Conservative therapy for the treatment of patients with somatic tinnitus attributed to temporomandibular dysfunction: Study protocol of a randomised controlled trial

Background: Tinnitus is a highly prevalent symptom affecting 10-15% of the adult population. It often affects patient quality of life and frequently causes distress. When subjective tinnitus can be elicited by the somatosensory system of the cervical spine or temporomandibular area it is termed somatic tinnitus. The first aim of the current study is to investigate the effect of the best evidence conservative temporomandibular disorder (TMD) treatment on tinnitus in patients with co-existence of tinnitus and TMD or oral parafunctions compared to no treatment. The second aim is to identify a subgroup of patients with tinnitus that benefits from the conservative temporomandibular joint treatment. Methods and design: This study is a randomised controlled trial with a delayed treatment design. Patients with a TMD (TMD pain screener ≥ 3 points) or oral parafunctions (such as clenching and bruxism), who are suffering from moderate to severe subjective tinnitus (Tinnitus Functional Index (TFI) between 25 and 90 points), will be recruited from the tertiary tinnitus clinic of the University Hospital of Antwerp, Edegem, Belgium. Patients will be excluded in case of clear otological or neurological causes of the tinnitus, progressive middle ear pathology, intracranial pathology, traumatic cervical spine or temporomandibular injury in the past 6 months, severe depression as diagnosed by a psychologist, tumours, previous surgery in the orofacial area, substance abuse that may affect the outcome measures, any contra-indication for physical therapy treatment directed to the orofacial area or when they received TMD treatment in the past 2 months. After screening for eligibility, baseline data among which scores on the TFI, tinnitus questionnaire (TQ), mean tinnitus loudness as measured with visual analogue scale (VAS), TMD pain screener, and a set of temporomandibular joint tests will be collected. Patients will be randomised in an early-start group and in a delayed-start group of therapy by 9 weeks. Patients will receive conservative TMD treatment with a maximum of 18 sessions within 9 weeks. At baseline (week 0), at the start of therapy (weeks 0 or 9), 9 weeks after therapy (weeks 9 or 18), and at follow-up (weeks 18 or 27) data from the TFI, TQ, VAS mean tinnitus loudness and the TMD pain screener will be collected. Discussion: Herein, we aim to improve the quality of care for patients with tinnitus attributed to TMD or oral parafunctions. By evaluating the effect of state-of-the-art TMD treatment on tinnitus complaints, we can investigate the usefulness of TMD treatment in patients with somatic tinnitus. Trial registration: 3 July 2017, version 1 of the protocol, ClinicalTrials.gov NCT03209297