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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04641156
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.7
• Patients Per Site Per Month: 10.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Tinnitus, Subjective	Other: Exercise Therapy program added to laser therapy	N/A

Study Design

• Study Type: Interventional
• 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: Dec 10, 2018
• Actual Primary Completion Date: Mar 5, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

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

Primary Outcome Measures

1. VAS [8 weeks]

   Numerical estimates of tinnitus severity before and after treatment for both groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Marwa Eid	Cairo		Egypt	2011

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marwa Eid, Professor of physical therapy for surgery, Cairo University
• ClinicalTrials.gov Identifier: NCT04641156
• Other Study ID Numbers: 6688
• First Posted: Nov 23, 2020
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tinnitus

Study Results

No Results Posted as of Feb 1, 2022