NCT04641156

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

November 17, 2020

Last Update Submit

January 16, 2022

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (1)

  • VAS

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

    8 weeks

Study Arms (2)

Low level LASER Therapy

EXPERIMENTAL

Subjects in this group received low-level laser therapy

Other: Exercise Therapy program added to laser therapy

Exercise group

EXPERIMENTAL

Subjects in this group received additional planned exercise therapy program

Other: Exercise Therapy program added to laser therapy

Interventions

Exercise Therapy program added to laser therapyOTHER

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

Exercise groupLow level LASER Therapy

Eligibility Criteria

Age45 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of physical therapy for surgery

Study Record Dates

First Submitted

November 17, 2020

First Posted

November 23, 2020

Study Start

December 10, 2018

Primary Completion

March 5, 2019

Study Completion

April 1, 2019

Last Updated

February 1, 2022

Record last verified: 2022-01

Locations

EG(1)