The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus

Not Applicable

Withdrawn

• Conditions: Tinnitus, Subjective
• Interventions: Other: Cervical physical therapy

• Registration Number: NCT03131674
• Lead Sponsor: Universiteit Antwerpen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct treatment	Cervical physical therapy	-
Delayed treatment	Cervical physical therapy	-

Primary Outcome Measures

Name	Time	Method
Tinnitus Questionnaire	Baseline, 9 weeks, 18 weeks	change in tinnitus distress after treatment and after follow-up

Secondary Outcome Measures

Name	Time	Method
Tinnitus Functional Index	Baseline, 9 weeks, 18 weeks	change in tinnitus severity after treatment and after follow-up
Neck Bournemouth Questionnaire	Baseline, 9 weeks, 18 weeks	change in neck complaints after treatment and after follow-up
Change in Auditory evoked potentials	Baseline, 9 weeks	EEG measurement during auditory task
Change in Manual Rotation test	Baseline, 9 weeks	clinical test
change in adapted Spurling test	baseline, 9 weeks	clinical test
change in presence of active triggerpoints	baseline, 9 weeks	clinical test
change in Craniocervical flexion test	baseline, 9 weeks	clinical test
change in Coordination and strength test of cervical extensor muscles	baseline, 9 weeks	clinical test
change in Speech in noise test	baseline, 9 weeks	audiological test

Trial Locations

Locations (1)

University Hospital of Antwerp; 🇧🇪 Edegem, Antwerp, Belgium