Tinnitus, SubjectiveNCT03131674
The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus
A study testing Cervical physical therapy in people with Tinnitus, Subjective, run by Universiteit Antwerpen at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Cervical physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Tinnitus, Subjective
- Being tested
- Cervical physical therapy
- Keywords
- Somatic tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical physical therapyOther
Patients receive a multimodal cervical physical therapy treatment
| Study group | Role | What they receive |
|---|---|---|
| Direct treatment | Experimental | Not described Receives: Other: Cervical physical therapy |
| Delayed treatment | Experimental | Not described Receives: Other: Cervical physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Questionnaire
change in tinnitus distress after treatment and after follow-up
Measured: Baseline, 9 weeks, 18 weeks
Secondary outcomes (9)
Tinnitus Functional Index
change in tinnitus severity after treatment and after follow-up
Measured: Baseline, 9 weeks, 18 weeks
Neck Bournemouth Questionnaire
change in neck complaints after treatment and after follow-up
Measured: Baseline, 9 weeks, 18 weeks
Change in Auditory evoked potentials
EEG measurement during auditory task
Measured: Baseline, 9 weeks
Change in Manual Rotation test
clinical test
Measured: Baseline, 9 weeks
change in adapted Spurling test
clinical test
Measured: baseline, 9 weeks
change in presence of active triggerpoints
clinical test
Measured: baseline, 9 weeks
change in Craniocervical flexion test
clinical test
Measured: baseline, 9 weeks
change in Coordination and strength test of cervical extensor muscles
clinical test
Measured: baseline, 9 weeks
change in Speech in noise test
audiological test
Measured: baseline, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Ongoing insights required a different approach
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We use a delayed treatment design, where both groups receive the same treatment. One group receives the treatment immediately after the inclusion. The other group receives the treatment after a 9-weeks delay.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Principal investigator, Sarah Michiels, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131674
- Sponsor's protocol ID
- 16/48/512
- Status last verified
- Jun 2019
- First submitted
- 19 Apr 2017
- Last updated
- 13 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus
- ClinicalTrials.gov ID
- NCT03131674
- Acronym / sponsor ID
- 16/48/512
- Conditions
- Tinnitus, Subjective
- Keywords
- Somatic tinnitus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ongoing insights required a different approach
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- We use a delayed treatment design, where both groups receive the same treatment. One group receives the treatment immediately after the inclusion. The other group receives the treatment after a 9-weeks delay.
| Arm | Type | Receives |
|---|---|---|
| Direct treatment | Experimental | Other: Cervical physical therapy |
| Delayed treatment | Experimental | Other: Cervical physical therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical physical therapyPatients receive a multimodal cervical physical therapy treatment | Other | Delayed treatment, Direct treatment |
Primary outcome
Tinnitus Questionnaire
Time frame: Baseline, 9 weeks, 18 weeks
change in tinnitus distress after treatment and after follow-up
9 secondary outcomes
Tinnitus Functional Index
Time frame: Baseline, 9 weeks, 18 weeks
Neck Bournemouth Questionnaire
Time frame: Baseline, 9 weeks, 18 weeks
Change in Auditory evoked potentials
Time frame: Baseline, 9 weeks
Change in Manual Rotation test
Time frame: Baseline, 9 weeks
change in adapted Spurling test
Time frame: baseline, 9 weeks
change in presence of active triggerpoints
Time frame: baseline, 9 weeks
change in Craniocervical flexion test
Time frame: baseline, 9 weeks
change in Coordination and strength test of cervical extensor muscles
Time frame: baseline, 9 weeks
change in Speech in noise test
Time frame: baseline, 9 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical physical therapy in people with Tinnitus, Subjective, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Questionnaire (time frame: Baseline, 9 weeks, 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.