(1) Objectives: The aim of this study is to evaluate the effect of a single ozone injection in shoulder tendinopathy compared with corticosteroid injections.
(2) Design: The study is clinical trial double-blinded (patients and analyzers) study and the sampling is with random blocks method. The study population are patients referred to physical medicine and rehabilitation clinic at Firoozgar and Rasool Akram hospital which are examined by a physical medicine and rehabilitation specialist and will be will be included in the study after qualifying the inclusion and exclusion criteria and obtaining the informed consent
(3) Setting and conduct: patients will be randomly divided to two groups of fifteen. For randomization we will use randomized blocking method.
(4) Interventions: After providing sterile conditions for injection, in one group, one ml containing 40 mg of triamcinolone and 2 cc of lidocaine and in other group, 8 cc of ozone with a concentration of 15 micrograms and 2 cc of lidocaine, ultrasound-guided injected in the subacromial space with lateral approach. In both groups, physical therapy, including shoulder ROM exercises, posterior capsule stretching and isometric exercises will be taught to patients.
(5) Main outcome measures: Related data to VAS, constant and SPADI questionnaires, pre-treatment, 2 weeks and 2 months after it is evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122424572N4
Registration date:2017-01-27, 1395/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-01-27, 1395/11/08
Registrant information
Name
Arash Babaei-Ghazani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2683
Email address
babaei-ghazani.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-10-16, 1395/07/25
Expected recruitment end date
2017-06-15, 1396/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of single session ultrasound-guided ozone and corticosteroid injection in shoulder tendinopathy
Public title
The comparison of effects of ozone and corticosteroids injection in treatment of shoulder inflammatory diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20 and 80 years; Shoulder tendinopathy as positive result of specific test like Neer & Hawkins test; VAS > 4; The willingness of patients to participate in research projects; The absence history of rotator cuff tear, diabetes, coagulation disorders, fractures, rheumatologic diseases, tumors and infections; Not having shoulder injection in last 3 months; The absence of intraarticular injection contraindications like anticoagulant medications consumption; The absence of corticosteroid and lidocaine injection contraindications such as allergy reaction to these medications and skin infection at the injection site; The absence of ozone injection contraindications such as G6PDD, uncontrolled hyperthyroid, the first 3 months of pregnancy, leukemia.
Exclusion criteria: The willingness of patients to exit from the study at any stage of the project; Non coming patient for follow-up and evaluation during the follow-up study; Daily use of any type of pain medication by patients for the duration of study.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran Universiy of Medical Science
Street address
Medical faculty, Iran University of Medical Sience, Hemmat High way
City
Tehran
Postal code
Approval date
2016-10-16, 1395/07/25
Ethics committee reference number
IR.IUMS.REC 1395.9411524003
Health conditions studied
1
Description of health condition studied
Shoulder tendinopathy
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
The severity of symptoms
Timepoint
Zero, two weeks and two months after
Method of measurement
Visual Analog Scale (VAS)
2
Description
Shoulder Pain and Disability Index
Timepoint
Zero, two weeks and two months after
Method of measurement
SPADI questionnaire
3
Description
The severity of symptoms and functional limitations
Timepoint
Zero, two weeks and two months after
Method of measurement
Constant score questionnaire
Secondary outcomes
1
Description
Side effects
Timepoint
Two weeks and two months after
Method of measurement
Physical examination
Intervention groups
1
Description
Control group: Ultrasound-guided injection of corticosteroid in the subacromial space with lateral approach
Category
Treatment - Other
2
Description
Intervention group: ULtrasound-guided injection of ozone in the subacromial space with lateral approach
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Educational Hospital
Full name of responsible person
Dr Motovalian
Street address
5th floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Motovalian
Street address
5th floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Khabbaz
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran.
City
Tehran
Postal code
Phone
+98 21 8214 1201
Fax
Email
m.sadegh.khabbaz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Arash Babaei
Position
Associate Professor of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
City
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Fax
Email
babaei-ghazani.a@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Khabbaz
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran.
City
Tehran
Postal code
Phone
+98 21 8214 1201
Fax
Email
m.sadegh.khabbaz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)