The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus

December 3, 2014 updated by: Sarah Michiels, Universiteit Antwerpen

Evaluation of the Effect of Cervical Spine Treatment in Tinnitus Patients

The purpose of this study is to determine whether physiotherapy is effective in the treatment of a group of tinnitus patients with neck complaints.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • University Hospital of Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • severe chronic non-fluctuating subjective cervicogenic somatic tinnitus, which has been stable for at least three months, combined with neck complaints

Exclusion Criteria:

  • objective tinnitus
  • subjective tinnitus with etiologies, such as hearing loss or Meniere's disease, severe depression (> 19 on the Beck depression questionnaire)
  • progressive middle ear pathology
  • intracranial pathology
  • traumatic cervical spine injury
  • tumors
  • cervical spine surgery
  • any cervical spine condition in which physical therapy treatment is contra- indicated
  • received physical therapy treatment directed to the cervical spine in the past 2 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Immediate therapy
Physiotherapy protocol
Other: physiotherapy
PLACEBO_COMPARATOR: waiting list
Physiotherapy protocol
Other: physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Tinnitus Functional Index
Time Frame: pre treatment, post treatment, 6 and 12 months follow up
pre treatment, post treatment, 6 and 12 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Collaborators

University Hospital, Antwerp

Investigators

  • Study Chair: Paul Van de Heyning, PhD, MD, Universiteit Antwerpen
  • Study Chair: Willem De Hertogh, PhD, Universiteit Antwerpen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 13, 2013

First Posted (ESTIMATE)

December 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G850-tinnitus1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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