Ultrasound guided stellate ganglion block for the treatment of tinnitus

Abstract

Background

Tinnitus, a common auditory disorder, significantly impacts patient quality of life and lacks universally effective treatments. The integration of advanced imaging technology like ultrasound in therapeutic interventions offers new possibilities in healthcare.

Objective

This study evaluated the efficacy of ultrasound-guided stellate ganglion block as an innovative approach to managing tinnitus.

Methods

Eighty patients with tinnitus were randomly assigned to either a control group receiving standard drug therapy or an observation group treated with ultrasound-guided stellate ganglion block in addition to standard therapy. Key metrics, including clinical effectiveness rates, anxiety scores, and tinnitus disability index scores, were assessed pre- and post-treatment.

Results

Post-treatment outcomes revealed that the observation group exhibited significantly improved anxiety scores (38.74 ± 4.05 vs. 50.45 ± 4.86; P < 0.05) and tinnitus disability index scores (37.8 ± 17.56 vs. 50.4 ± 21.26; P < 0.05) compared to the control group. Additionally, the observation group achieved a 100% clinical efficacy rate, outperforming the control group's 84% (P < 0.05).

Conclusion

Ultrasound-guided stellate ganglion block demonstrates superior efficacy in managing tinnitus compared to conventional drug therapy. This study underscores the potential of integrating advanced ultrasound technology into healthcare to optimize treatment outcomes for auditory disorders.

Keywords

ultrasound technology stellate ganglion block tinnitus anxiety healthcare innovation

1 Introduction

Tinnitus refers to sounds that are not perceived by external sound sources,¹ such as buzzing and hissing. It is a common clinical disorder. If the tinnitus is produced within the body and can be heard by the examiner, it can be categorized as objective tinnitus or body sounds; if there is no specific source of sound within the body, it can be categorized as subjective tinnitus, which is more common. It may result from changes in the response of neurons in the central nervous system to auditory deprivation. Tinnitus is considered acute if it lasts less than 3 months and subacute if it lasts more than 3 months. If the tinnitus lasts longer than 6 months, it is “chronic tinnitus”.² Tinnitus is one of the three intractable diseases of ear diseases, with a high incidence, and the clinical treatment is often not very ideal.³ Due to the persistence of tinnitus, patients will suffer from mental symptoms such as irritability, anxiety and insomnia, and many patients will become depressed and their quality of life will be seriously affected.⁴

The pathogenesis of tinnitus is relatively complex. At present, nutritional nerve, vasodilation or high concentration oxygen therapy are commonly used for treatment.⁵ The FDA has not yet approved any medications specifically for the treatment of tinnitus, but there are drugs that have been found to be effective in treating tinnitus, including local anesthetics, anti-anxiety medications, antidepressants, antihistamines, and others.⁶ Lidocaine is a commonly used tinnitus medication that is effective in relieving tinnitus symptoms. The study found that 19 of 26 patients with subjective tinnitus reported temporary improvement or disappearance of tinnitus symptoms with intravenous lidocaine, leaving room for further improvement in treatment efficiency.⁷

Stellate ganglion block is a technique that can be used as a diagnostic and therapeutic technique for a variety of sympathetically mediated disorders. It is a procedure in which a local anesthetic is injected around the stellate ganglion (the sympathetic ganglion in the neck) for the purpose of inhibiting the flow of sympathetic nerves to the ipsilateral portions of the head, neck, chest, and upper extremities.⁸ With the guidance of ultrasound images, the injection of inferior stellate ganglion block is more precise and the amount of drug is reduced, which further improves the safety of the procedure. Ultrasound guidance is crucial in this method because key structures, such as the esophagus and major arteries, are located along the needle path. The dislocation maneuver used in conventional methods only partially reduces these risks and often increases the likelihood of esophageal puncture.⁹ The advantage of this method lies in the ability of ultrasound to ensure proper needle placement within the fascial plane where the sympathetic chain is located, thereby increasing the selectivity of the block. This approach also helps avoid complications, including retropharyngeal hematoma. In recent times, ultrasound-guided stellate ganglion block, an minimally invasive neurosurgical intervention, has gained gradual traction in the treatment of tinnitus, leveraging its capability to modulate and inhibit sympathetic nerve activity.^10,11

This study aimed to investigate the use of ultrasound-guided stellate ganglion block for the treatment of tinnitus.

2 Methods

2.1 Study design, participants and diagnostic criteria

This study enrolled a total of 80 patients with tinnitus admitted to our hospital between December 2020 and October 2021.Tinnitus was diagnosed according to the Practical Otolaryngology.¹² The diagnosis of tinnitus includes audiometry, tinnitus testing, clinical examination, neuropsychological evaluation, and history taking. The diagnosis of subjective tinnitus relies heavily on the patient's self-report, as only the patient can perceive the tinnitus. Objective tinnitus, on the other hand, can also be heard by others and is more easily recognized. In most cases, objective tinnitus is associated with vascular abnormalities, so its diagnosis is often made in conjunction with radiologic imaging tests such as magnetic resonance imaging (MRI) or computed tomography (CT). The etiology of tinnitus is unclear, and patients may experience persistent or intermittent symptoms, sometimes accompanied by hearing loss, anxiety, depression, and other emotional changes. Inclusion criteria: Patients with chronic subjective tinnitus. Exclusion criteria: Patients with bleeding disorders, heart dysfunction, severe mental illness, or inability to cooperate with treatment were excluded from the study.

2.2 Treatment

The patients were randomly assigned in a ratio of 1:1 using a randomized numerical table method. The control group was administrated with basic drugs alone. The treatment regimen consisted of a 0.67% lidocaine mixture, which was comprised of 5 ml of 2% lidocaine solution diluted with 10 ml of normal saline. A total of 6 days of treatment with intravenous lidocaine once a day constitutes a course of treatment.

The observation group was administrated with ultrasound-guided stellate ganglion block treatment based on basic drug treatment. The patient was positioned in a supine posture, with their neck muscles relaxed, and their head gently turned towards the unaffected side. Utilizing ultrasound guidance, we accurately identified the transverse process of the sixth cervical vertebra, along with the longus colli muscle and the prevertebral fascia. Following this, a 5 ml injection of 0.67% lidocaine was administered precisely into the interstitial space between the longus colli muscle and the prevertebral fascia. Successful nerve block was confirmed within 2 to 5 min through the emergence of Horner syndrome.

2.3 Observation indicators

We will use total effective rate, Tinnitus disability assessment scale, and Assessment of anxiety as Observation indicators to characterize the treatment effect.

Tinnitus grade index is the main clinical observation index,¹³ as shown in Table 1. Basic cure refers to the tinnitus grade decreased by 3 or to 0; Significant effect refers to the tinnitus grade decreased by 2 levels; Effective refers to the tinnitus grade decreased by 1 level; Invalid means no change in tinnitus grade. Total effective rate = (basic number of cures + significant number + effective number)/total number of cases ×100%.The Tinnitus Handicap Inventory (THI), widely used internationally, was adopted for the assessment of tinnitus disability.^14,15 THI is categorized into four levels: no disability (0–16 points), mild disability (18–36 points), moderate disability (38–56 points), and severe disability (58–100 points). A score difference of ≥20 points between the pre- and post-treatment assessments was considered statistically significant.

Table 1.
Evaluation indicators and scoring criteria of tinnitus severity.

Evaluation index 0 Point 1 Points 2 Points 3 Points

Environment tinnitus occurs Tinnitus Not occur In quiet Environment In general Environment In any Environment

Duration of tinnitus No tinnitus Intermittent time greater than Duration time Duration greater than Intermittent time Persistent tinnitus

Influence of tinnitus on sleep Have no influence Sometimes affect Frequent influence Always influence

Influence of tinnitus on life and work Have no influence Sometimes affect Frequent influence Always influence

Emotional effects of tinnitus Have no influence Sometimes affect Frequent influence Always influence

Patient's overall feelings about tinnitus Score by the patient according to the actual feeling of the degree of tinnitus (0∼6 points).

Evaluation index	0 Point	1 Points	2 Points	3 Points
Environment tinnitus occurs	Tinnitus Not occur	In quiet Environment	In general Environment	In any Environment
Duration of tinnitus	No tinnitus	Intermittent time greater than Duration time	Duration greater than Intermittent time	Persistent tinnitus
Influence of tinnitus on sleep	Have no influence	Sometimes affect	Frequent influence	Always influence
Influence of tinnitus on life and work	Have no influence	Sometimes affect	Frequent influence	Always influence
Emotional effects of tinnitus	Have no influence	Sometimes affect	Frequent influence	Always influence
Patient's overall feelings about tinnitus	Score by the patient according to the actual feeling of the degree of tinnitus (0∼6 points).

Note: Based on the performance of the latest week, the occurrence time ≤1/5 is defined as “sometimes”, ≥2/3 is defined as “always”, and between the two is defined as “often”. Light to heavy is divided into I∼V grades. Grade I: 1∼6 points; Grade II: 7∼10 points, Grade III: 11∼14 points; Grade IV: 15∼18 points; Grade V: 19∼21 points.

Anxiety was assessed using the Self-assessment Anxiety Scale (SAS).¹⁶ A score <50 is considered normal, while a score between 50–60 indicates mild anxiety. A score between 61–70 indicates moderate anxiety and a score >70 indicates severe anxiety. A higher SAS score corresponds to a higher level of anxiety in the patient.

2.4 Statistical analysis

Statistical analysis was conducted using SPSS Statistics version 21.0 (IBM, Armonk, NY, USA). Continuous data with a normal distribution were presented as means ± standard deviations and analyzed using Student's t-test. For data with skewed distribution, they were described as medians (interquartile range, IQR) and analyzed using the Mann-Whitney U test. Categorical data were presented as n (%) and analyzed using the chi-square test or Fisher's exact test. Two-sided p-values <0.05 were considered statistically significant.

3 Results

A total of 80 tinnitus patients (41 males) were collected, with 40 patients treated using ultrasound-guided stellate ganglion block. The age, gender, and course of disease between the two groups were comparable (all P > 0.05) (Table 2). Basic demographic and clinical information for two groups of patients included in the study is presented. Both groups consist of 40 patients. The observation group includes 19 males and 21 females, while the control group includes 22 males and 18 females. In the observation group, the average disease duration is 8.3 ± 0.6 months, compared to 8.2 ± 0.8 months in the control group. The average age of patients in the observation group is 44 ± 5 years, and in the control group, it is 43 ± 6 years.

Table 2.
Comparison of general information between the two groups.

Sex

Group Number of patients Male Female Course of disease (X ± S, month) Age (X ± S, years)

Observation group 40 19 21 8.3 ± 0.6 44 ± 5 ^1’

Control group 40 22 18 8.2 ± 0.8 43 ± 6

		Sex
Observation group	40	19	21	8.3 ± 0.6	44 ± 5 ^1’
Control group	40	22	18	8.2 ± 0.8	43 ± 6

Note: Compared with the Control Group, ^1’P > 0.05.

3.1 Comparison of the clinical effective rate

The effective rates of the observation group were significantly higher than those of the control group (100% vs 84%, P < 0.05) (Table 3).

Table 3.
Comparison of efficacy between the two groups (%).

No. of Remarkable Total

Group patients Cured effective Effective Invalid effective rate

Observation group 50 4 (8) 13 (26) 33 (66) 0 50 (100)^1’

Control group 50 1 (2) 10 (20) 31 (62) 8 (16) 42 (84)

	No. of		Remarkable			Total
Observation group	50	4 (8)	13 (26)	33 (66)	0	50 (100)^1’
Control group	50	1 (2)	10 (20)	31 (62)	8 (16)	42 (84)

Note: Compared with the control group, ^1’P < 0.05.

3.2 Comparison of tinnitus disability scores and anxiety scores

Before treatment, the anxiety scores and tinnitus disability assessment scale scores were comparable between the observation group and the control group (both P > 0.05). After treatment, the observation group have a significantly lower anxiety scores (38.74 ± 4.05 vs 50.45 ± 4.86, P < 0.05). and tinnitus disability assessment scale scores (37.8 ± 17.56 vs 50.4 ± 21.26, P < 0.05) than those of the control group (Tables 4 and 5).

Table 4.
Score of tinnitus disability assessment scale in two groups.

Group No. of patients Pre-treatment Post-treatment

Observation group 50 63.17 ± 20.56 37.8 ± 17.56 ^{1’ 2’}

Control group 50 62.37 ± 20.81 50.4 ± 21.26 ^1’

Group	No. of patients	Pre-treatment	Post-treatment
Observation group	50	63.17 ± 20.56	37.8 ± 17.56 ^{1’ 2’}
Control group	50	62.37 ± 20.81	50.4 ± 21.26 ^1’

Note: Compared within the sane group, ^1’P < 0.05; Compared with that of post-treatment in Control Group, ^2’P < 0.05.

Table 5.

Comparison of anxiety scores between the two groups.

Group	No. of patients	Pre-treatment	Post-treatment
Observation group	50	55.68 ± 5.34	38.74 ± 4.05 ^{1’ 2’}
Control group	50	54.68 ± 5.63	50.45 ± 4.68 ^1’

Note: Compared with that of pre-treatment within the same group, ^1’P < 0.05; Compared with that of post-treatment in Control Group, ^2’P < 0.05.

4 Discussion

The results suggest that ultrasound-guided stellate ganglion block significantly improved clinical efficacy, reduced anxiety levels, and decreased tinnitus disability index scores compared to basic drug treatment in patients with tinnitus. These results may provide a valuable treatment for patients with tinnitus.

Tinnitus is a complex symptom that can significantly disrupt an individual's quality of life.¹⁷ The underlying mechanisms are not fully understood, but it is widely accepted that it involves aberrant neural activity in the central auditory pathway.¹⁸ Abnormal neural pathways can also lead to abnormal blood flow and insufficient blood supply to the auditory center, resulting in tinnitus.¹⁹ Clinically, patients who seek medical treatment for tinnitus are accompanied by different degrees of adverse psychological reactions.²⁰ By targeting the stellate ganglion, we hypothesize that this intervention modulates the sympathetic nervous system, which may play a role in the pathophysiology of tinnitus.

Ultrasound-guided stellate ganglion block tranquilizes the cervical sympathetic nerve, thereby harmonizing the autonomic and immune systems. This manipulation rectifies neural pathways, potentially alleviating neurological tinnitus.²¹ Ultrasound-guided stellate ganglion block amplifies cerebral and internal carotid circulation, tames sympathetic nerve hyperactivity, and widens peripheral blood vessels. By intercepting noradrenaline and neuropeptides, it muzzles the postganglionic sympathetic nerve fibers. Consequently, the vascular diameter broadens, blood flow and velocity surge, and the inner ear's microcirculatory chaos subsides.^21,22 The stellate and middle cervical ganglia's postganglionic fibers link to the cochlear vessels sparsely, likely confining their distribution to larger vessels. In stark contrast, fibers from the superior cervical ganglion are omnipresent along the basilar artery and throughout the cochlear artery.²³ Since the preganglionic fibers of both superior and middle cervical ganglia transverse stellate ganglia, obstructing these ganglia simultaneously halts the superior and middle cervical ganglia. This dual-pronged approach augments cochlear artery blood flow and velocity, significantly bolstering the inner ear's nutritional and oxygen supply.²⁴

Tinnitus patients are often accompanied by varying degrees of anxiety, and currently, it is generally believed that hypothalamic-pituitary-adrenal axis hyperfunction is one of the neurobiological bases of anxiety.²⁵ A previous study reported that ultrasound-guided stellate ganglion block can effectively treat mild to moderate anxiety.¹¹ This study found that ultrasound-guided stellate ganglion block may decrease the psychological anxiety of patients. From these three aspects, we corrected the pathophysiological process of tinnitus development and improved the cure rate of tinnitus. In addition, the stele ganglion block has mature clinical operation technology, stable safety, and nearly 100 years of clinical application. Especially, under the guidance of ultrasound, the puncture situation can be visually seen, and important blood vessels, important structures and nerves can be avoided during treatment, to avoid risks and complications in the puncture journey. Observe the immediate distribution of the liquid during injection and adjust the tip immediately to improve safety and effectiveness.

In this work stellate ganglion block demonstrated a remarkable 100% efficacy rate compared to 84% in the control group, underscoring its superiority as a treatment for tinnitus. This highlights its potential to not only alleviate symptoms effectively but also provide consistent clinical outcomes, making it a promising therapeutic option for managing this challenging condition.

In the study conducted by Zhu et al. (2021), it was demonstrated that the group treated with ultrasound-guided therapy showed significantly higher efficacy (96.06%) compared to the group treated with the blind method (76.47%) in improving hearing thresholds. Additionally, the results indicated that the success rate of the first puncture was higher with ultrasound guidance, while the complication rate was 0%. The study concluded that ultrasound-guided stellate ganglion block is safer and more effective, offering better clinical outcomes and a lower risk of complications compared to the blind method.²⁶ In the study conducted by Li et al. (2024), the efficacy of stellate ganglion block (SGB) as an adjunctive treatment for chronic subjective tinnitus was evaluated. The results showed that SGB is a safe and effective treatment, with an overall efficacy rate of 89%. No adverse effects were reported, leading to the conclusion that SGB may be a safe option for patients with more severe forms of tinnitus.²⁷

Although there have been a previous case of successful cure of tinnitus in combination with ultrasound-guided stellate ganglion block, there was only one case, and the therapeutic effect was fortuitous.²⁴ In contrast, 80 patients were included in this study and divided equally into a basic drug treatment group and an ultrasound-guided stellate ganglion block treatment group. It was found that building on the efficacy of lidocaine, utilizing the ultrasound-guided stellate ganglion block technique reduced the patient's anxiety level while relieving tinnitus symptoms. The clinical efficacy rate for patients reached 100%, strongly validating the feasibility of this clinical treatment option.

This study is subject to a few key limitations. Firstly, the sample size was relatively small. Secondly, the single-center design may limit the generalizability of the findings. Thirdly, the short follow-up period of 6 days after treatment may not adequately assess the long-term efficacy of ultrasound-guided stellate ganglion block for tinnitus. The multicenter randomized controlled trials with longer follow-up periods were needed to validate the effect of ultrasound-guided stellate ganglion block for tinnitus treatment.

5 Conclusion

Our study demonstrated that ultrasound-guided stellate ganglion block significantly improves tinnitus symptoms and reduces anxiety more than standard drug therapy.

Future research should focus on validating the long-term efficacy and safety of stellate ganglion block through larger, multicenter randomized controlled trials. Further exploration of the mechanisms behind stellate ganglion block's therapeutic effects on the sympathetic nervous system and central auditory pathways is also warranted. Investigating the combination of stellate ganglion block with other modalities like cognitive-behavioral therapy or sound therapy may optimize treatment protocols for tinnitus.

In summary, ultrasound-guided stellate ganglion block emerges as a promising treatment for tinnitus, with evidence of improved clinical outcomes and reduced anxiety from this study. Future research should build on these findings and clarify the role of stellate ganglion block in tinnitus management.

Footnotes

Ethical compliance

This study was reviewed by the Ethics Committee of The Third People's Hospital of Henan Province (Approval Number: 2024-SZSYKY-018). Prior to participation, all patients and/or their legal guardians received detailed information about the study's purpose, procedures, potential risks, and benefits. Signed written informed consent was subsequently obtained to ensure their voluntary participation and full understanding of the research protocol.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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		Sex
Group	Number of patients	Male	Female	Course of disease (X ± S, month)	Age (X ± S, years)
Observation group	40	19	21	8.3 ± 0.6	44 ± 5 ^1’
Control group	40	22	18	8.2 ± 0.8	43 ± 6

	No. of		Remarkable			Total
Group	patients	Cured	effective	Effective	Invalid	effective rate
Observation group	50	4 (8)	13 (26)	33 (66)	0	50 (100)^1’
Control group	50	1 (2)	10 (20)	31 (62)	8 (16)	42 (84)

Ultrasound guided stellate ganglion block for the treatment of tinnitus

Abstract

Background

Objective

Methods

Results

Conclusion

Keywords

1 Introduction

2 Methods

2.1 Study design, participants and diagnostic criteria

2.2 Treatment

2.3 Observation indicators

3 Results

Table 2. Comparison of general information between the two groups. Sex Group Number of patients Male Female Course of disease (X ± S, month) Age (X ± S, years) Observation group 40 19 21 8.3 ± 0.6 44 ± 5 1’ Control group 40 22 18 8.2 ± 0.8 43 ± 6

Table 3. Comparison of efficacy between the two groups (%). No. of Remarkable Total Group patients Cured effective Effective Invalid effective rate Observation group 50 4 (8) 13 (26) 33 (66) 0 50 (100)1’ Control group 50 1 (2) 10 (20) 31 (62) 8 (16) 42 (84)

Table 4. Score of tinnitus disability assessment scale in two groups. Group No. of patients Pre-treatment Post-treatment Observation group 50 63.17 ± 20.56 37.8 ± 17.56 1’ 2’ Control group 50 62.37 ± 20.81 50.4 ± 21.26 1’

5 Conclusion

Footnotes

Ethical compliance

Funding

Declaration of conflicting interests

References

Table 2.
Comparison of general information between the two groups.

Sex

Group Number of patients Male Female Course of disease (X ± S, month) Age (X ± S, years)

Observation group 40 19 21 8.3 ± 0.6 44 ± 5 ^1’

Control group 40 22 18 8.2 ± 0.8 43 ± 6

Table 3.
Comparison of efficacy between the two groups (%).

No. of Remarkable Total

Group patients Cured effective Effective Invalid effective rate

Observation group 50 4 (8) 13 (26) 33 (66) 0 50 (100)^1’

Control group 50 1 (2) 10 (20) 31 (62) 8 (16) 42 (84)

Table 4.
Score of tinnitus disability assessment scale in two groups.

Group No. of patients Pre-treatment Post-treatment

Observation group 50 63.17 ± 20.56 37.8 ± 17.56 ^{1’ 2’}

Control group 50 62.37 ± 20.81 50.4 ± 21.26 ^1’