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Sono-guided Prolotherapy; Oxygen-ozone; corticosteroid therapy for the treatment of musculoskeletal Pain in physical and rehabilitation medicine: Interventional pain management for Piriformis: AProspective, randomized, double-blind, Positive control, Multicenter Clinical Trial

Protocol summary

Study aim
Comparison of the effects of topical ozone and corticosteroid injections and prolotherapy in reducing pain due to various musculoskeletal disorders such as preformis, a model for reducing pain
Design
This is a multicenter double-blind randomized clinical trial (patient and analyst)
Settings and conduct
The study was performed by four specialists in physical medicine and rehabilitation in four medical 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. In each group, after providing sterile conditions with Povidone-Iodine solution, anesthesia is performed locally with 1 cc of 2% lidocaine and 22 gage needle. 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 1. Pain and the presence of trigger points at least 2 months ago. 2. VAS score up 4. Exclusion criteria 1. Existence of radiculopathy 2. Appropriate imaging 3. Abscess, fibrosis 4. Existence of a history of physiotherapy in the last 2 months 5. The presence of trigger points in the gluteus medius muscle 6. Coagulation disorders 7. Pregnancy
Intervention groups
the first group receive prolotherapy and the second group receive corticosteroids and the group receive ozone treatment.
Main outcome variables
Treatment, age, sex, occupation, level of education, weight, height, duration of illness, marked trauma, pain, income level, overall clinical perception, overall patient perceptions, VAS, SF36, ROM, electrodiagnostic findings

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100827004641N15
Registration date: 2020-08-04, 1399/05/14
Registration timing: registered_while_recruiting

Last update: 2020-08-04, 1399/05/14
Update count: 0
Registration date
2020-08-04, 1399/05/14
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
Sono-guided Prolotherapy; Oxygen-ozone; corticosteroid therapy for the treatment of musculoskeletal Pain in physical and rehabilitation medicine: Interventional pain management for Piriformis: AProspective, randomized, double-blind, Positive control, Multicenter Clinical Trial
Public title
Sono-guided Prolotherapy/ Oxygen-ozone/ corticosteroid therapy for the treatment of musculoskeletal Pain in physical and rehabilitation medicine: Interventional pain management for Piriformis: AProspective, randomized, double-blind, Positive control, Multicenter Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain and the presence of trigger points in the preformis area for at least 2 months VAS score up 4
Exclusion criteria:
Existence of radiculopathy based on clinical examination Appropriate imaging if needed Abscess, fibrosis or any skin infection at the injection sitedisorders7. Pregnancy Existence of a history of physiotherapy or injections in the last 2 months The presence of trigger points in the gluteus medius muscle, which is adjacent to the piriformis Coagulation
Age
From 46 years old to 46 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
A block randomization method will be used to allocate participants to the groups with a 1:1:1 allocation using random allocation software (RAS) with block sizes of 3 and 6. Similar sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package
Blinding (investigator's opinion)
Triple blinded
Blinding description
Away from the patient's eye, prepare the injection material in the syringe and cover the syringes with an aluminum foil so that the person does not know the type of injection material.
Placebo
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
3rd Floor, Central Building, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5154613614
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.IUMS.REC.1398.1094

Health conditions studied

1

Description of health condition studied
Piriformis syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Local injection of ozone
Timepoint
Baseline
Method of measurement
Specific indexes and sonographic findings

2

Description
Corticosteroids
Timepoint
Before injection, one week later and two months after injection
Method of measurement
Specific indexes and sonographic findings

3

Description
Prolotherapy
Timepoint
Baseline
Method of measurement
Specific indexes and sonographic findings

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A
Category
Treatment - Drugs

2

Description
Intervention group B:
Category
Treatment - Drugs

3

Description
Intervention group c:
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Shohda Educational and Medical Center
Full name of responsible person
Bina Eftekhasadat
Street address
Hospitl shohada, ST golshahr, ST ell goli
City
Tabriz
Province
East Azarbaijan
Postal code
692
Phone
+98 41 3389 3336
Fax
Email
shohadahospital@tbzmed.ac.ir

2

Recruitment center
Name of recruitment center
Tabriz Emamreza Educational and Medical Center
Full name of responsible person
Bina Efterkhahsadat
Street address
Emamreza hospitl, ST golgasht
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
Iran Rasool Akram Hospital
Full name of responsible person
Bina Eftekharsadat
Street address
Iran university of medical sciences
City
Tehran
Province
Tehran
Postal code
5166614756
Phone
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir

4

Recruitment center
Name of recruitment center
Iran Neuromuscular Center
Full name of responsible person
Bina Eftekharsadat
Street address
Iran,Tehran
City
Tehran
Province
Tehran
Postal code
5166614756
Phone
+98 41 3335 2073
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
Tabriz university of medical scienced
City
Tabriz
Province
East Azarbaijan
Postal code
3322359680
Phone
+98 41 3335 5921
Email
herasat@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
Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
41 33371134
Phone
+98 41 3337 1134
Email
pmrrc@tbzmed.ac.ir

Person responsible for scientific 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
Rehabilitation ward, Imam Reza hospital, Golgasht ave.
City
Tabriz
Province
East Azarbaijan
Postal code
1330 31933
Phone
+98 41 1330 3193
Fax
+98 41 1337 3967
Email
binasadat@tbzmed.ac.ir

Person responsible for updating data

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
Rehabilitation ward, Imam Reza hospital, Golgasht ave.
City
Tabriz
Province
East Azarbaijan
Postal code
41 1330 3193
Phone
+98 41 1330 3193
Fax
+98 41 1337 3967
Email
binasadat@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
paper
When the data will become available and for how long
2020
To whom data/document is available
students
Under which criteria data/document could be used
sharing for using
From where data/document is obtainable
Tabriz university of medical sciences
What processes are involved for a request to access data/document
email send
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