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Effect of Physical Therapy Exercise Program and Low-Level Laser Therapy on the Treatment of Cervicogenic Somatosensory Tinnitus

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ClinicalTrials.gov Identifier: NCT04641156
Recruitment Status : Completed
First Posted : November 23, 2020
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Marwa Eid, Cairo University

Study Description
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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

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Other: Exercise Therapy program added to laser therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Adding Supervised Physical Therapy Exercise Program to Photobiomodulation Therapy in the Treatment of Cervicogenic Somatosensory Tinnitus: A Randomized Controlled Study
Actual Study Start Date : December 10, 2018
Actual Primary Completion Date : March 5, 2019
Actual Study Completion Date : April 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Low level LASER Therapy
Subjects in this group received low-level laser therapy
 Other: Exercise Therapy program added to 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
 Other: Exercise Therapy program added to 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


Outcome Measures
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Primary Outcome Measures :
  1. VAS [ Time Frame: 8 weeks ]
    Numerical estimates of tinnitus severity before and after treatment for both groups


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641156


Locations
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Egypt
Marwa Eid
Cairo, Egypt, 2011
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Marwa Eid, Professor of physical therapy for surgery, Cairo University
ClinicalTrials.gov Identifier: NCT04641156    
Other Study ID Numbers: 6688
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases