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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Tinnitus | Study protocol

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

Authors: Sara Demoen, Laure Jacquemin, Annick Timmermans, Vincent Van Rompaey, Olivier Vanderveken, Hanne Vermeersch, Iris Joossen, Julie Van Eetvelde, Winfried Schlee, Wim Marneffe, Janis Luyten, Annick Gilles, Sarah Michiels

Published in: Trials | Issue 1/2022

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Abstract

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.
Appendix
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Literature
1.
2.
Crummer RW, Hassan GA. Diagnostic approach to tinnitus. Am Fam Physician. 2004;69(1):120–6.PubMed
3.
Folmer R, Martin W, Shi Y. Tinnitus: questions to reveal the cause, answers to provide relief. J Fam Pract. 2004;53:532–40.PubMed
4.
Cima RF, Andersson G, Schmidt CJ, Henry JA. Cognitive-behavioral treatments for tinnitus: a review of the literature. J Am Acad Audiol. 2014;25(1):29–61.PubMedCrossRef
5.
6.
Aazh H, Moore BCJ, Glasberg BR. Simplified form of tinnitus retraining therapy in adults: a retrospective study. BMC Ear Nose Throat Disord. 2008;8(1):7.PubMedPubMedCentralCrossRef
7.
Henry JA, Dennis KC, Schechter MA. General review of tinnitus: prevalence, mechanisms, effects, and management. J Speech Lang Hear Res. 2005;48(5):1204–35.PubMedCrossRef
8.
Trochidis I, Lugo A, Borroni E, Cederroth CR, Cima R, Kikidis D, et al. Systematic review on healthcare and societal costs of tinnitus. Int J Environ Res Public Health. 2021;18(13):6881.PubMedPubMedCentralCrossRef
9.
Maes IH, Cima RF, Vlaeyen JW, Anteunis LJ, Joore MA. Tinnitus: a cost study. Ear Hear. 2013;34(4):508–14.PubMedCrossRef
10.
Biswas R, Lugo A, Akeroyd MA, Schlee W, Gallus S, Hall DA. Tinnitus prevalence in Europe: a multi-country cross-sectional population study. Lancet Reg Eur. 2022;12:100250.
11.
Michiels S, De Hertogh W, Truijen S, Van de Heyning P. Cervical spine dysfunctions in patients with chronic subjective tinnitus. Otol Neurotol. 2015;36(4):741–5.PubMedCrossRef
12.
Ostermann K, Thill M, Vincent Y, Debaty M, Cotton P, Lurquin P. Incidence of somatic tinnitus in current ENT practice; 2014.
13.
Ward JD, Sutton PC, Werner AD, Costanza R, Mohr SH, Simmons CT. Is decoupling GDP growth from environmental impact possible? PLoS One. 2016;11(10):e0164733.PubMedPubMedCentralCrossRef
14.
Michiels S, Van de Heyning P, Truijen S, Hallemans A, De Hertogh W. Does multi-modal cervical physical therapy improve tinnitus in patients with cervicogenic somatic tinnitus? Man Ther. 2016;26:125–31.PubMedCrossRef
15.
Michiels S, Naessens S, Van de Heyning P, Braem M, Visscher C, Gilles A, et al. The effect of physical therapy treatment in patients with subjective tinnitus: a systematic review. Front Neurosci. 2016;10:545.PubMedPubMedCentralCrossRef
16.
Oostendorp RA, Bakker I, Elvers H, Mikolajewska E, Michiels S, De Hertogh W, et al. Cervicogenic somatosensory tinnitus: an indication for manual therapy? Part 1: theoretical concept. Man Ther. 2016;23:120–3.PubMedCrossRef
17.
Oostendorp RAB, Bakker I, Elvers H, Mikolajewska E, Michiels S, De Hertogh W, et al. Cervicogenic somatosensory tinnitus: an indication for manual therapy plus education? Part 2: a pilot study. Man Ther. 2016;23:106–13.PubMedCrossRef
18.
Van der Wal A, Michiels S, Van de Heyning P, Braem M, Visscher C, Topsakal V, et al. Treatment of somatosensory tinnitus: a randomized controlled trial studying the effect of orofacial treatment as part of a multidisciplinary program. J Clin Med. 2020;9(3):705.PubMedCentralCrossRef
19.
Michiels S, Nieste E, Van de Heyning P, Braem M, Visscher C, Topsakal V, et al. Does conservative temporomandibular therapy affect tinnitus complaints? A systematic review. J Oral Facial Pain Headache. 2019;33(3):308–17.PubMedCrossRef
20.
Gil-Martínez A, Paris-Alemany A, López-de-Uralde-Villanueva I, La Touche R. Management of pain in patients with temporomandibular disorder (TMD): challenges and solutions. J Pain Res. 2018;11:571–87.PubMedPubMedCentralCrossRef
21.
Michiels S, De Hertogh W, Truijen S, Van De Heyning P. The effect of cervical physical therapy in patients with cervicogenic somatic tinnitus. Man Ther. 2016;25:e102.CrossRef
22.
Michiels S, van der Wal AC, Nieste E, Van de Heyning P, Braem M, Visscher C, et al. Conservative therapy for the treatment of patients with somatic tinnitus attributed to temporomandibular dysfunction: study protocol of a randomised controlled trial. Trials. 2018;19(1):554.PubMedPubMedCentralCrossRef
23.
Sluijs EM, Kok GJ, van der Zee J. Correlates of exercise compliance in physical therapy. Phys Ther. 1993;73(11):771–82 discussion 83-6.PubMedCrossRef
24.
Prvu Bettger J, Resnik LJ. Telerehabilitation in the age of COVID-19: an opportunity for learning health system research. Phys Ther. 2020;100(11):1913–6.PubMedPubMedCentralCrossRef
25.
Turolla A, Rossettini G, Viceconti A, Palese A, Geri T. Musculoskeletal physical therapy during the COVID-19 pandemic: is telerehabilitation the answer? Phys Ther. 2020;100(8):1260–4.PubMedCrossRef
26.
Seron P, Oliveros M-J, Gutierrez-Arias R, Fuentes-Aspe R, Torres-Castro RC, Merino-Osorio C, et al. Effectiveness of telerehabilitation in physical therapy: a rapid overview. Phys Ther. 2021;101(6):pzab053.PubMedPubMedCentralCrossRef
27.
Cottrell MA, Galea OA, O’Leary SP, Hill AJ, Russell TG. Real-time telerehabilitation for the treatment of musculoskeletal conditions is effective and comparable to standard practice: a systematic review and meta-analysis. Clin Rehabil. 2017;31(5):625–38.PubMedCrossRef
28.
29.
Nagaraj MK, Prabhu P. Internet/smartphone-based applications for the treatment of tinnitus: a systematic review. Eur Arch Otorhinolaryngol. 2020;277(3):649–57.PubMedCrossRef
30.
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.PubMedPubMedCentralCrossRef
31.
Michiels S, Ganz Sanchez T, Oron Y, Gilles A, Haider HF, Erlandsson S, et al. Diagnostic criteria for somatosensory tinnitus: a Delphi process and face-to-face meeting to establish consensus. Trends Hear. 2018;22:2331216518796403.PubMedPubMedCentral
32.
33.
Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, et al. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012;33(2):153–76.PubMedCrossRef
34.
Rabau S, Wouters K, Van de Heyning P. Validation and translation of the Dutch tinnitus functional index. B-ent. 2014;10(4):251–8.PubMed
35.
Fackrell K, Hall DA, Barry JG, Hoare DJ. Performance of the Tinnitus Functional Index as a diagnostic instrument in a UK clinical population. Hear Res. 2018;358:74–85.PubMedCrossRef
36.
Saghaei MS, Saghaei S. Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials. J Biomed Sci Eng. 2011;4:734–9.CrossRef
37.
van der Wal A, Van de Heyning P, Gilles A, Jacquemin L, Topsakal V, Van Rompaey V, et al. Prognostic indicators for positive treatment outcome after multidisciplinary orofacial treatment in patients with somatosensory tinnitus. Front Neurosci. 2020;14:561038.PubMedPubMedCentralCrossRef
38.
Cardon E, Van Rompaey V, Jacquemin L, Mertens G, Vermeersch H, Joossen I, et al. Sequential dual-site High-Definition transcranial Direct Current Stimulation (HD-tDCS) treatment in chronic subjective tinnitus: study protocol of a double-blind, randomized, placebo-controlled trial. Trials. 2019;20(1):471.PubMedPubMedCentralCrossRef
39.
Luyten TR, Jacquemin L, Van Looveren N, Declau F, Fransen E, Cardon E, et al. Bimodal therapy for chronic subjective tinnitus: a randomized controlled trial of EMDR and TRT versus CBT and TRT. Front Psychol. 2020;11:2048.PubMedPubMedCentralCrossRef
40.
Jacquemin L, Shekhawat GS, Van de Heyning P, Mertens G, Fransen E, Van Rompaey V, et al. Effects of electrical stimulation in tinnitus patients: conventional versus high-definition tDCS. Neurorehabil Neural Repair. 2018;32(8):714–23.PubMedCrossRef
41.
Newman CW, Jacobson GP, Spitzer JB. Development of the tinnitus handicap inventory. Arch Otolaryngol Head Neck Surg. 1996;122(2):143–8.PubMedCrossRef
42.
Jacquemin L, Mertens G, Van de Heyning P, Vanderveken OM, Topsakal V, De Hertogh W, et al. Sensitivity to change and convergent validity of the Tinnitus Functional Index (TFI) and the Tinnitus Questionnaire (TQ): clinical and research perspectives. Hear Res. 2019;382:107796.PubMedCrossRef
43.
Segarra V, Dueñas L, Torres R, Falla D, Jull G, Lluch E. Inter-and intra-tester reliability of a battery of cervical movement control dysfunction tests. Man Ther. 2015;20(4):570–9.PubMedCrossRef
44.
Rocha CB, Sanchez TG. Efficacy of myofascial trigger point deactivation for tinnitus control. Braz J Otorhinolaryngol. 2012;78(6):21–6.PubMedCrossRef
45.
Teachey WS, Wijtmans EH, Cardarelli F, Levine RA. Tinnitus of myofascial origin. Int Tinnitus J. 2012;17(1):70–3.PubMed
46.
Bosman AJ, Smoorenburg GF. Intelligibility of Dutch CVC syllables and sentences for listeners with normal hearing and with three types of hearing impairment. Audiology. 1995;34(5):260–84.PubMedCrossRef
47.
Khalfa S, Dubal S, Veuillet E, Perez-Diaz F, Jouvent R, Collet L. Psychometric normalization of a hyperacusis questionnaire. ORL J Otorhinolaryngol Relat Spec. 2002;64(6):436–42.PubMedCrossRef
48.
Heller GZ, Manuguerra M, Chow R. How to analyze the visual analogue scale: myths, truths and clinical relevance. Scand J Pain. 2016;13:67–75.PubMedCrossRef
49.
Bolton JE, Humphreys BK. The Bournemouth Questionnaire: a short-form comprehensive outcome measure. II. Psychometric properties in neck pain patients. J Manipulative Physiol Ther. 2002;25(3):141–8.PubMedCrossRef
50.
Gay RE, Madson TJ, Cieslak KR. Comparison of the Neck Disability Index and the Neck Bournemouth Questionnaire in a sample of patients with chronic uncomplicated neck pain. J Manipulative Physiol Ther. 2007;30(4):259–62.PubMedCrossRef
51.
Koo TK, Li MY. A guideline of selecting and reporting intraclass correlation coefficients for reliability research. J Chiropr Med. 2016;15(2):155–63.PubMedPubMedCentralCrossRef
52.
Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, et al. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014;28(1):6–27.PubMedPubMedCentralCrossRef
53.
Gonzalez YM, Schiffman E, Gordon SM, Seago B, Truelove EL, Slade G, et al. Development of a brief and effective temporomandibular disorder pain screening questionnaire: reliability and validity. J Am Dent Assoc. 2011;142(10):1183–91.PubMedPubMedCentralCrossRef
54.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.PubMedCrossRef
55.
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002;52(2):69–77.PubMedCrossRef
56.
Meeus OM, Spaepen M, Ridder DD, Heyning PH. Correlation between hyperacusis measurements in daily ENT practice. Int J Audiol. 2010;49(1):7–13.PubMedCrossRef
57.
Fackrell K, Fearnley C, Hoare DJ, Sereda M. Hyperacusis questionnaire as a tool for measuring hypersensitivity to sound in a tinnitus research population. Biomed Res Int. 2015;2015:290425.PubMedPubMedCentralCrossRef
58.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.PubMedPubMedCentralCrossRef
59.
National Institute for H, Care E. NICE process and methods guides. Guide to the methods of technology appraisal 2013. London: National Institute for Health and Care Excellence (NICE) Copyright © 2013 National Institute for Health and Clinical Excellence, unless otherwise stated. All rights reserved; 2013.
60.
Whitehead SJ, Ali S. Health outcomes in economic evaluation: the QALY and utilities. Br Med Bull. 2010;96:5–21.PubMedCrossRef
61.
Bouckaert N, Gerkens S, Devriese S, Cleemput I. An EQ-5D-5L value set for Belgium – how to value healthrelated quality of life? In: Health Services Research (HSR). Brussels: Belgian Health Care Knowledge Centre (KCE). KCE reports 342; 2021.
62.
Thompson AJ, Turner AJ. A comparison of the EQ-5D-3L and EQ-5D-5L. Pharmacoeconomics. 2020;38(6):575–91.PubMedCrossRef
63.
Bouwmans C, Krol M, Severens H, Koopmanschap M, Brouwer W, Hakkaart-van Roijen L. The iMTA productivity cost questionnaire: a standars instrument for measuring and valuing health-related productivity losses. Value Health. 2015;18(6):753–8.PubMedCrossRef
64.
Schlee W, Schoisswohl S, Staudinger S, Schiller A, Lehner A, Langguth B, et al. Chapter 21 - Towards a unification of treatments and interventions for tinnitus patients: the EU research and innovation action UNITI. In: Schlee W, Langguth B, Kleinjung T, Vanneste S, De Ridder D, editors. Progress in brain research, vol. 260: Elsevier; 2021. p. 441–51.
65.
66.
67.
Fackrell K, Hall DA, Barry JG, Hoare DJ. Psychometric properties of the Tinnitus Functional Index (TFI): assessment in a UK research volunteer population. Hear Res. 2016;335:220–35.PubMedCrossRef
68.
Neyt M, Cleemput I, Sande SV, Thiry N. Belgian guidelines for budget impact analyses. Acta Clin Belg. 2015;70(3):175–80.PubMedCrossRef
69.
Lee J, Lee M, Lim T, Kim T, Kim S, Suh D, et al. Effectiveness of an application-based neck exercise as a pain management tool for office workers with chronic neck pain and functional disability: a pilot randomized trial. Eur J Integr Med. 2017;12:87–92.CrossRef
70.
Lee M, Lee SH, Kim T, Yoo HJ, Kim SH, Suh DW, et al. Feasibility of a smartphone-based exercise program for office workers with neck pain: an individualized approach using a self-classification algorithm. Arch Phys Med Rehabil. 2017;98(1):80–7.PubMedCrossRef
71.
Mehdi M, Dode A, Pryss R, Schlee W, Reichert M, Hauck FJ. Contemporary review of smartphone apps for tinnitus management and treatment. Brain Sci. 2020;10(11):867.PubMedCentralCrossRef
72.
Mehdi M, Stach M, Riha C, Neff P, Dode A, Pryss R, et al. Smartphone and mobile health apps for tinnitus: systematic identification, analysis, and assessment. JMIR Mhealth Uhealth. 2020;8(8):e21767.PubMedPubMedCentralCrossRef
73.
Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, et al. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012;379(9830):1951–9.PubMedCrossRef
74.
Cima RFF, Mazurek B, Haider H, Kikidis D, Lapira A, Noreña A, et al. A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment. Hno. 2019;67(Suppl 1):10–42.PubMedCrossRef
75.
Gialanella B, Comini L, Olivares A, Gelmini E, Ubertini E, Grioni G. Pain, disability and adherence to home exercises in patients with chronic neck pain: long term effects of phone surveillance. A randomized controlled study. Eur J Phys Rehabil Med. 2020;56(1):104–11.PubMedCrossRef
76.
Ylinen J, Häkkinen A, Nykänen M, Kautiainen H, Takala EP. Neck muscle training in the treatment of chronic neck pain: a three-year follow-up study. Eura Medicophys. 2007;43(2):161–9.PubMed
77.
Palazzo C, Klinger E, Dorner V, Kadri A, Thierry O, Boumenir Y, et al. Barriers to home-based exercise program adherence with chronic low back pain: patient expectations regarding new technologies. Ann Phys Rehabil Med. 2016;59(2):107–13.PubMedCrossRef
78.
Pedersen MT, Andersen CH, Zebis MK, Sjøgaard G, Andersen LL. Implementation of specific strength training among industrial laboratory technicians: long-term effects on back, neck and upper extremity pain. BMC Musculoskelet Disord. 2013;14:287.PubMedPubMedCentralCrossRef
79.
Middleton A. Chronic low back pain: patient compliance with physiotherapy advice and exercise, perceived barriers and motivation. Phys Ther Rev. 2004;9(3):153–60.CrossRef
80.
Zebis MK, Andersen CH, Sundstrup E, Pedersen MT, Sjøgaard G, Andersen LL. Time-wise change in neck pain in response to rehabilitation with specific resistance training: implications for exercise prescription. PLoS One. 2014;9(4):e93867.PubMedPubMedCentralCrossRef
Metadata
Title
Cost-effectiveness of a smartphone Application for Tinnitus Treatment (the CATT trial): a study protocol of a randomised controlled trial
Authors
Sara Demoen
Laure Jacquemin
Annick Timmermans
Vincent Van Rompaey
Olivier Vanderveken
Hanne Vermeersch
Iris Joossen
Julie Van Eetvelde
Winfried Schlee
Wim Marneffe
Janis Luyten
Annick Gilles
Sarah Michiels
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Tinnitus
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06378-7

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