The effect of local injection of ozone, corticosteroid and prothorectropy under ultrasound guidance in the treatment of inflammation of shoulder tendons: a randomized, prospective, multicentre double blind clinical trial with positive control group
The effect of Sono-guided Oxygen-ozone/ corticosteroid and prothorectropy local injection in the treatment of Shoulder tendonitis
Design
Phase 3, multi-center, double blind randomized controlled clinical trial, with parallel group design. The study will be done on 75 patients (25 in each group), and follow-up will be done one week and two months after injection
Settings and conduct
Department of Physical Medicine and Rehabilitation of Shohada Hospital and Imam Reza Hospital affiliated to Tabriz University of Medical Sciences and Physiotherapy and Rehabilitation Physics Department of Rasoul Akram Medical Center affiliated to Iran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: Tendinopathy in patients with positive one of the shoulder tests including Neer test or Hawkins test, VAS greater than 4, Patient's desire to attend the research project. Exclusion criteria: rotator cuff tear, diabetes, coagulation disorders, fracture, hematological diseases, tumors and infection,history of Injection in the shoulder joint in the last 3 months, Frozen Shoulder, Presence of c6-c5 Concomitant radiculopathy.
Visual Analogue Scale (VAS); shoulder pain and disability index (SPADI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151017024572N17
Registration date:2018-07-12, 1397/04/21
Registration timing:registered_while_recruiting
Last update:2018-07-12, 1397/04/21
Update count:2
Registration date
2018-07-12, 1397/04/21
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
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local injection of ozone, corticosteroid and prothorectropy under ultrasound guidance in the treatment of inflammation of shoulder tendons: a randomized, prospective, multicentre double blind clinical trial with positive control group
Public title
The effect of local injection of ozone, corticosteroid and prothorectropy under ultrasound guidance in the treatment of inflammation of shoulder tendons
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of tandinopathy in patients as a positive one in a special shoulder test, including: Neer test, Hawkins test
Visual Analog Scale (VAS) above 4
Patient's desire to attend research project
Exclusion criteria:
Existence of a history and examination of rotator cuff tears, diabetes, coagulation disorders, fractures, rheumatologic diseases, tumors and infection
Receiving injection in the shoulder joint in the last 3 months
Frozen Shoulder
Presence of c6-c5 synchronous radiculopathy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method for randomization will be used and individuals (patients) will form random units. A random sequence will be generated using RAS software. A central randomization method will be used to conceal random allocation. The random sequence will be created by the statistician and will be available to her. The doctor will be connected to the statistician by telephone or text message and will ask him or her about the random allocation of the participant to the specific group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the patient, the doctor will prepare the injection material in the syringe, and will cover the syringes with an aluminum sheet to avoid being aware of the type of injection. It should be noted that dilution of corticosteroid and normal salin will be done to equalize the volume of all three injectable solutions.
Patients in each group will be evaluated by a physical medicine and rehabilitation specialist, who is not aware of the type of injection, before the injection, one week after the injection and two months after the injection.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.IUMS.REC 1396.30322
Health conditions studied
1
Description of health condition studied
Inflammation of the shoulder tendons
ICD-10 code
G59
ICD-10 code description
Mononeuropathy in diseases classified elsewhere
Primary outcomes
1
Description
Pain score based on Visual Analogue Scale
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
Visual Analog Scale (VAS)
2
Description
Shoulder pain and disability
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
Shoulder pain and disability index (SPADI)
Secondary outcomes
1
Description
Clinical Global Impression
Timepoint
Before injection, 1 weeks and 8 weeks after injection
Method of measurement
Clinical Global Impression Questionnaire
2
Description
Patient Global Impression of Improvement
Timepoint
Before injection, 1 weeks and 8 weeks after injection
Method of measurement
Patient Global Impression of Improvement Questionnaire
3
Description
shoulder rang of motiom
Timepoint
Before injection, 1 weeks and 8 weeks after injection
Method of measurement
goniometer
4
Description
synovial thickness
Timepoint
Before injection, 1 weeks and 8 weeks after injection
Method of measurement
sonography
5
Description
Partial tearing
Timepoint
Before injection, 1 weeks and 8 weeks after injection
Method of measurement
sonography
6
Description
Liquid Thickness
Timepoint
Before injection, 1 weeks and 8 weeks after injection
Method of measurement
sonography
Intervention groups
1
Description
Intervention group (ozone therapy): 5cc ozone 20μg / L, in subacromial space with lateral aperture under ultrasound guidance.
Category
Treatment - Drugs
2
Description
Intervention group (porlotherapy): 5cc dextrose 50%, in subacromial space with lateral aperture under ultrasound guidance.
Category
Treatment - Drugs
3
Description
Control group (corticosteroid therapy ): 1cc triamcinolone 40mg + 1cc normal slain, in subacromial space with lateral aperture under ultrasound guidance.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Physical Medicine and Rehabilitation of Rasoul-e-Akram Medical Education Center affili
Full name of responsible person
Arash babaee
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
babaei-ghazani.a@iums.ac.ir
2
Recruitment center
Name of recruitment center
Shohada Medical Research and Training Hospital,Tabriz University of Medical Sciences
Full name of responsible person
Dr. Babak Kolahi
Street address
Imam Reza hospital, University Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 3161
Email
dr.kolahi@gmail.com
3
Recruitment center
Name of recruitment center
Physical medicine and rehabilitation research center of Shohada Hospital affiliated to Tabriz Univer
Full name of responsible person
Dr. Bina Eftekharsaadat
Street address
Shohada hospital, GolshahrAve.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 21 3336 3161
Email
binasadat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bina Eftekhar sadat
Street address
Gulgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 3161
Email
binasadat@yahoo.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
70
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
2
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
دکتر سید کاظم ملکوتی
Street address
مرکز تحقیقات بیماریهای عصبی، عضلانی و اسکلتی، دانشکده طب فیزیکی و توانبخشی، دانشگاه علوم پزشکی ایران
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 41 1331 1147
Email
rashbabaie@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
30
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
Iran University of Medical Sciences
Full name of responsible person
Arash Babaie
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical medicine and rehabilitation ward, Firoozgar Hospital, Behafarin Avenue, Valiasr Square, Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
arashbabaie@gmail.com
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
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
City
Tehran
Province
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
Dr. Arash Babaei
Position
Associate Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Fax
Email
babaei-ghazani.a@iums.ac.ir
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available