Back to resultsEffect of Physical Therapy Exercise Program and Low-Level Laser Therapy on the Treatment of Cervicogenic Somatosensory Tinnitus
Primary Purpose
Tinnitus, Subjective
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Exercise Therapy program added to laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus, Subjective
Eligibility Criteria
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
Sites / Locations
- Marwa Eid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low level LASER Therapy
Exercise group
Arm Description
Subjects in this group received low-level laser therapy
Subjects in this group received additional planned exercise therapy program
Outcomes
Primary Outcome Measures
VAS
Numerical estimates of tinnitus severity before and after treatment for both groups
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04641156
Brief Title
Effect of Physical Therapy Exercise Program and Low-Level Laser Therapy on the Treatment of Cervicogenic Somatosensory Tinnitus
Official Title
Effect of Adding Supervised Physical Therapy Exercise Program to Photobiomodulation Therapy in the Treatment of Cervicogenic Somatosensory Tinnitus: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
March 5, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To determine the effectiveness of adding a physical therapy exercise program to low-level laser therapy on the treatment of chronic tinnitus treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low level LASER Therapy
Arm Type
Experimental
Arm Description
Subjects in this group received low-level laser therapy
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Subjects in this group received additional planned exercise therapy program
Intervention Type
Other
Intervention Name(s)
Exercise Therapy program added to laser therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
VAS
Description
Numerical estimates of tinnitus severity before and after treatment for both groups
Time Frame
8 weeks
10. Eligibility
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Marwa Eid
City
Cairo
ZIP/Postal Code
2011
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effect of Physical Therapy Exercise Program and Low-Level Laser Therapy on the Treatment of Cervicogenic Somatosensory Tinnitus
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