Tinnitus, SubjectiveNCT04641156
Effect of Physical Therapy Exercise Program and Low-Level Laser Therapy on the Treatment of Cervicogenic Somatosensory Tinnitus
A study testing Exercise Therapy program added to laser therapy in people with Tinnitus, Subjective, run by Cairo University at 1 site in Egypt.
Trial summary
To determine the effectiveness of adding a physical therapy exercise program to low-level laser therapy on the treatment of chronic tinnitus treatment Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Exercise Therapy program added to laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2018to 1 Apr 2019
- 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 45 to 55 years
- No healthy volunteers
- Adult
Who may be able to join
- Age ranged from 45 to 55 years old both sex
- Unilateral tinnitus
- Stable tinnitus for at least 3 months
- suffering from severe chronic non-fluctuating subjective cervicogenic somatic tinnitus (CST)
Who cannot join
- tinnitus with clear ontological etiologies as perforation of the tympanic membrane
- external otitis media
- conductive hearing loss
- patients with a traumatic cervical spine injury, tumors
- Any history of exposure to ototoxic drugs/substances
- psychotic disorders with auditory hallucination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding Supervised Physical Therapy Exercise Program to Photobiomodulation Therapy in the Treatment of Cervicogenic Somatosensory Tinnitus: A Randomized Controlled Study
To determine the effectiveness of adding a physical therapy exercise program to low-level laser therapy on the treatment of chronic tinnitus treatment
- Conditions
- Tinnitus, Subjective
- Being tested
- Exercise Therapy program added to laser therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Therapy program added to laser therapyOther
a supervised physical therapy exercise program for the neck muscles in the form of manual mobilizations for sternocleidomastoid muscle and upper fibers of trapezius in addition to myofascial trigger point release
| Study group | Role | What they receive |
|---|---|---|
| Low level LASER Therapy | Experimental | Subjects in this group received low-level laser therapy Receives: Other: Exercise Therapy program added to laser therapy |
| Exercise group | Experimental | Subjects in this group received additional planned exercise therapy program Receives: Other: Exercise Therapy program added to laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Numerical estimates of tinnitus severity before and after treatment for both groups
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start10 Dec 2018
- Primary completion5 Mar 2019
- Study completion1 Apr 2019
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641156
- Sponsor's protocol ID
- 6688
- Status last verified
- Jan 2022
- First submitted
- 17 Nov 2020
- Last updated
- 1 Feb 2022
- 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 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Supervised Physical Therapy Exercise Program to Photobiomodulation Therapy in the Treatment of Cervicogenic Somatosensory Tinnitus: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04641156
- Acronym / sponsor ID
- 6688
- Conditions
- Tinnitus, Subjective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 23 Nov 2020 (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.
To determine the effectiveness of adding a physical therapy exercise program to low-level laser therapy on the treatment of chronic tinnitus treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low level LASER Therapy | Experimental | Other: Exercise Therapy program added to laser therapySubjects in this group received low-level laser therapy |
| Exercise group | Experimental | Other: Exercise Therapy program added to laser therapySubjects in this group received additional planned exercise therapy program |
Who may qualify
- Ages
- 45 to 55 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranged from 45 to 55 years old both sex
- Unilateral tinnitus
- Stable tinnitus for at least 3 months
- suffering from severe chronic non-fluctuating subjective cervicogenic somatic tinnitus (CST)
Key exclusion criteria (6 listed)
- tinnitus with clear ontological etiologies as perforation of the tympanic membrane
- external otitis media
- conductive hearing loss
- patients with a traumatic cervical spine injury, tumors
- Any history of exposure to ototoxic drugs/substances
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 |
|---|---|---|
| Exercise Therapy program added to laser therapya supervised physical therapy exercise program for the neck muscles in the form of manual mobilizations for sternocleidomastoid muscle and upper fibers of trapezius in addition to myofascial trigger point release | Other | Exercise group, Low level LASER Therapy |
Primary outcome
VAS
Time frame: 8 weeks
Numerical estimates of tinnitus severity before and after treatment for both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
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 Exercise Therapy program added to laser therapy in people with Tinnitus, Subjective, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 1 Feb 2022. 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VAS (time frame: 8 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 1 Feb 2022.