Physical therapy treatment in patients suffering from cervicogenic somatic tinnitus: study protocol for a randomized controlled trial.

Sarah Michiels,Willem De Hertogh,Paul Van De Heyning,Steven Truijen

doi:10.1186/1745-6215-15-297

Abstract

BackgroundTinnitus occurs in a large part of the general population with prevalences ranging from 10% to 15% in an adult population. One subtype is cervicogenic somatic tinnitus, arising from cervical spine dysfunctions, justifying cervical spine assessment and treatment. This study aims to investigate the effect of a standardized physical therapy treatment, directed to the cervical spine, on tinnitus. Additionally, a second aim is to identify a subgroup within the tinnitus population that benefits from physical therapy treatment.Methods and designThis study is designed as a randomized controlled trial with delayed treatment design. Patients with severe subjective tinnitus (Tinnitus Functional Index (TFI) between 25 and 90 points), in combination with neck complaints (Neck Bournemouth Questionnaire (NBQ) >14 points) will be recruited from the University Hospital of Antwerp.Patients suffering from tinnitus with clear otological etiologies, severe depression, traumatic cervical spine injury, tumors, cervical spine surgery, or conditions in which physical therapy is contra-indicated, will be excluded.After screening for eligibility, baseline data such as TFI, NBQ, and a set of cervical biomechanical and sensorimotor tests will be collected.Patients are randomized in an immediate therapy group and in a group with a delayed start of therapy by 6 weeks.Patients will receive physical therapy with a maximum of 12 sessions of 30 min for a 6-week program. Data from the TFI and NBQ will be collected at baseline (week 0), at the start of therapy (weeks 0 or 6), at the end of therapy (weeks 6 or 12), 6 weeks after therapy (weeks 12 or 18), and 3 months after therapy (weeks 18 or 24). Secondary outcome measures will be collected at baseline and 6 weeks after the therapy (weeks 12 or 18), as the maximal therapy effect on the cervical spine dysfunctions is expected at that moment.DiscussionThis study is the first to investigate the effect of a standardized physical therapy treatment protocol on somatic tinnitus with a prospective comparative delayed design and with blinded evaluator for baseline, end of therapy, and 6 and 12 weeks after therapy.Trial registration12 September 2013, ClinicalTrials.gov: NCT02016313

Highlights

Tinnitus occurs in a large part of the general population with prevalences ranging from 10% to 15% in an adult population
This study is the first to investigate the effect of a standardized physical therapy treatment protocol on somatic tinnitus with a prospective comparative delayed design and with blinded evaluator for baseline, end of therapy, and 6 and 12 weeks after therapy
The aim of this study is to investigate the effect of a standardized physical therapy treatment protocol on several tinnitus and neck-related parameters

Summary

Introduction

Tinnitus occurs in a large part of the general population with prevalences ranging from 10% to 15% in an adult population. This study aims to investigate the effect of a standardized physical therapy treatment, directed to the cervical spine, on tinnitus. Tinnitus is the phantom sensation of sound, in the absence of overt acoustic stimulation [1]. It occurs in 10% to 15% of the adult population [2]. This study will focus on physical therapy treatment for patients suffering from chronic non-fluctuating subjective cervicogenic somatic tinnitus (CST). Other recent studies in humans found that in some patients tinnitus could be evoked or modulated by input from the somatic system, for instance by forceful muscle contractions of the head, neck, and limbs, and pressure on myofacial triggerpoints [7,8,9,10]. Some patients indicate that their tinnitus worsens when performing a combined cervical spine extension and rotation

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