Comparison of the effectiveness of 50% dextrose and corticosteroid injections in the treatment of osteoarthritis of the first metatarsophalangeal joint
Comparison of the effectiveness of Corticosteroid injection(methylprednisolone) with Dextrose 50% (prolotherapy) in osteoarthritis of the first metatarsophalangeal joint
This study will performed on patients who referred to physical medicine clinics in Shiraz in 2021, double blind ,and the patient and therapist are not aware of the selected drug
Participants/Inclusion and exclusion criteria
Patients aged 30 to 65 years with complaints of pain in the first metatarsophalangeal joint,
Exclusion criteria: Rheumatic diseases, diabetes, bone infection, surgery in the first metatarsophalangeal joint, coagulation problems, pregnancy, any injection in the first metatarsophalangeal joint of the foot in the last 6 months
Intervention groups
The first group of 16 people receive corticosteroid injection (methylprednisolone) and the second group of 16 people receive 50% dextrose injection (prolotherapy).
Main outcome variables
Based on criteria:
VAS questionnaire (Visual analog scale)
MOXFQ (Manchester -Oxford Foot Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210308050637N1
Registration date:2021-03-14, 1399/12/24
Registration timing:prospective
Last update:2021-03-14, 1399/12/24
Update count:0
Registration date
2021-03-14, 1399/12/24
Registrant information
Name
Batul safarri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5372 2583
Email address
betinaz8693@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of 50% dextrose and corticosteroid injections in the treatment of osteoarthritis of the first metatarsophalangeal joint
Public title
The effect of corticosteroid and dextrose injections in the treatment of osteoarthritis of the big toe joint
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain in first metatarsophalangeal joint of foot
No response to conventional treatments
Exclusion criteria:
Rhomatologic disease
Diabetes mellitus
Bone infection
Surgury in thr treated area
Coagulative disorder
Pregnancy
Any injection in first metatarsophalangeal joint of foot in the last 6 months
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Each of the 32 patients will be explained that they will be randomly placed in one of the intervention groups. If the patient is accepted to enter the study using a complete randomized block with Random allocation software, the patient will be placed in one of the two groups. Then, Opaque sealed envelopes are used to hide random sequences. The drugs are labeled A and B and are given to patients at random. In the end, 16 people will receive methylprednisolone and 16 people will receive 50% dextrose.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blinded. Patients are unaware of drugs for other groups. The results analyzer is also unaware of the interventions performed in each group and for each patient
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand ave, Shahid Faghihi hospital, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-12-01, 1398/09/10
Ethics committee reference number
IR.SUMS.MED.REC.1398.489
Health conditions studied
1
Description of health condition studied
Osteoarthritis of the firs metatarsophalangeal joint (Hallux rigidus)
ICD-10 code
M20.2
ICD-10 code description
Hallux rigidus
Primary outcomes
1
Description
Pain level
Timepoint
Measurement of pain at the beginning of the study, 1 week, 4 weeks and 8 weeks after injection
Method of measurement
Visual Analog Scale
2
Description
Function
Timepoint
Measurement of pain at the beginning of the study, 1 week, 4 weeks and 8 weeks after injection
Method of measurement
Manchester-Oxford Foot Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 16 patient, receive corticosteroid (methylprednisolone) injection. The injection will done at one time. Dose of methylprednisolone acetate (Exir) 1 cc + 1 cc Lidocaine 2%, the injection will be under sterile conditions with a 2 cc syringe (23 gauge), which is inserted from the medial side of the joint and the injection will be done at the top and bottom
Category
Rehabilitation
2
Description
Intervention group 2: 16 patients receive dextrose 50% (prolotherapy). The injection will done at one time. Prolotherapy with 1 cc dextrose 50% (Shahid Ghazi) + 1 cc Lidocaine 2%, the injection will be under sterile conditions with a 2 cc syringe (23 gauge), which is inserted from the medial side of the joint and the injection will be done at the top and bottom
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Mohammadjavad Hadianfard
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
hadianj@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaianzadeh
Street address
Zand Ave, Shahid Faghihi hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
hadianj@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammadjavad Hadianfard
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Zand Ave, Shahid Faghihi hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
hadianj@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammadjavad Hadianfard
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Zand Ave, Shahid Faghihi hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
hadianj@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Batul Safarri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Faghihi hospital, Zand Ave, Shiraz town
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 5372 2583
Fax
Email
betinaz8693@gmail.com
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
All data after unidentification can be shared
When the data will become available and for how long
Start access after publishing results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Will be answered depending on the case
From where data/document is obtainable
betinaz8693@gmail.com
What processes are involved for a request to access data/document
Send the email containing your request to the email address betinaz8693@gmail.com , it will be answered as soon as possible