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Effect 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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

45 Years - 55 Years (Adult)Does not accept healthy volunteers

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

First Posted
November 17, 2020
Last Updated
January 16, 2022
Sponsor
Cairo University
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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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