The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus
Evaluation of the Effect of Cervical Spine Treatment in Tinnitus Patients
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2013
CompletedFirst Posted
Study publicly available on registry
December 19, 2013
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 4, 2014
December 1, 2014
3 months
December 9, 2013
December 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Tinnitus Functional Index
pre treatment, post treatment, 6 and 12 months follow up
Study Arms (2)
Immediate therapy
EXPERIMENTALPhysiotherapy protocol
waiting list
PLACEBO COMPARATORPhysiotherapy protocol
Interventions
Eligibility Criteria
You may qualify if:
- severe chronic non-fluctuating subjective cervicogenic somatic tinnitus, which has been stable for at least three months, combined with neck complaints
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universiteit Antwerpenlead
- University Hospital, Antwerpcollaborator
Study Sites (1)
University Hospital of Antwerp
Edegem, Antwerp, 2650, Belgium
Related Publications (2)
Michiels S, Van de Heyning P, Truijen S, Hallemans A, De Hertogh W. Does multi-modal cervical physical therapy improve tinnitus in patients with cervicogenic somatic tinnitus? Man Ther. 2016 Dec;26:125-131. doi: 10.1016/j.math.2016.08.005. Epub 2016 Aug 26.
PMID: 27592038DERIVEDMichiels S, De Hertogh W, Truijen S, Van de Heyning P. Physical therapy treatment in patients suffering from cervicogenic somatic tinnitus: study protocol for a randomized controlled trial. Trials. 2014 Jul 22;15:297. doi: 10.1186/1745-6215-15-297.
PMID: 25056151DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul Van de Heyning, PhD, MD
Universiteit Antwerpen
- STUDY CHAIR
Willem De Hertogh, PhD
Universiteit Antwerpen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistent Rehabilitation Sciences and Physical Therapy
Study Record Dates
First Submitted
December 9, 2013
First Posted
December 19, 2013
Study Start
May 1, 2014
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
December 4, 2014
Record last verified: 2014-12