To investigate the effects of osteopathic manipulation on tinnitus severity and pain in patients with somatic tinnitus.
Design
A randomized clinical trial, concealed, blinded, with a parallel control group, 80 patients, between March 2021 and December 2021, and followed for 9 months.
Settings and conduct
ENT Department
University of Lahore Teaching Hospital, Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients with somatic tinnitus; Aged18-60 years; Both genders.
Exclusion Criteria:
history of ear surgery; history of cervical surgery; hypertension; history of head trauma; history of non-steroidal anti-inflammatory drugs usage; arteriosclerosis; arthritis; diabetes mellitus; continuous noise exposure.
Intervention groups
Intervention group: osteopathic manipulation along with traditional physiotherapy.
Control group: traditional physiotherapy only.
Main outcome variables
Tinnitus severity; Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201201049564N1
Registration date:2021-09-09, 1400/06/18
Registration timing:registered_while_recruiting
Last update:2021-09-09, 1400/06/18
Update count:0
Registration date
2021-09-09, 1400/06/18
Registrant information
Name
Anam Saeed
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 42 35451125
Email address
anasaeed63@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-10-30, 1400/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects Of Osteopathic Manipulation On Clinical Outcomes In Patients With Somatic Tinnitus: A Randomized Controlled Trial
Public title
Effects Of Osteopathic Manipulation On Clinical Outcomes In Patients With Somatic Tinnitus: A Randomized Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with somatic tinnitus
Aged18-60 years
Both genders.
Exclusion criteria:
History of any ear surgery
History of cervical surgery
Hypertension
History of head trauma
History of non-steroidal anti-inflammatory drugs usage
Arteriosclerosis
Arthritis
Diabetes mellitus
History of continuous noise exposure
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 66 participants was recruited into the study. The subjects were randomly assigned into two groups A or B (each containing 33 subjects) according to their selection by lottery method. There were 33 cards marked with group-A and 33 with group-B inside a box. Each participant was requested to randomly pick a card from the box. Slips that were picked by the participants, were not put back in the box.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor was unaware of the treatment given to the participant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Lahore
Street address
University Of Lahore, Defense road near buhbatian chowk, Lahore
City
Lahore
Postal code
54000
Approval date
2020-12-01, 1399/09/11
Ethics committee reference number
IRB-UOL-FAHS/791/2020
Health conditions studied
1
Description of health condition studied
Somatic Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
Severity of tinnitus
Timepoint
baseline, 4th week, 8th week
Method of measurement
Tinnitus Handicap inventory
2
Description
Pain
Timepoint
Baseline, 4th week, 8th week
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
osteopathic manipulation (includes soft tissue mobilization/stretching of upper trapezius, infraspinatus, splenius capitis, splenius cervicis, sternocleidomastoid, METS of cervical, high velocity, low amplitude thrust of cervical) for the somatic tinnitus to reduce the pain and tinnitus severity. the treatment was given on alternate days for the period of 8 weeks.
Category
Treatment - Other
2
Description
Control group: traditional physiotherapy was given with TENS for 10 min at 50 width and rate of 70 hz, Heating pad for 10 min along with tissue mobilization/stretching of upper trapezius, infraspinatus, splenius capitis, splenius cervicis, sternocleidomastoid, METS of cervical, high velocity, low amplitude thrust of cervical
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT Department. University of Lahore Teaching Hospital, Lahore
Full name of responsible person
Dr. Zahid
Street address
University of Lahore Teaching Hospital, University Road Lahore
City
Lahore
Postal code
54000
Phone
+92 42 32560865
Email
info@uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Anam Saeed
Street address
105-B, Block A-1 P&D society Canal road Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35451125
Email
anasaeed63@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
self-funded
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Anam Saeed
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
105-B, Block A-1 P&D society Canal road Lahore
City
Lahore
Province
Punajb
Postal code
54000
Phone
+92 321 8191607
Email
anasaeed63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Anam Saeed
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
105-B, Block A-1 P&D society Canal road Lahore
City
Lahore
Province
Punajb
Postal code
54000
Phone
+92 321 8191607
Email
anasaeed63@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Anam Saeed
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
105-B, Block A-1 P&D society Canal road Lahore
City
Lahore
Province
Punajb
Postal code
54000
Phone
+92 321 8191607
Email
anasaeed63@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD