Pilot study on the role of somatic modulation in hyperacusis.

BACKGROUND: Hyperacusis is a reduced tolerance to sounds that often co-occurs with tinnitus. Both symptoms have convergent as well as divergent characteristics. Somatic modulation, changes in pitch or loudness during certain movements, is common in patients with a primary complaint of tinnitus. However, thus far, this is not documented in patients with hyperacusis. OBJECTIVES: This study aimed to examine the influence of somatic manoeuvres on the perception of external sounds in patients with a primary complaint of hyperacusis. METHODOLOGY: In this prospective cross-sectional pilot study, 18 patients with a primary complaint of hyperacusis were recruited at the Tinnitus Treatment and Research Center Antwerp (TINTRA). While patients listened to a 1 kHz broadband noise of 30 dB sensation level, six neck manoeuvres (flexion, extension, lateroflexion left/right, traction and compression), three jaw manoeuvres (protrusion, laterotrusion left/right) and one placebo manoeuvre (hand on head) were performed. The primary outcome measure was the change in the perception of the presented sound in terms of loudness and intrusiveness between baseline and each modulation measured by a visual analogue scale (VAS). RESULTS: No overall significant changes were found; however, individual results indicated that five patients presented a clinically relevant change of more than three points out of ten on VAS in terms of hyperacusis after at least one of the executed somatic manoeuvres. CONCLUSIONS: This pilot study did not demonstrate an overall significant change in hyperacusis after somatic manoeuvres but does not rule out the possibility of somatic modulation in some hyperacusis patients. TRIAL REGISTRATION: The protocol of this prospective cross-sectional pilot study was registered on clinicaltrials.gov with registration number NCT04693819.

The Rapid Screening for Somatosensory Tinnitus Tool: a Data-Driven Decision Tree Based on Specific Diagnostic Criteria.

BACKGROUND: Somatosensory or somatic tinnitus (ST) is a type of tinnitus where changes in somatosensory afference from the cervical spine or temporomandibular area alter the tinnitus perception. Very recently, the diagnostic value of a set of 16 diagnostic criteria for ST was determined. The next step in the development of easily applicable diagnostic criteria is to provide an uncomplicated model, based on the existing criteria, which can easily be used in clinical practice. OBJECTIVES: This study aims to construct an accurate decision tree, combining several diagnostic criteria, to optimize both sensitivity and specificity of ST diagnosis. DESIGN: An online survey was launched on the online forum Tinnitus Talk, managed by Tinnitus Hub in a convenience sample of participants with tinnitus. The survey included 42 questions, both on the presence of diagnostic criteria for ST and on other potentially influencing factors. A decision tree was constructed to classify participants with and without ST using the rpart package in R. Tree depth was optimized during a five-fold cross-validation. Finally, model performance was evaluated on a subset containing 20% of the original dataset. RESULTS: Data of 7981 participants were used to construct a decision tree for ST diagnosis. Four criteria were included in the final decision tree: 'Tinnitus and neck/jaw pain increase/decrease simultaneously', 'Tension in suboccipital muscles', 'Somatic modulation', and 'Bruxism'. The presented model has an accuracy of 82.2%, a sensitivity of 82.5%, and a specificity of 79%. Receiver operator characteristic curves demonstrated an area under the curve of 0.88. CONCLUSIONS: Based on a 42-item survey, a decision tree was created that was able to detect ST patients with high accuracy (82.2%) using only 4 questions. The RaSST is therefore expected to be easily implementable in clinical practice.

Cost-effectiveness of a smartphone Application for Tinnitus Treatment (the CATT trial): a study protocol of a randomised controlled trial.

BACKGROUND: Tinnitus is a highly prevalent symptom, affecting 10-15% of the adult population. Tinnitus influenced by alterations in somatosensory afference from the neck or jaw is referred to as somatic tinnitus (ST). ST is known to respond positively to physiotherapy treatment; however, it is challenging to motivate patients to systematically perform home exercises correctly, and the necessary tinnitus counselling is often lacking. The aim of this study is twofold, namely to investigate both the effectiveness and cost-effectiveness of a blended physiotherapy program for ST, including a smartphone application designed to increase exercise therapy compliance and provide tinnitus counselling. METHODS: This study is designed as a single-blind two-arm 1:1 randomised controlled trial (RCT). Adult patients diagnosed with ST, without psychiatric comorbidities and with experience in using a smartphone, will be recruited at the Ear Nose Throat (ENT) department of the Antwerp University Hospital (UZA). Patients will be randomised into two groups. The experimental group will receive the blended physiotherapy program comprising six in-clinic physiotherapy sessions over a period of 12 weeks (1x/2 weeks) and an exercise and counselling program provided by the smartphone application. The control group will receive the standard care program comprising twelve weekly in-clinic physiotherapy sessions. Each physiotherapy session has a duration of 30 min. The primary outcome measure is the change in Tinnitus Functional Index (TFI) score. Additionally, a cost-effectiveness analysis will be performed from a societal perspective considering both direct and indirect costs. There will be follow-up assessments at one and 3 months after the final treatment session. DISCUSSION: Our study is the first to combine both tinnitus counselling and neck/jaw treatment provided by a digital application in a blended physiotherapy program. This, in order to empower ST patients to improve and better manage their own health and, possibly, reduce economic costs by alleviating the tinnitus burden that ST patients experience. The strengths of the planned RCT are the high-quality methodological design, the large sample size and the expertise of the involved multidisciplinary research team. TRIAL REGISTRATION: Clinicaltrials.gov NCT05245318 . Registered on 26 January 2022.

Erosion of the long process of the incus in revision stapes surgery: malleovestibular prosthesis or incus reconstruction with hydroxyapatite bone cement?

OBJECTIVE: To study hearing outcome in revision stapedotomy cases where extensive erosion of the long process of the incus was observed in a consecutive series where a malleovestibular prosthesis was used versus a consecutive series where hydroxyapatite (HA) bone cement was used to rebuild the eroded long process of the incus and integrate the prosthesis. PATIENTS: Twenty revision cases of surgically treated otosclerosis where extensive incus erosion was observed during revision surgery. INTERVENTION: In the earlier consecutive series, 10 cases were treated with malleovestibular prostheses. In the later consecutive series, 10 cases were treated with HA bone cement to rebuild the incus-prosthesis interface. MAIN OUTCOME MEASURES: Air-bone gap, bone-conduction thresholds, and air-conduction thresholds were evaluated preoperatively and at 1 to 3 months. Last audiometry available also was reported (median, 12 mo). Pure-tone averages were calculated according to the guidelines of the Committee on Hearing and Equilibrium for the evaluation of conductive hearing loss. Raw data were displayed in an Amsterdam Hearing Evaluation Plot. RESULTS: Six male patients and 14 female patients were included. Age varied from 34 to 75 years (median, 53 yr). The median postoperative air-bone gap at last follow-up audiometry was 15.6 in the malleovestibular prosthesis group and 13.1 dB in the HA bone cement group. No short-term or intermediate-term adverse reactions or unsuspected bone conduction deteriorations were seen. CONCLUSION: HA bone cement can be successfully used to reconstruct the long process of the incus in case of extensive erosion of the long process. Intermediate-term hearing outcome is comparable to the outcome of a series of similar cases treated with malleovestibular prostheses. Because the placement of a malleovestibular prosthesis is technically more difficult and presents a high risk to the inner ear, we think HA bone cement can be a useful alternative in these difficult cases.

Systematic review of the literature on nitinol prostheses in surgery for otosclerosis: assessment of the adequacy of statistical power.

OBJECTIVE: To perform a systematic review of observational studies reporting hearing outcome in primary stapes surgery where a heat-crimping prosthesis was used. DATA SOURCES: Medline, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, TRIP database, Clinical Trials Registry, ISI Web of Knowledge, and Web of Science. The search was performed on January 1, 2010, including articles published ahead of print. No language restrictions. STUDY SELECTION: Inclusion criteria for qualitative synthesis were a population of otosclerosis patients, intervention being primary stapes surgery with a nickel titanium alloy (Nitinol) heat-crimping prosthesis, and hearing outcome. Inclusion criteria for quantitative analysis: application of audiometry guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Committee on Hearing and Equilibrium for evaluation of conductive hearing loss. DATA EXTRACTION: Strategy and reporting based on Cochrane, Quality of Reporting of Meta-analyses, and Meta-analysis of Observational Studies in Epidemiology statements. A bias assessment tool was developed according to Cochrane guidelines. DATA SYNTHESIS: A quantitative synthesis was performed, but because of the heterogeneity in postoperative follow-up periods and outcome measures reported, we were not able to pool these data. A sample size analysis was performed to indicate the sample needed to demonstrate a statistically significant difference in hearing outcome between both interventions. Hearing outcome superiority of the Nitinol heat-crimping prosthesis over manually crimping prosthesis types was not demonstrated. CONCLUSION: Superiority could probably not be demonstrated because of insufficient sample size. Research addressing technical improvements in stapes surgery should agree on a base sample size able to detect the smallest difference that is clinically important or accept the null hypothesis. With data gathered in the Common Otology Database as basis, a sample size of at least 413 patients is needed in both the intervention and the control group. Other clinical outcome measures also should be explored.