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The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02016313
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : December 4, 2014
Sponsor:
Collaborator:
University Hospital, Antwerp
Information provided by (Responsible Party):
Sarah Michiels, Universiteit Antwerpen

Tracking Information
First Submitted Date  ICMJE December 9, 2013
First Posted Date  ICMJE December 19, 2013
Last Update Posted Date December 4, 2014
Study Start Date  ICMJE May 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2013)
Change in Tinnitus Functional Index [ Time Frame: pre treatment, post treatment, 6 and 12 months follow up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus
Official Title  ICMJE Evaluation of the Effect of Cervical Spine Treatment in Tinnitus Patients
Brief Summary The purpose of this study is to determine whether physiotherapy is effective in the treatment of a group of tinnitus patients with neck complaints.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE Other: physiotherapy
Study Arms  ICMJE
  • Experimental: Immediate therapy
    Physiotherapy protocol
    Intervention: Other: physiotherapy
  • Placebo Comparator: waiting list
    Physiotherapy protocol
    Intervention: Other: physiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2014)
40
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2013)
50
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02016313
Other Study ID Numbers  ICMJE G850-tinnitus1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sarah Michiels, Universiteit Antwerpen
Study Sponsor  ICMJE Universiteit Antwerpen
Collaborators  ICMJE University Hospital, Antwerp
Investigators  ICMJE
Study Chair: Paul Van de Heyning, PhD, MD Universiteit Antwerpen
Study Chair: Willem De Hertogh, PhD Universiteit Antwerpen
PRS Account Universiteit Antwerpen
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP