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Clinical Efficacy of Tinnitus Retraining Therapy Based on Tinnitus Questionnaire Score and Visual Analogue Scale Score in Patients with Subjective Tinnitus.

Introduction

Tinnitus can be a potentially debilitating symptom physically, emotionally, and socially. The underlying pathophysiology is unclear, which makes the treatment disputable. There are a variety of treatment modalities for chronic subjective tinnitus, but very few have stood the test of time (1). Pharmacotherapy, including the use of lidocaine and tranquilizers, surgical treatment (1), and trans-cranial magnetic stimulation (2) has been exploited for its management. Tinnitus retraining therapy (TRT) was first described by JastrebofF and JastrebofF (3). It is a practical implementation of neurophysiological model of tinnitus that includes counseling and sound therapy (aided or unaided). Sound therapy aims to decrease the dissimilitude between phantom sound and background neuronal activity. It interferes with the brain's ability to detect the tinnitus signal, and thereby, reduces the abnormal gain in the auditory system (3). In this study, we assessed the efficacy of TRT based on tinnitus questionnaire score (TQS) and visual analogue scale (VAS) score.

Methods

This study is a prospective, randomized, single blinded study including 58 patients with subjective tinnitus, who visited our institution during 2015-2016. The Institutional Review Board approval was obtained (approval number: SKNMC No/Ethics/App/2014/236, dated 23/07/2014). The study was performed according to the ethical standards and guidelines of Helsinki Declaration. Patients who did not experience relief with medication and had chronic (>1year), non-pulsatile, continuous, or unilateral tinnitus were included in the TRT program. Informed consent was obtained from all the patients. Each patient underwent clinical and audiological examinations. Patients with tinnitus associated with middle ear disease or Meniere's disease, general debility, or central tinnitus were excluded from the study. The age of the patient and the average duration of tinnitus were recorded. Pure tone audiometry (GSI 61-Innovative technologies USA) was performed to evaluate the parameters as follows: the mean hearing threshold of four frequencies (500, 1000, 2000, and 4000Hz), the pitch match test determining the pure tone frequency most similar to the phantom sound, and the loudness balance test obtaining the pure tone value (dB) giving equivalent loudness of tinnitus sound. TQS and the tinnitus severity grade (TSG), based on the tinnitus questionnaire sheet (Table 1, 2) and the VAS score (Figure 1) were documented before therapy. TRT was administered in the form of two strategies as per the neurophysiological model. First strategy was counseling and the second was sound therapy. Counseling was carried out by an otologist. It was aimed at eliminating the patients' anxiety and increasing their knowledge about tinnitus. It included deep relaxation exercises and stress management. Sound therapy was administered in the form of relatively broad-band, neutral sound, produced by wearable ear-level devices, which included tinnitus maskers [broad-band sound generators (SGs)], hearing aids, or SG-hearing aid combination instruments. This was administered as per the hearing status of the patient. The severity of tinnitus was graded as 1-5 based on TQS (Table 2). The patients with grade 1 tinnitus were treated with counseling alone and those with grade 2 and onwards were treated with the combination of counseling and sound therapy. TQS and TSG, based on Tinnitus Questionnaire sheet (Table 1), and the VAS score were documented two and six months after therapy. VAS score was documented from 0-10 (in terms of volume and disturbance); 0 score indicates no tinnitus and 10 score indicates catastrophic tinnitus (Figure 1).

Based on the improvement in the TQS and VAS score, the clinical efficacy of TRT was analyzed. For statistical evaluation of TSG before and after TRT, Pearson's Chi-square test and Fisher's exact probability tests were used. Comparison between VAS score before and after TRT was performed using the Mann-Whitney U test (SPSS software - SAS Institute, USA). A p value of <0.05 was considered to be significant. The odds ratios and 95% confidence intervals (CI) were added if p values were less than 0.05. Correlation between TQS and VAS was obtained through the Spearman's coefficient correlation. This coefficient varied between -1 to +1. Closer the value is to -1 or +1, stronger is the association, and closer it is to zero, weaker is the association. If the value is closer to -1, it suggests an inverse association between the variables.

Results

A total of 58 patients (32 males and 26 females) with median age of 62 y (28-75 years) received TRT for six months. The average duration of tinnitus was 17 months (12-28 months). The average hearing threshold, tinnitus pitch, and tinnitus loudness were 33.25 (standard deviation[+ or -]10.6) dB, 4000 Hz, and 55 dB, respectively (Table 3). Tinnitus was most commonly associated with presbycusis (n=35). Sudden deafness was observed in two patients, noise-induced hearing loss in one patient, and trauma in four patients. In 16 patients, the tinnitus was idiopathic. The TSG based on TQS was documented before TRT and two and six months after TRT (Table 4, Figure 2).

Statistical analysis with Pearson's Chi square test showed the Chi square value of 74.11 with 3 degree of freedom and 95 degree CI; Cramer's V=0.6782. The p value was <0.00001. Fisher's exact probability test (cross validated) showed p value of 0.000. Statistically significant difference was noted in TSG before TRT and after TRT for 6 months.

Visual analogue scale score was documented before TRT and at two and six months after TRT (Table 5, Figure 3). The average VAS score before TRT was 6.7[+ or -]2.1. After TRT, at 2 months follow up, the average VAS score was 3.2[+ or -]2.4, and at 6 months, it was 2.1[+ or -]2.6. The Mann-Whitney test showed U-value of 26 and Z-score of 3.82543. The p value was found to be 0.00012. Statistically significant difference was observed in the VAS scores before TRT and after TRT. According to the Spearman's relation coefficient, we observed that there is a significant correlation between TQS and VAS score (rs=0.684; p=0.0001; n=58). Therefore, higher the VAS score, higher is the TQS and TSG.

Discussion

Tinnitus represents a symptom of an underlying condition rather than a disease itself. The most common type of tinnitus is subjective tinnitus, which is sensorineural in origin. The pathophysiological cause of tinnitus remains unclear, but a widely accepted theory states that it involves hyperactive hair cells or nerve fibers activated by a chemical imbalance across cell membrane or by the decoupling of stereocilia (1, 4). TRT was described by Jastreboff and Hazell in early 1990s. It is the practical implementation of the neurophysiological model of tinnitus proposed by Jastreboff in 1980 (1, 4). According to this model, in patients with chronic subjective tinnitus, the limbic system and the autonomous nervous system prioritizes tinnitus sound, and the sound is perceived as loud and persistent. The end goal of TRT is the complete habituation of phantom sound.

Counseling should be conducted preferably by an otologist because a background knowledge of auditory pathophysiology and hearing loss definitely aids in achieving successful targeted therapy. (4). We included deep relaxation exercises and stress management in the counseling so as to relieve patients' anxiety. Tinnitus was not the focus of attention for this therapy because the goal was to achieve better relaxation and the ability to sleep. This in turn improved the patients' quality of life and helped in achieving rapid relief and sense of control. Stress management included Tai Chi, yoga, meditation, muscle relaxation, and visual imagery. The training sessions were conducted at the yoga center of our Institute.

Once the emotional response is removed, habituation follows. The second component of TRT is sound therapy. It aims to remove the tinnitus from conscious perception so as to achieve complete habituation. Desensitization of limbic system and autonomous nervous system is performed by sensory stimulus repetition. After successful execution of the first strategy, the second strategy can be implemented. (5) In the sound therapy, we use a constant low-level broad-band sound (white noise generator) to reduce the difference between phantom sound and background neuronal activity, thereby reducing the activation of limbic system and autonomous nervous system. This in turn reduces the tinnitus detectability at the subconscious level. After successful implementation of the two strategies, the tinnitus signal gets habituated from negative reactions (i.e. limbic and sympathetic portions of the autonomous nervous systems) and from conscious perception (5, 6).

Sound generator is a small device that resembles a hearing aid. We used SG in patients with normal hearing or mild sensorineural hearing loss. For severe hearing loss, hearing aids with built-in SGs were used. In our study, we observed a step ladder improvement in the TSG, with maximum benefit achieved at six months after therapy. JastrebofF model states that the benefits of TRT treatment increases over time (3). Lux-Wellenhof and Hellweg (7) reported a continued improvement and a sustained benefit over five years, even after the cessation of formal treatment with TRT. In this study, we evaluated the patients till six months after TRT; therefore, we were unable to conclude about further benefits. We propose to continue this research and report the long-term benefits of TRT.

Conclusion

Tinnitus retraining therapy is a useful approach for the amelioration of tinnitus. With continued treatment, TRT may produce best effects. TRT is more effective if patients are graded as per the severity of tinnitus. TQS is a very effective, cheap, and easy method to help the otologist in grading the patients as per the severity of symptoms. In particular, patients with high grade of difficulty with tinnitus benefit most from TRT, which helps them attain lower levels of handicap and severity.

Ethics Committee Approval: Ethics committee approval was received for this study from the Ethics Committee of Smt. Kashibai Navale Medical College.

Informed Consent: Written informed consent was obtained from patients who participated in this study.

Peer-review: Externally peer-reviewed.

Author Contributions: Concept - S.V.N., K.J.S.; Design - S.V.N., K.J.S.; Supervision - S.V.N., K.J.S.; Materials - S.N.; Data Collection and/or Processing - S.N., K.S.; Analysis and/or Interpretation - S.N., K.S.; Literature Search - S.N.; Writing - S.N.; Critical Reviews - S.N., K.S.

Conflict of Interest: The authors have no conflicts of interest to declare.

Financial Disclosure: The authors declared that this study has received no financial support.

References

(1.) Grewal R, Spielmann PM, Jones SE, Hussain SS. Clinical efficacy of tinnitus retraining theapy and cognitive behavioural theapy in the treatment of subjective tinnitus: a systematic review. J Laryngol Otol 2014; 128: 1028-33. [CrossRef]

(2.) Ariizumi Y, Hatanaka A, Kitamura K. Clinical prognostic factors for tinnitus retraining therapy with a sound generator in tinnitus patients. J Med Dent Sci 2010; 57: 45-53.

(3.) Jastreboff P, Jastreboff M. Tinnitus retraining therapy: A different view on tinnitus. ORL J Otorhinolaryngol 2006; 68: 23-9. [CrossRef]

(4.) Henry JA, Schechter MA, Nagler SM, Fausti SA. Comparison of tinnitus masking and tinnitus retraining therapy. J Am Acad Audiol 2002; 13: 559-81.

(5.) Parazzini M, Del Bo L, Jastreboff M, Tognola G, Ravazzani P. Open ear hearing aids in tinnitus therapy: an efficacy comparison with sound generators. Int J Audiol 2011; 50: 548-53. [CrossRef]

(6.) Bauer CA, Berry JL, Brozoski TJ. The effect of tinnitus retraining therapy on chronic tinnitus: A controlled trial. Laryngoscope Investig Otolaryngol 2017; 2: 4: 166-77. [CrossRef]

(7.) Lux-Wellenhof G, Hellweg FC. Longterm follow up study of TRT in Frankfurt. In: Patuzzi R, editor. Proceedings of the 7th International Tinnitus Seminar. Crawley, Western Australia: 2002. pp. 277-9.

Sanjana Vijay Nemade [iD], Kiran Jaywant Shinde [iD]

Department of Otorhinolaryngology, Smt. Kashibai Navale Medical College and General Hospital, Maharashtra, India

Corresponding Author:

Sanjana Vijay Nemade; drsanjana31@yahoo.in

Received Date: 09.12.2017

Accepted Date: 14.04.2018

ORCID IDs of the authors:

S.V.N. 0000-0001-8330-6870; K.J.S. 0000-0002-8772-6626

Cite this article as: Nemade SV, Shinde KJ. Clinical Efficacy of Tinnitus Retraining Therapy Based on Tinnitus Questionnaire Score and Visual Analogue Scale Score in Patients with Subjective Tinnitus. Turk Arch Otorhinolaryngol 2019;57(1): 34-8.

DOI: 10.5152/tao.2019.3091
Table 1. Tinnitus questionnaire sheet and score

Sr. No   Question                          Yes   Sometimes   No
                                           (A)   (B)         (C)

 1       Because of your tinnitus,
         is it difficult for you
         to concentrate?
 2       Does the loudness of
         your tinnitus make it
         difficult for you to
         hear people?
 3       Does your tinnitus make
         you angry?
 4       Does your tinnitus make
         you feel confused?
 5       Because of your tinnitus,
         do you feel desperate?
 6       Because of your tinnitus, do
         you have trouble falling
         to sleep at night?
 7       Do you feel as though
         you cannot escape your
         tinnitus?
 8       Does your tinnitus interfere
         with your ability to enjoy
         your social activities
         (such as going out to dinner,
         to the movies)?
 9       Because of your tinnitus,
         do you feel frustrated?
10       Does your tinnitus interfere
         with your job or
         household responsibilities?
11       Because of your tinnitus,
         do you find that you
         are often irritable?
12       Because of your tinnitus,
         is it difficult for you to read?
13       Because of your tinnitus,
         is it difficult for you
         to watch television?
14       Do you feel that your
         tinnitus problem has placed
         stress on your relationships
         with members of your
         family and friends?
15       Do you feel that you
         have no control over your
         tinnitus?
16       Does your tinnitus get
         worse when you are
         under stress?
17       Does your tinnitus make
         you feel insecure?
18       Because of your tinnitus,
         do you often feel tired?
19       Does your tinnitus make
         you feel anxious?
20       Does your tinnitus make
         it difficult to relax in a
         quiet room?
21       Does tinnitus causes you
         to avoid noisy situations.
22       Does tinnitus contributes
         to a feeling of general
         ill health
23       Does your tinnitus makes
         you panicky
24       Does your tinnitus has
         led you to think about suicide
25       Does tinnitus interferes with
         your ability to tell where
         sounds are coming from.
Total                                      A     B           C
                                           x4    x2          x0
                                           Total Score=(Ax4)+(Bx2)+(Cx0)

Tinnitus questionnaire score:

Table 2. Tinnitus severity grade according to tinnitus questionnaire
score

TSG   TQS      Description

1     0-16     Slight: Only heard in quiet environment, very easily
               masked. No interference with sleep or daily activities.
2     18-36    Mild: Easily masked by environmental sounds and easily
               forgotten with activities. May occasionally interfere
               with sleep but not daily activities.
3     38-56    Moderate: May be noticed, even in the presence of
               background or environmental noise, although daily
               activities may still be performed.
4     58-76    Severe: Almost always heard, rarely, if ever, masked.
               Leads to disturbed sleep pattern and can interfere with
               ability to carry out normal daily activities. Quiet
               activities affected adversely.
5     78-100   Catastrophic: Always heard, disturbed sleep patterns,
               difficulty with any activity.

TSG: tinnitus severity grade; TQS: tinnitus questionnaire score

Table 3. Audiological findings of patients

Frequency   Mean Pure tone thresholds
            db (SD) of the affected ear

 500 Hz     21 (9.6)
1000 Hz     33 (16.1)
2000 Hz     38 (7.9)
4000 Hz     41 (8.8)
Mean        33.25 (10.6)

Db: decibels, SD: standard deviation

Table 4. Tinnitus severity grade before and after tinnitus retraining
therapy

Tinnitus Severity   Tinnitus Questionnaire   Before TRT
Grade (TSG)         Score (TQS)              (Number of patients)
                                             (n=58)

1 (Slight)           0-16                     2
2 (Mild)            18-36                     3
3 (Moderate)        38-56                    34
4 (Severe)          58-76                    14
5 (Catastrophic)    78-100                    5
Total                                        58

Tinnitus Severity   After TRT at 2 months   After TRT at 6 months
Grade (TSG)         (Number of patients)    (Number of patients)
                    (n=58)                  (n=58)

1 (Slight)          11                      39
2 (Mild)            14                      12
3 (Moderate)        24                       4
4 (Severe)           7                       2
5 (Catastrophic)     2                       1
Total               58                      58

TRT: tinnitus retraining therapy

Table 5. Visual analogue scale score before and after tinnitus
retraining therapy

VAS score   Before TRT                    After TRT at 2 months
            (Number of patients) (n=58)   (Number of patients) (n=58)

0-3          4                            25
4-7         48                            29
8-10         6                             4
Total       58                            58

VAS score   After TRT at 6 months
            (Number of patients)(n=58)

0-3         49
4-7          7
8-10         2
Total       58

VAS: visual analogue scale; TRT: tinnitus retraining therapy
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Title Annotation:Original Investigation
Author:Nemade, Sanjana Vijay; Shinde, Kiran Jaywant
Publication:Turkish Archives of Otorhinolaryngology
Date:Mar 1, 2019
Words:2664
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