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Comparison of local ozone injection vs corticosteroid injection in the treatment of shoulder adhesive capsulitis

Protocol summary

Study aim
The aim of this study is to compare the effectiveness of two methods of intra articular injection of Ozone and Corticosteroid in improving pain and function in patients with adhesive capsulitis of the shoulder.
Design
Phase III, randomized, double-blind, parallel-group clinical trial with two week and eight week post injection follow up on 40 patients. Randomization was done through the use of closed envelopes (Envelope A: for Corticosteroid injection and Envelope B: for Ozone injection).
Settings and conduct
Patients with adhesive capsulitis of the shoulder referred to Imam Reza and Shahid Madani Medical Center of Tabriz, who were randomly divided into two groups using the closed envelope method.
Participants/Inclusion and exclusion criteria
The criteria for entering this study: age more than 20 years, diagnosis of shoulder adhesive capsulitis based on shoulder specialized tests such as checking active and passive range of motion, pain intensity based on visual analog scale greater than or equal to 4, consent to enter the study. Exclusion criteria: drug addiction, history of coagulation disorders, rheumatological diseases, history of intra articular injection during the previous three months, use of anticoagulants, hypersensitivity reaction to lidocaine, neck radiculopathy, cellulitis and skin infection at the site Intra articular injection, contraindications of ozone therapy (known cases of glucose 6 phosphate dehydrogenase deficiency, uncontrolled hyperthyroidism, pregnancy and leukemia).
Intervention groups
Two groups including blind ozone and corticosteroid injection groups
Main outcome variables
Pain intensity, degree of functional disability and shoulder range of motion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100127003217N14
Registration date: 2022-11-09, 1401/08/18
Registration timing: prospective

Last update: 2022-11-09, 1401/08/18
Update count: 0
Registration date
2022-11-09, 1401/08/18
Registrant information
Name
Fariba Eslamian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3967
Email address
eslamiyanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of local ozone injection vs corticosteroid injection in the treatment of shoulder adhesive capsulitis
Public title
Comparison of the effects of local ozone and corticosteroid injection in the treatment of adhesive capsulitis of the shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 20 years Diagnosis of shoulder adhesive capsulitis based on specialized shoulder tests such as active and passive ROM Pain intensity based on VAS criteria is greater than or equal to 4 Consent to enter the study
Exclusion criteria:
Drug addiction History of coagulation disorders, rheumatological diseases, History of intra-articular injection during the previous three months Use of anticoagulants Hypersensitivity reaction to lidocaine Neck radiculopathy Cellulitis and skin infection at the site of intra-articular injection Contraindications for ozone therapy include known cases of G6PD deficiency, uncontrolled hyperthyroidism, pregnancy, and leukemia
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
A box containing 40 sealed envelopes is selected and group A paper is placed inside 20 envelopes and group B paper is placed inside 20 envelopes. This box is placed in front of patients and one envelope is chosen by each patient. In this way, the patients are completely unaware of the selected group and are randomly assigned to group A (Ozone injection) or group B (Cortone injection).
Blinding (investigator's opinion)
Double blinded
Blinding description
Away from the patient's eyes, the desired injectable substance will be prepared in the syringe and the syringes will be covered with an aluminum sheet so that the person does not know the type of injected substance.Due to the different nature of ozone (gas), during the injection, there is a possibility that the injecting person will understand the nature of this injected substance.The statistical analysis person is also kept blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Daneshgah Ave, executive field of Tabriz University of Medical Sciences, Vice-Chancellor for research of Tabriz University of Medical Sciences, University Ethics Committee
City
Tabriz
Province
East Azarbaijan
Postal code
5123698741
Approval date
2022-10-03, 1401/07/11
Ethics committee reference number
IR.TBZMED.REC.1401.569

Health conditions studied

1

Description of health condition studied
Adhesive capsulitis of the shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder

Primary outcomes

1

Description
Pain intensity
Timepoint
Before the intervention, 2 weeks and 8 weeks after the treatment
Method of measurement
Visual analogue scale (VAS)

Secondary outcomes

1

Description
Shoulder joint range of motion
Timepoint
Before the intervention, 2 weeks and 8 weeks after the treatment
Method of measurement
Goniometry

2

Description
Functional disability of shoulder-related activities
Timepoint
Before the intervention, 2 weeks and 8 weeks after the treatment
Method of measurement
Shoulder Pain and Disability Index (SPADI)

Intervention groups

1

Description
Intervention group:The first intervention group: Ozone with a concentration of 15 micro-gram in the shoulder joint area, blindly and with a posterior approach
Category
Treatment - Other

2

Description
Intervention group: The second intervention group: Methylprednisolone acetate (40 mg) in the shoulder joint area with a posterior approach and blindly
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Fariba Eslamiyan
Street address
Department of physical medicine and rehabilitation, Emam Reza hospital, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5698745213
Phone
+98 41 3336 1928
Email
eslamiyanf@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr Mohammad Samiei
Street address
The end of Golgasht St, Daneshgah St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Eslamiyan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 3967
Email
eslamiyanf@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Eslamiyan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital, The end of Golgasht St, Daneshgah St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 3967
Email
Eslamiyanf@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rezvan Ghaed Durbash
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital, The end of Golgasht St, Daneshgah St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 3967
Email
rezvan.ghaed@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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