NCT03131674WithdrawnNot Applicable
The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Universiteit Antwerpen
- Locations
- 1
- Primary Endpoint
- Tinnitus Questionnaire
Study Overview
Brief Summary
This study investigates the effect of cervical physical therapy on tinnitus annoyance in patients with somatic tinnitus. This study specifically enrolls patients with co-varying tinnitus and neck complaints, with low-pitched tinnitus or patients who's tinnitus can be influenced by neck movements or positions.
These inclusion criteria were chosen, since a prior study showed that these factors were good prognostic indicators for a positive treatment effect.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with subjective tinnitus (Tinnitus Functional Index between 25 and 90 point) in combination with self-reported neck complaints (Neck Bournemouth Questionnaire > 13 points) are included in case one of the following is present:
- •Tinnitus and neck complaints increase and decrease together
- •Tinnitus is low-pitched and increases during inadequate neck postures
Exclusion Criteria
- •Tinnitus related to Ménière's disease, clear otological or neurological causes
- •Serious depression
- •Contra-indications for cervical spine treatment
- •Patient already received cervical physical therapy in the past 2 months
Arms & Interventions
Delayed treatment
Experimental
Intervention: Cervical physical therapy (Other)
Direct treatment
Experimental
Intervention: Cervical physical therapy (Other)
Outcomes
Primary Outcomes
Tinnitus Questionnaire
Time Frame: Baseline, 9 weeks, 18 weeks
change in tinnitus distress after treatment and after follow-up
Secondary Outcomes
- Tinnitus Functional Index(Baseline, 9 weeks, 18 weeks)
- Neck Bournemouth Questionnaire(Baseline, 9 weeks, 18 weeks)
- Change in Auditory evoked potentials(Baseline, 9 weeks)
- Change in Manual Rotation test(Baseline, 9 weeks)
- change in adapted Spurling test(baseline, 9 weeks)
- change in presence of active triggerpoints(baseline, 9 weeks)
- change in Craniocervical flexion test(baseline, 9 weeks)
- change in Coordination and strength test of cervical extensor muscles(baseline, 9 weeks)
- change in Speech in noise test(baseline, 9 weeks)
Investigators
Sarah Michiels
Post-doctoral researcher
Universiteit Antwerpen
Study Sites (1)
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