- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04641156
Effect of Physical Therapy Exercise Program and Low-Level Laser Therapy on the Treatment of Cervicogenic Somatosensory Tinnitus
January 16, 2022 updated by: Marwa Eid, Cairo University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 2011
- Marwa Eid
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
43 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low level LASER Therapy
Subjects in this group received low-level laser therapy
|
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
|
Experimental: Exercise group
Subjects in this group received additional planned exercise therapy program
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS
Time Frame: 8 weeks
|
Numerical estimates of tinnitus severity before and after treatment for both groups
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2018
Primary Completion (Actual)
March 5, 2019
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
November 17, 2020
First Submitted That Met QC Criteria
November 20, 2020
First Posted (Actual)
November 23, 2020
Study Record Updates
Last Update Posted (Actual)
February 1, 2022
Last Update Submitted That Met QC Criteria
January 16, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6688
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tinnitus, Subjective
-
State University of New York at BuffaloUniversity at BuffaloCompletedTinnitus, Subjective | Tinnitus | Noise Induced Tinnitus | Tinnitus, Objective | Tinnitus Aggravated | Tinnitus, Pulsatile | Tinnitus, Spontaneous Oto-Acoustic Emission | Tinnitus, Clicking | Tinnitus, Tensor Tympani InducedUnited States
-
Philipps University Marburg Medical CenterLinkoeping University; Eriksholm Research Centre; University Hospital of Gießen...CompletedTinnitus | Subjective Tinnitus | Chronic TinnitusGermany
-
Cairo UniversityRecruiting
-
University of ZurichRecruitingTinnitus, Subjective | TinnitusSwitzerland
-
Eye & ENT Hospital of Fudan UniversityNot yet recruiting
-
University of Illinois at Urbana-ChampaignGN Hearing A/SActive, not recruitingTinnitus, SubjectiveUnited States
-
University of ZurichCompletedTinnitus, SubjectiveGermany, Switzerland
-
Universiteit AntwerpenUniversity Hospital, AntwerpWithdrawnTinnitus, SubjectiveBelgium
-
Washington University School of MedicineNational Institute on Deafness and Other Communication Disorders (NIDCD)Completed
-
Merz Pharmaceuticals GmbHTerminatedSubjective TinnitusUnited States, United Kingdom, Poland, Austria, Belgium, Brazil, Czech Republic, France, Germany, Mexico, Netherlands, Portugal, South Africa, Spain
Clinical Trials on Exercise Therapy program added to laser therapy
-
Pamukkale UniversityRecruitingTelerehabilitation | Knee Arthroplasty, TotalTurkey
-
Cairo UniversityKing Khalid UniversityRecruitingChronic Nonspecific Low-back PainEgypt
-
Gaziler Physical Medicine and Rehabilitation Education...Completed
-
Cairo UniversityRecruiting
-
Trakya UniversityNot yet recruiting
-
Cairo UniversityRecruiting
-
Munzur UniversityIstanbul University - Cerrahpasa (IUC)CompletedMyofascial Trigger Point Pain | Chronic Pelvic Pain SyndromeTurkey
-
Umm Al-Qura UniversityCompletedOsteopenia or OsteoporosisSaudi Arabia
-
Cairo UniversityKing Khalid UniversityRecruitingChronic Nonspecific Low-back PainEgypt
-
Dalian Second People's HospitalCompletedAdolescent Idiopathic Scoliosis | Laser AcupunctureChina