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

Tinnitus, Subjective Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03131674
• Other study ID #: 16/48/512
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2019
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Other:
• Cervical physical therapy
Patients receive a multimodal cervical physical therapy treatment

Locations

Country	Name	City	State
Belgium	University Hospital of Antwerp	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

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