AbstractObjectivesThis study aimed to review and synthesize randomized controlled trials (RCTs) of acupotomy on tinnitus to clarify its therapeutic potential and provide a foundation for future research.
MethodsA systematic literature search was conducted in seven databases (KCI, OASIS, RISS, KISS, Embase, Cochrane Library, and CNKI) for studies published between 2016 and August 2025. Eligible studies were RCTs employing acupotomy as an intervention for tinnitus. Study characteristics, treatment protocols, outcome measures, and methodological quality were analyzed. The risk of bias was assessed using the Cochrane Risk of Bias 2.0 tool.
ResultsSix RCTs were included, most of which investigated cervicogenic tinnitus (n=4). In all trials, acupotomy was applied as a concomitant intervention. Frequently selected treatment points included tenderness nodules, the inferior nuchal line, and the spinous process of second cervical vertebrae. Intervention groups demonstrated higher effective rates and greater improvements in tinnitus questionnaires compared with control groups. Improvements in blood flow velocity were observed in some studies, although results were inconsistent. The methodological quality of included studies was generally rated as high risk due to insufficient randomization concealment, lack of blinding, and absence of protocol registration.
IntroductionTinnitus is defined as an abnormal auditory perception of sound in the absence of external stimulation. It is a common condition with a prevalence of 10–15%. Patients who experience tinnitus often describe the sound as resembling a cicada, wind, ringing bell, or high-pitched tone. Tinnitus can be classified as objective tinnitus, which involves an actual sound produced by a physical source and subjective tinnitus, which has no specific physical cause within the body. Rather than being caused by a single factor, tinnitus is considered a multifactorial neurological symptom in which the peripheral and central auditory systems interact, while non-auditory factors (e.g., temporomandibular joint, cervical spine, emotional state, and autonomic nerves) also play a complex role. Traditionally, tinnitus has been viewed primarily as a disorder of the otology; however, recent approaches emphasize its association with dysfunctions of the nervous system1–3).
According to a Delphi study conducted by the Korean Tinnitus Study Group, treatments such as tinnitus retraining therapy, cognitive behavioral therapy, hearing aids, and physical therapy targeting the cervical spine or temporomandibular joint are commonly recommended4). In the field of Korean medicine, reviews of treatments such as acupuncture and herbal medicine have also been reported5,6).
Acupotomy, a treatment that combines acupuncture with the use of a scalpel, provides the dual benefits of acupuncture and minimally invasive surgery. Recent analyses of acupotomy research indicate that this therapy treatment primarily focuses on musculoskeletal disorder, with relatively few studies addressing non-musculoskeletal conditions7–8). To date, no review of acupotomy for tinnitus has been reported. Therefore, this study aims to review and synthesize recent clinical studies on acupotomy for tinnitus to clarify its therapeutic potential and provide a foundation for future randomized controlled trials (RCTs) and systematic reviews.
Method1. Search strategyA literature search was conducted on September 17, 2025, covering studies published from 2016 to August 2025. To capture and reflect recent research trends, the search focused on the past ten years. Conference and thesis publications were included and only articles published in peer-reviewed. A total of seven databases were used to search including Korea Citation Index, Oriental Medicine Advanced Searching Integrated System, Research Information Sharing Service, Korean Studies Information Service System, Embase, Cochrane Library, and China National Knowledge Infrastructure. The primary search terms were “Acupotomy,” “Miniscalpel needle,” “Needle knife,” and “Tinnitus.” Search expressions were adapted as appropriate for each language and database. Detailed search strategies are provided in Appendix 1.
2. Data analysisWe analyzed study characteristics (diagnosis, sample size, age, symptom duration, intervention, and control group treatment); acupotomy treatment characteristics (treatment point, needle specification, depth, number, frequency, and treatment period); and outcome measures and results.
3. Assessment of qualityThe Cochrane Risk of Bias (RoB) tool 2.09) was used to evaluate the methodological quality of the include studies. This tool assesses the randomization process, deviation from intended interventions, missing outcome data, measurement of outcomes, and selection of reported results. Two researchers independently applied the tool, and any discrepancies between reviewers were addressed and resolved through consensus-based discussion.
Result1. Study selectionWe included all studies that investigated the use of acupotomy for tinnitus. A total of 45 studies were identified through database searches, of which 16 duplicates were excluded. After screening titles and abstracts, 5 non–Korean medicine studies and 16 non–RCTs were excluded. Following full-text review, one study that was not an RCT and one that did not include tinnitus–related outcome measures were excluded. Consequently, six studies were included in the final analysis (Fig. 1).
2. Assessment of risk of biasThe six included studies10–15) were evaluated using the RoB 2.0 tool and the results are visually summarized in Fig. 2.
5) Bias in selection of the reported resultExcept for one study11), no protocol information was provided. Accordingly, the risk of bias was judged as “some concerns” or “high”, depending on whether multiple measures were used within the same outcome domain. Three studies10,11,14) were judged as having “high risk” because they used multiple outcome measures, whereas the remaining studies12,13,15), which employed single outcomes were judged as having “some concerns”.
3. Study characteristicsIn the analysis of study characteristics, the following variables were included: diagnosis, sample size, age, symptom duration, intervention, and control group treatment (Table 1).
1) DiagnosisOf the six studies, four10,12,13,15) focused on cervical tinnitus, one11) investigated sudden hearing loss with concomitant tinnitus of the qi stagnation and blood stasis type, and one14) examined neurological tinnitus of the damp-heat type. Overall, acupotomy was primarily applied for cervical tinnitus.
2) Intervention and control group treatmentIn all six studies, acupotomy was used as a concomitant therapy rather than as a standalone intervention. In three studies10,11,15), acupotomy was added to the same treatment administered to the control group. Specifically, Bao et al.10) compared acupotomy plus warm acupuncture with warm acupuncture alone, He et al.11) compared acupotomy plus drug therapy (oral prednisone acetate, esomeprazole, mecobalamin and ginkgo biloba extract injection) with drug therapy alone, and Jin et al.15) compared acupotomy plus stellate ganglion block with stellate ganglion block alone.
In the remaining three studies12–14), acupotomy was combined with another therapy and compared with a different conventional treatment. Jin et al.13) evaluated acupotomy combined with cervical manipulation versus acupuncture, Guo12) evaluated acupotomy plus cervical manipulation versus electroacupuncture, and Fang et al.14) evaluated acupotomy plus herbal formula therapy (Qing’er decoction) versus conventional drug therapy (oral flunarizine hydrochloride and mecobalamin).
4. Acupotomy treatmentIn the analysis of acupotomy treatment, the following variables were included: treatment points, needle specifications, number and methods of acupotomy technique, depth, number, frequency, and treatment period (Table 2, 3).
1) Acupotomy treatment pointsIn all included studies, acupotomy was applied to the muscles or structural region of the head and neck. Four studies10,12–14) specifically targeted tender areas or painful nodules as the primary treatment points. The region around the inferior nuchal line was selected in five studies10–13,15) (among those that explicitly reported anatomical sites).
The transverse process was used in four studies10,12,13,15), most frequently at the first cervical vertebra (C1) in three studies12,13,15), followed by C2 and C3 in two studies each10,12), and C4–6 in one study10). The spinous processes were also targeted in four studies11–13,15), with C2 being the most frequently selected site in four studies11–13,15), C3 in one study12) and C7 in one study11).
Among unique applications, Guo et al.10) included the acupuncture point SI19, making it the only study that employed a traditional acupuncture point. Additionally, Fang et al.14) used the vertigo and auditory zones on the scalp, representing the only instance in which a scalp acupuncture site was incorporated.
2) Acupotomy needle specificationsFive of the included studies described the specifications of the disposable acupotomy instruments. Bao et al.10) reported needles measuring 0.4 mm in diameter and 30 in length and 0.6 × 50 mm, whereas He et al.11) used a 0.4 × 40 mm needle. Guo12) employed a 0.35 × 25 mm needle, and Jin et al.13) used a similar 0.40 × 25 mm device. In contrast, Jin et al.15) adopted a larger 0.6 mm diameter needle (type I, No. 4). Fang et al.14) were the only authors who did not provide detailed information about the needle specifications.
3) Treatment protocolThe treatment protocols varied among the included studies (Table 3). Bao et al.10) applied acupotomy once weekly for three weeks, totaling three sessions. He et al.11) performed acupotomy every three days for a total of four sessions over ten days. Guo12) also administered acupotomy every three days, for five sessions within a 15-day period. Jin et al.13) performed acupotomy every other day, including a two-day rest after every five treatments, for a total of ten sessions over three weeks. Fang et al.14) conducted the longest treatment course, conducting twelve weekly sessions over three months. Jin et al.15) carried out four weekly sessions over a four-week period.
Overall, the number of acupotomy sessions ranged from three to twelve, the frequency from every other day to once weekly, and the treatment duration from ten days to three months.
5. Outcome measurements and resultsIn the analysis of outcome measurements and results, the following variables were included: outcome measures and results of included studies. (Table 4).
1) Outcome measurementIn the six included studies, the outcome measures were heterogeneous but could be grouped into four domains. First, global efficacy indicators were used in all studies, primarily measured through the effective rate. Second, subjective tinnitus questionnaires were applied in three studies: one study10) used Tinnitus Handicap Inventory (THI) and two studies11,14) used Tinnitus Evaluation Questionnaire in China (TEQ) as the outcome measure. Third, physiological parameters were assessed in three studies: all three studies used transcranial Doppler ultrasonography (TCD) to evaluate blood flow velocity. Two studies10,15) evaluated both the vertebral artery velocity (VAV) and the basilar artery velocity (BAV), whereas one study12) evaluated only the BAV. Fourth, associated symptoms were assessed in one study. Bao et al.10) evaluated changes in cervical symptoms using the Northwick Park neck pain questionnaire (NPQ).
2) Overview of the study resultsAcross the six studies, the intervention groups (IGs) consistently demonstrated superior outcomes compared with the control groups (CGs). The effective rates of the IGs were higher than those of CGs in all studies. In Bao et al.10), both THI and NPQ scores significantly improved in the IG (p < 0.05). In two studies11,14), TEQ also showed significant improvements in IG (p < 0.05). Regarding BFV, Bao et al.10) reported significant increases in both VAV and BAV (p < 0.05), whereas Guo12) observed improvement only in the BAV (p < 0.05). In contrast, Jin et al.15), found no significant differences in either BAV or bilateral VAV between groups.
DiscussionTinnitus is a multifactorial neurological symptom, and early intervention is important to prevent permanent and irreversible damage. In clinical practice, various treatment approaches are used, however, therapeutic responses vary widely among individuals, and the current evidence regarding the efficacy of these treatments remains insufficient1,3). Several case reports16,17) and clinical studies10,15) have suggested that acupotomy may be a viable option for managing tinnitus, however, no comprehensive studies have synthesized RCTs on acupotomy for tinnitus. To establish a foundational body of evidence on the use of acupotomy for tinnitus, our study was conducted.
This review synthesized current clinical research on the use of acupotomy for tinnitus symptoms, focusing on six RCTs extracted from seven databases, most of which were conducted in China. Regarding the baseline characteristics of the included studies, the mean age of participants was relatively homogeneous, with four of six studies reporting mean ages in the 40s and one in the 30s. In contrast, the duration of tinnitus symptoms varied substantially, ranging from approximately 18–19 weeks to 6 years, complicating direct comparisons across trials. With respect to treatment points, tenderness or painful nodules—sites that may differ depending on each patient’s condition—were the most frequently selected. Therefore, while this point-selection strategy appears clinically reasonable, it may also have contributed to heterogeneity among participants and studies. In all included studies, the IGs that received acupotomy in combination with other therapies generally demonstrated significantly greater improvements in outcome measures compared with the CGs. However, the outcome assessments in all studies relied primarily on global efficacy indicators and self-reported questionnaires, with no use of psychoacoustic measures. Consequently, the studies synthesized in this review focused mainly on the functional and emotional impacts of tinnitus, while changes in its sensory characteristics of the symptoms were not evaluated. This trend—previously noted in 200818) persisted in studies published between 2016 and 2025.
The most frequently mentioned treatment points were the inferior nuchal line and the spinous process of C2. The Function of the dorsal cochlear nucleus (DCN) is influenced by the somatosensory system. Inputs from the trigeminal, facial, vestibulocochlear, and vagus nerves, as well as the dorsal root ganglia of C2 are transmitted to the DCN. The reason the inferior nuchal line was selected as a treatment point in five studies is likely to be because the suboccipital triangle, located near the inferior nuchal line, is an important region associated with the somatosensory system. Furthermore, the spinous process of C2 was selected in four studies, which may be attributed to the anatomical connection between the dorsal root ganglia of C2 and the auditory system19,20). Of the six included studies, four studies were about cervicogenic tinnitus. Even in two studies not diagnosed as cervicogenic tinnitus, treatment approaches predominantly targeted points in the cervical region. This observation suggests that recent acupotomy research has primarily explored the therapeutic effects on alleviating tinnitus through stimulation of cervical structures functionally related to the auditory system.
Our review has several limitations. First, the methodological quality of the included studies was generally at high risk of bias. None of the trials reported allocation concealment, and prior registration of the RCT protocols was reported in only one study. In addition, due to clear differences between the intervention and control treatments, blinding of participants and practitioners was not feasible, which may have introduced performance and detection bias. Second, acupotomy was applied not as a standalone intervention but as a concomitant therapy. Consequently, evaluating the independent therapeutic effect of acupotomy was difficult, as improvements in the IGs may have been influenced by concurrent treatments. Third, there was heterogeneity in outcome measures across studies, which limited quantitative comparisons. Finally, the number of included studies was small, and all were published in China. Therefore, geographical and publication bias may be present.
Future research on acupotomy for tinnitus should include rigorously designed RCTs with improved methodological quality. In particular, the development of feasible blinding strategies, clear descriptions of randomization procedures, and prior registration of study protocols will be critical to reducing bias and enhancing reliability. Furthermore, the adoption of more validated and standardized outcome indicators may enable comparisons among studies and minimize bias.
ConclusionThe findings from the six included studies suggest that acupotomy may be a promising adjunctive therapy for managing tinnitus. Nevertheless, future rigorously designed RCTs employing validated outcome measures and acupotomy as an independent intervention are required to confirm these findings and clarify its independent therapeutic role in tinnitus management.
References1. Baguley, D., McFerran, D., & Hall, D. (2013). Tinnitus. Lancet (London, England), 382(9904), 1600-1607. https://doi.org/10.1016/S0140-6736(13)60142-7
2. Langguth, B., Kreuzer, P. M., Kleinjung, T., & De Ridder, D. (2013). Tinnitus: causes and clinical management. Lancet Neurol, 12(9), 920-930. https://doi.org/10.1016/S1474-4422(13)70160-1
3. Han, B. I., Lee, H. W., Kim, T. Y., Lim, J. S., & Shin, K. S. (2009). Tinnitus: characteristics, causes, mechanisms, and treatments. J Cli Neurol, 5(1), 11-19. https://doi.org/10.3988/jcn.2009.5.1.11
4. Jeong, J., Lee, H. Y., Choo, O. S., Kim, H., Lee, K. Y., Song, J. J., Seo, J. H., Rah, Y. C., Song, J. J., Nam, E. C., Park, S. N., Moon, I. S., & Shim, H. J. (2025). Consensus Statements on Tinnitus Treatment: A Delphi Study by the Korean Tinnitus Study Group. J Korean Med Sci, 40(18), e75. https://doi.org/10.3346/jkms.2025.40.e75
5. Huang, K., Liang, S., Chen, L., & Grellet, A. (2021). Acupuncture for tinnitus: a systematic review and meta-analysis of randomized controlled trials. Acupunct Med, 39(4), 264-271. https://doi.org/10.1177/0964528420938380
6. Yoo, H. J., Kim, K. J., & Kim, Y. S. (2020). A review on tinnitus treatment in Korean medicine by analyzing case studies published in Korean Journal. J Korean Med Ophthalmol Otolaryngol Dermatol, 33(3), 86-98. https://doi.org/10.6114/jkood.2020.33.3.86
7. Han, J. H., Lim, H. G., Kim, J. H., Heo, E. S., Choi, G., & Choi, S. H., et al (2023). Recent research analysis in acupotomy. J Acupunct Res, 40, 1-15. https://doi.org/10.13045/jar.2022.00262
8. Yoon, S. H., Kim, Y. S., Jo, H. G., & Kwon, C. Y. (2019). Current Usage of Terminologies Related to Acupotomy: A Literature Research and Standardization Suggestion. Chin J Integr Med, 25(2), 147-150. https://doi.org/10.1007/s11655-018-3015-1
9. Higgins, J. P. T., Thomas, J., Chandler, J., Cumpston, M., Li, T., Page, M. J., et alCochrane handbook for systematic reviews of interventions [Internet]. Version 6.5 Cochrane. (2024). Aug. [cited 2025 Sep 29]. Available from: https://www.cochrane.org/handbook
10. Bao, L., & Li, F. (2024). Clinical observation of micro needle knife combined with warm acupuncture in the treatment of cervical tinnitus. Journal of Guangxi University of Chinese Medicine, 27(3), 9-13.
11. He, X., Huang, J., Li, B., Lin, H., & Feng, S. (2022). [Clinical observation of “T”-shaped release with small needle knife in the treatment of sudden deafness of qi-stagnation and blood-stasis type]. Journal of Emergency in Traditional Chinese Medicine, 31(10), 1829-1831. (in Chinese).
12. Guo, J. (2021). [Clinical observation of micro needle knife combined with cervical rotation and lifting manipulation for 30 cases of cervicogenic tinnitus]. Zhejiang Journal of Traditional Chinese Medicine, 56(9), 663-666. https://doi.org/10.13633/j.cnki.zjtcm.2021.09.026 (in Chinese)
13. Jin, Y., Zhu, M., & Chen, J. (2019). [Clinical observation of cervical rotation-lifting manipulation combined with micro needle knife therapy for cervicogenic tinnitus]. Electronic Journal of Clinical Medical Literature, 6(51), 13-14. https://doi.org/10.16281/j.cnki.jocml.2019.51.010 (in Chinese)
14. Fang, X., Zhang, Q., & Yu, S. (2018). [Efficacy of self-made Qing’er decoction combined with painless precision needle knife in the treatment of damp-heat type neurogenic tinnitus]. Jiangxi Medical Journal, 53(6), 613-615. https://doi.org/10.3969/j.issn.1006-2238.2018.6.035 (in Chinese)
15. Jin, Y., Li, S., Sun, R., Zhu, X., Liu, Z., & Shen, Y., et al (2017). Clinical research of needle-knife combined with stellate ganglion block in the treatment of cervicogenic tinnitus. China Medical Herald, 14(21), 159-162.
16. Park, S., Jea, H. K., Min, Y. E., Hong, E. B., & Lee, N. H. (2023). Three cases of pulsatile tinnitus improved by acupotomy with acupuncture. J Korean Med, 44(1), 99-107. https://doi.org/10.13048/jkm.23009
17. Song, J., & Jung, S. (2022). A case report of 18-year chronic tinnitus treated by Korean medicine complex treatment. J Korean Med Soc Acupotomology, 6(2), 123-127. https://doi.org/10.54461/JKMST.2022.6.2.123
18. Meikle, M. B., Stewart, B. J., Griest, S. E., & Henry, J. A. (2008). Tinnitus outcomes assessment. Trends Amplif, 12(3), 223-235. https://doi.org/10.1177/1084713808319943
19. Wadhwa, S., Jain, S., Patil, N., & Jungade, S. J. (2024). Cervicogenic Somatic Tinnitus: A Narrative Review Exploring Non-otologic Causes. Cureus, 16(7), e65476. https://doi.org/10.7759/cureus.65476
20. Jung, M., Lee, J. H., Kang, J. H., Jin, S. Y., & Lim, K. (2022). Characteristics of Each Type of Tinnitus and Proposal of Treatment for Somatic Tinnitus. J Korean Med Soc Acupotomology, 6(1), 16-23. https://doi.org/10.54461/JKMST.2022.6.1.16
|
|
|||||||||||||||||||||||||||||||