Comparison of the effect of ultrasound-guided topical ozone injection, corticosteroid injection and prolotherapy on pain intensity in patients with coccydynia: A prospective, double-blind, multicenter randomized clinical trial
To compare effect of ultrasound guided Corticosteroid, Ozone and Dextrose injection in patients with coccydynia .
Design
Randomised, multicenter, double blinded, three arm parallel group clinical trial. RAS software will be used for randomization.
Settings and conduct
Phase 3 multi center, randomized, double-blind clinical trial, with parallel groups with follow-up one week and two months after injection in four different treatment centers of Shohada and Imam Reza hospitals of Tabriz University of Medical Sciences, Rasoul Akram Hospital of Iran University of Medical Sciences and Iran Neuromuscular Center will be performed. Before injection, 2 cc of lidocaine 2% is used for local anesthesia of the skin and underlying tissues in all groups. Ozone is then injected under sterile conditions in a group of patients. The injection is with a 25 Gage needle and in the other two groups corticosteroids or dextrose will be injected under sterile conditions. For all patients, the injection will be performed under ultrasound guidance and using needle number 27 after aspiration and ensuring the correct placement of the needle.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of coccydynia; age of 18-65 years; pain score ranging from 1 to 10 in visual analogue scale.
Exclusion criteria: Tumors of the cauda equina; pelvic surgeries; Herniation of the lumbosacral disc.
Intervention groups
Intervention group 1:Ultrasound guided injection of Ozone;
Intervention group 2:Ultrasound guided injection of corticosteroid;
Intervention group 3:Ultrasound guided injection of Dextrose.
Main outcome variables
Pain intensity; overall recovery rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100827004641N17
Registration date:2020-08-26, 1399/06/05
Registration timing:registered_while_recruiting
Last update:2020-08-26, 1399/06/05
Update count:0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
Bina Eftekharsadat
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 3193
Email address
binasadat@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-18, 1398/10/28
Expected recruitment end date
2021-01-17, 1399/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ultrasound-guided topical ozone injection, corticosteroid injection and prolotherapy on pain intensity in patients with coccydynia: A prospective, double-blind, multicenter randomized clinical trial
Public title
Comparison of the effect of ozone, corticosteroid and prolotherapy in coccydynia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of coccydynia
Age of 18-65 years
Pain score ranging from 1 to 10 in visual analogue scale
Exclusion criteria:
Tumors of the cauda equina
Pelvic surgery
Herniation of the lumbosacral disc
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly divided into three treatment groups using a table of random numbers and a centralized randomization method. In order to execute the randomization process to create a random sequence and to perform the random allocation process we will use RAS software which will be created by a statistician. Two hours before the patient's visit for injection, the person responsible for injection will contact the statistician by phone or text message and will ask her about the random assignment of the participant to a specific group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The injection material is prepared in the syringe without informing the patient and the syringes will be covered with an aluminum foil so that the participant does not know the type of injection material. Patients will be prohibited from receiving any NSAIDs or analgesics for a 15-day wash-out period prior to enrollment and intervention. Due to the different nature of ozone (gas), during the injection, there is a possibility that the injector will acknowledge the nature of this medical substance. The person responsible for outcome measures and the person responsible for the statistical analysis are also kept blind.
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
Iran University of Medical Sciences; next to Milad Tower; Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.IUMS.REC.1398.1016
Health conditions studied
1
Description of health condition studied
Coccydynia
ICD-10 code
M53.3
ICD-10 code description
Sacrococcygeal disorders, not elsewhere classified
Primary outcomes
1
Description
Pain intensity
Timepoint
Evaluating the visual analogue scale at the beginning of the study (before intervention) and 7 and 60 days after injection
Method of measurement
Visual analogue Scale
2
Description
Overall recovery rate
Timepoint
Evaluating the overall recovery rate at 7 and 60 days after injection
Method of measurement
Patient Global Impression of Improvement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group one: Ozone (O2-O3), 12 micro-gram, one time ultrasound guided injection inside the sacrococcygeal area
Category
Treatment - Drugs
2
Description
Intervention group two: Corticosteroid, 40 mg Methylprednisolone, one time ultrasound guided injection inside the sacrococcygeal area
Category
Treatment - Drugs
3
Description
Intervention group three: Prolotherapy (Dextrose 20 %), one time ultrasound guided injection inside the sacrococcygeal area
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Medical Research & Training Hospital
Full name of responsible person
Bina Eftekharsadat
Street address
No 692; Golshar street; Ellgoli road
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3389 3337
Email
shohadahospital@tbzmed.ac.ir
2
Recruitment center
Name of recruitment center
Imam Reza Medical Research & Training Hospital
Full name of responsible person
Bina Eftekharsadat
Street address
Imam Reza Medical Research & Training Hospita; Golgasht avenue; Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir
3
Recruitment center
Name of recruitment center
Rasool Akram Medical Research & Training Hospital
Full name of responsible person
Bina Eftekharsadat
Street address
Hazrate Rasoole Akram Hospital, Niayesh blvd, Satarkhan street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 1643
Email
imamreza@tbzmed.ac.ir
4
Recruitment center
Name of recruitment center
Iran Neuromuscular Center
Full name of responsible person
Bina Eftekhsadat
Street address
Hazrate Rasoole Akram Hospital, Niayesh blvd, Satarkhan street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 1643
Email
imamreza@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bina Eftekharsadat
Street address
Imam Reza Medical Research & Training Hospita; Golgasht avenue; Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 1134
Email
pmrrc@tbzmed.ac.ir
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
Bina Eftekharsadat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Medical Research & Training Hospita; Golgasht avenue; Daneshgah street