VNS (taVNS) stimulating the auricular branch of the vagus nerve has been shown to activate the vagal pathways similarly as an implanted VNS. Therefore, taVNS might also be a therapeutic alternative in health conditions such as tinnitus-related mental stress (TRMS). This retrospective study in 171 TRMS patients reports the clinical features, psychophysiological characteristics, and results of the heart rate variability (HRV) tests before and after test-taVNS. This study also reports the therapy outcomes of 113 TRMS patients treated with taVNS, in combination with standard tinnitus therapy. Methods Diagnostic tinnitus and hearing profiles were defined. To detect possible cardiac adverse effects, test-taVNS with heart rate monitoring as well as pre- and post-stimulation HRV tests were performed. Daily taVNS home therapy was prescribed thereafter. To assess therapeutic usefulness of taVNS, 1-year follow-up outcome was studied. Results of HRV tests were retrospectively analyzed and correlated to diagnostic data. Results The large majority of patients with TRMS suffer from associated symptoms such as sleep disturbances and anxiety. Baseline HRV data showed that more than three quarters of the 171 patients had increased sympathetic activity before test-taVNS. Test-taVNS shifted mean values of different HRV parameters toward increased parasympathetic activity in about 80% of patients. Test-taVNS did not cause any cardiac or other side effects. No significant adverse effects were reported in follow-up questionnaires. Conclusion TRMS is an example of a stress condition in which patients may benefit from taVNS. As revealed by HRV, test-taVNS improved parasympathetic function, most efficiently in patients with a low starting HRV level. Our tinnitus treatment program, including taVNS, effectively alleviated tinnitus stress and handicap. For wider clinical use, there is a great need for more knowledge about the optimal methodology and parameters of taVNS.

Project description:AimTo explore the effectiveness of acupuncture transcutaneous electrical nerve stimulation (Acu-TENS), a non-invasive modality in reduction of rectal discomfort during barostat-induced rectal distension.MethodsForty healthy subjects were randomized to receive 45 min of either Acu-TENS or placebo-TENS (no electrical output) over acupuncture points Hegu (large-intestine 4), Neiguan (pericardium 6) and Zusanli (stomach 36). A balloon catheter attached to a dual-drive barostat machine was then inserted into the subjects' rectum. A step-wise (4 mmHg) increase in balloon pressure was induced until maximal tolerable or 48 mmHg. Visual analogue scale and a 5-point subjective discomfort scale (no perception, first perception of distension, urge to defecate, discomfort/pain and extreme pain) were used to assess rectal discomfort at each distension pressure. Blood beta-endorphin levels were measured before, immediately after intervention, at 24 mmHg and at maximal tolerable distension pressure.ResultsThere was no difference in the demographic data and baseline plasma beta-endorphin levels between the two groups. Perception threshold levels were higher in the Acu-TENS group when compared to the placebo group, but the difference reached statistical significance only at the sensations "urge to defecate" and "pain". The distension pressures recorded at the "urge to defecate" sensation for the Acu-TENS and placebo-TENS groups were 28.0 ± 4.5 mmHg and 24.6 ± 5.7 mmHg, respectively (P = 0.043); and the pressures recorded for the "pain" sensation for these two groups were 36.0 ± 4.2 mmHg and 30.5 ± 4.3 mmHg respectively (P = 0.002). Compared to the placebo group, a higher number of participants in the Acu-TENS group tolerated higher distension pressures (> 40 mmHg) (65% in Acu-TENS vs 25% in placebo, P = 0.02). The plasma beta-endorphin levels of the Acu-TENS group were significantly higher than that of the placebo group at barostat inflation pressure of 24 mmHg (1.31 ± 0.40 ng/mL vs 1.04 ± 0.43 ng/mL, P = 0.044) and at maximal inflation pressure (1.46 ± 0.53 ng/mL vs 0.95 ± 0.38 ng/mL, P = 0.003).ConclusionAcu-TENS reduced rectal discomfort during barostat-induced rectal distension and concurrently associated with a rise in beta-endorphin level.

Project description:Background: Xerostomia occurs in the majority of patients undergoing chemoradiation therapy for head and neck cancer (HNC). Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) treatment has been studied as an encouraging modality to improve salivary function and related symptoms. The purpose of this study was to compare ALTENS treatment by using a four-times weekly schedule for 6 weeks versus a twice-weekly schedule for 12 weeks with a validated xerostomia scale at 15 months from the start of ALTENS treatment. Materials and Methods: This single-center randomized study was conducted in 30 patients treated with radiotherapy with or without chemotherapy for HNC between 2014 and 2017, who had at least grade 1 or 2 symptomatic dry mouth (xerostomia) according to CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0). These patients were randomly assigned to receive ALTENS four-times weekly for 6 weeks or two-times weekly for 12 weeks. The University of Michigan 15-item Xerostomia-related Quality of Life Scale (XeQoLS) was administered at 6, 9, 15, and 21 months from the start of ALTENS treatment. A random-effects generalized linear model was used to model the overall XeQoLS score at the 15-month endpoint; adjusted for a random time effect, a fixed treatment arm, and interaction of time and treatment. Comparison between arms was based on a 0.05 nominal significance level. Results: XeQoLS decreased for all patients (although not statistically for each arm) from a mean of 22 and 21 at baseline (in the four times per week and twice weekly arms) to 12 in both arms at 15 months, with no difference between arms (p = 0.68). There were no attributable grade 1-3 adverse events. Arms were balanced for age, gender, race, and baseline xerostomia. Conclusions: This study demonstrates that both ALTENS regimens are safe, well tolerated, and appear to be equally effective. We now routinely make ALTENS units available for home use.

Dataset Information

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

Background

Methods

Discussion

Trial registration

Publications

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

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