Comparison of the Effect of Collagen and Corticosteroid Intra-articular Injection on Function and Pain in Patients with First Carpometacarpal Joint Osteoarthritis
The purpose of this study is to investigate the effect of intra-articular injection of collagen and corticosteroids on the function and pain of patients with carpometacarpal joint osteoarthritis.
Design
This clinical trial study has a control group, with parallel groups, three blinded, randomized, phase 3 of clinical trial on 50 patients.
Settings and conduct
Subjects, interventionist, outcome assessor, statistician and the researcher are all blind to treatment groups allocation; us2 groups of 25 (injection of Steroid, collagen).The study will take place in Modares hospital.
Participants/Inclusion and exclusion criteria
Patients aged 40 to 70 years with first carpometacarpal osteoarthritis who are grade 2 and 3 based on radiographic criteria and have had moderate to severe pain in the first carpometacarpal joint for at least 3 months, which is resistant to drug treatment.
Intervention groups
Group one: patients who are treated with intra-articular injection of corticosteroids.
Group two: patients who are treated with intra-articular injection of collagen.
Main outcome variables
Pain at the base of the thumb; the patient's performance in daily activities; The strength of the thumb; The need for painkillers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240126060813N1
Registration date:2024-03-04, 1402/12/14
Registration timing:prospective
Last update:2024-03-04, 1402/12/14
Update count:0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Seyed Mansoor Rayegani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
rayegani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Collagen and Corticosteroid Intra-articular Injection on Function and Pain in Patients with First Carpometacarpal Joint Osteoarthritis
Public title
Comparison of the Effect of Collagen and Corticosteroid Intra-articular Injection on Function and Pain in Patients with First Carpometacarpal Joint Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with first carpometacarpal osteoarthritis based on radiographic criteria grade 2 and 3 and have moderate to severe pain (VAS>=5) in the first carpometacarpal joint for at least 3 months, which is resistant to drug treatment.
Exclusion criteria:
The patient's willingness to withdraw from the study at any stage of the design
The presence of any acute or chronic infection of the joint or around the joint
Pregnancy
Any intra-articular injection of the first carpometacarpal joint was performed during the last three months.
History of oral and systemic corticosteroid use in the last two weeks
Use of NSAIDs within 2 weeks prior to injection
Existence of inflammatory joint diseases such as rheumatoid arthritis, spondyloarthropathies, connective tissue diseases, gout, Paget's, septic arthritis
History of neurological syndromes caused by entrapment of the peripheral nerves of the hands, such as carpal tunnel syndrome
History of surgery in the hand
Recent history of severe trauma to the hand
Having a severe underlying disease such as uncontrolled diabetes
Autoimmune and platelet disorders, treatment with anticoagulant and antiplatelet drugs within 10 days before injection
Daily use of opioid and non-opioid analgesics
Taking topical painkillers
Hemarthrosis
Erythema or psoriatic lesions at the injection site
Age
From 40 years old to 70 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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial study, 50 patients with a diagnosis of first Carpometacarpal Joint Osteoarthritis will be included in the study randomly For random allocation of individuals in the study groups (intervention or intervention group and comparison or comparison group), the method of random allocation with block method (Block Randomization) will be used In this method, blocks with size of six (including three people in the intervention group and three people in the comparison group) with a ratio of 1: 1 will be used. Random Allocation software will be used to generate random sequences. For concealment, the random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified with two type of cards which are including group a (intervention group) and b (comparison group) and these cards are placed inside the sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The researcher, patients and the collaborator of the project who will perform the statistical analysis will not be aware of the study. grouping of patients will be noted and will be shared to one of the partners.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
1402.166.IR.SBMU.MSP.REC
Health conditions studied
1
Description of health condition studied
First Carpometacarpal Joint Osteoarthritis
ICD-10 code
M18.1
ICD-10 code description
Unilateral primary osteoarthritis of first carpometacarpal joint
2
Description of health condition studied
First Carpometacarpal Joint Osteoarthritis
ICD-10 code
M18.0
ICD-10 code description
Bilateral primary osteoarthritis of first carpometacarpal joints
Primary outcomes
1
Description
Pain in base of thumb
Timepoint
At the beginning of the study (before the start of the intervention) and one month and three months after the intervention
Method of measurement
Visual analogue scale (VAS)
2
Description
patient 's function
Timepoint
At the beginning of the study (before the start of the intervention) and one month and three months after the intervention
Method of measurement
FIHOA questionnaire scores
3
Description
The strength of the thumb
Timepoint
At the beginning of the study (before the start of the intervention) and one month and three months after the intervention
Method of measurement
Dynamometer
4
Description
The need for painkillers
Timepoint
At the beginning of the study (before the start of the intervention) and one month and three months after the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25 patients with osteoarthritis of the first carpometacarpal joint who will be treated with intra-articular injection of collagen.
Category
Treatment - Drugs
2
Description
Control group: 25 patients with osteoarthritis of the first carpometacarpal joint who will be treated with intra-articular injection of Corticosteroids.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Seyed Mansoor Rayegani
Street address
Shahid Modarres hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
rayegani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mansoor Rayegani
Street address
Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
rayegani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Faghihi Kashani
Position
Resident of Physical medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine and Rehabilitation Research Center, Shohada Tajrish hospital, Qods square, Tajrish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 4210
Email
dmfk.pmr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mansoor Rayegani
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine and Rehabilitation Research Center, Shohada Tajrish hospital, Qods square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 4210
Email
Rayegani@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Faghihi Kashani
Position
Resident of Physical medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine and Rehabilitation Research Center, Shohada Tajrish hospital, Qods square, Tajrish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 4210
Email
dmfk.pmr@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the data of people participating in this study can be shared after deidentifying people.
When the data will become available and for how long
The access period starts one year after the results are published
To whom data/document is available
Data of this study will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers
From where data/document is obtainable
By sending an email to dmfk.pmr@gmail.com
What processes are involved for a request to access data/document
Sending an email of requesting information and explaining the purpose and how to use the data