The CATT Trial: Cost-effectiveness of a Smartphone Application for Tinnitus Treatment

Summary

The twofold aim of this single-blind two-arm 1:1 randomised control trial is to examine if the treatment effect and cost-effectiveness of a smartphone application, designed to increase therapy compliance and provide tinnitus counselling, as part of a blended physiotherapy program, is, as hypothesised, as good as or better in comparison to standard clinical care.

Conditions

• Tinnitus

Interventions

OTHER

Standard Clinical care

The standard care treatment comprises 12 face-to-face individual physiotherapy sessions at a ratio of 1 session a week. Every patient in the control group will be treated in a tailored manner according to their results on the baseline measurements. The multimodal treatment program will consist of exercises to increase strength, endurance and coordination of the cervical spine and shoulder stabilising muscles, exercises to increase mobility and improve posture. In case of jaw complaints stretching exercises of the masticatory muscles are added to the program. In addition, manual mobilisations and manual techniques to decrease muscle tension in neck and jaw muscles can be added to the exercise program if necessary. Patients will receive counselling to learn about their neck/jaw complaints but no tinnitus counselling. Patients will be motivated to perform the exercise program at home on a daily basis. Patients will be evaluated weekly.

DEVICE

Blended physiotherapy program

The experimental group will receive a blended physiotherapy program consisting of six physiotherapy treatments over a period of 12 weeks, meaning one treatment session every two weeks. In addition, a smartphone application will offer the patients a daily exercise program, based upon the standard physiotherapy treatment, and psychological counselling. Before the start of the program, the exercises will be tailored to the area, type and degree of the patient's dysfunctions. During the six physiotherapy treatment sessions patients will (if needed), receive additional manual mobilisations to increase mobility of the neck and/or temporomandibular joints or manual techniques to decrease muscle tension in neck and jaw muscles. Additional counselling on knowledge about neck and jaw pain and advice about good posture and movement habits will also be provided by the physiotherapist during these six treatment sessions.

Sponsors & Collaborators

• Universiteit Antwerpen

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• University of Regensburg

  collaborator OTHER

• Hasselt University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2025-12-01

Completion

2025-12-01

Countries

• Belgium

Study Locations