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Evaluation of the effectiveness of metacarpophalengeal static splint on pain reduction and function improvement of the adult patients with trigger finger

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History
# Registration date Revision Id
2 2021-07-21, 1400/04/30 192283
1 2020-09-09, 1399/06/19 150207
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  • General information

    60
    80
    empty
    60
    2021-04-21, 1400/02/01
    2021-04-09, 1400/01/20
    empty
    2020-09-20, 1399/06/30
    empty
    2021-04-21, 1400/02/01
    empty
    2021-07-21, 1400/04/30
    empty
    Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
    empty
    ثبت حجم نمونه تحقق یافته ، تاریخ شروع و پایان نمونه گیری تحقق یافته و تاریخ خاتمه کارآزمایی
    20-60 y/o
    The individuals should not have received similar treatments before and during this study
    One affected finger
    No contraindication for injection
    All participants should receive and fill the consent form
    No contraindication for splinting
    SST>2
    20-80 y/o
    The individuals should not have received similar treatments before and during this study
    One affected finger
    No contraindication for injection
    All participants should receive and fill the consent form
    No contraindication for splinting
    SST>2
    سن افراد 20 تا 60 سال باشد
    افراد در طول درمان و تا قبل از این مطالعه درمان های مشابه دریافت نکرده باشد
    تعداد انگشت درگیر فقط یک مورد باشد
    هیچ کانتراندیکاسیونی برای تزریق نداشته باشد
    همه شرکت کنندگان باید فرم رضایت آگاهانه ورود به مطالعه را تکمیل کرده باشند.
    هیچ کانتراندیکاسیونی برای اسپیلنت نداشته باشند
    بیماران با Stages of stenosing tenosynovitis بالاتر از 2
    سن افراد 20 تا 80 سال باشد
    افراد در طول درمان و تا قبل از این مطالعه درمان های مشابه دریافت نکرده باشد
    تعداد انگشت درگیر فقط یک مورد باشد
    هیچ کانتراندیکاسیونی برای تزریق نداشته باشد
    همه شرکت کنندگان باید فرم رضایت آگاهانه ورود به مطالعه را تکمیل کرده باشند.
    هیچ کانتراندیکاسیونی برای اسپیلنت نداشته باشند
    بیماران با Stages of stenosing tenosynovitis بالاتر از 2

  • Recruitment centers

    #1
    Name of recruitment center - English: Shariati hospital
    Name of recruitment center - Persian: بیمارستان شریعتی
    Full name of responsible person - English: Saeed Reza Mehrpoor
    Full name of responsible person - Persian: سعیدرضا مهرپور
    Street address - English: Jalal Ale-ahmad highway
    Street address - Persian: بزرگراه جلال آل احمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1111111111
    Phone: +98 21 8822 5880
    Fax:
    Email: hr-fateh@tums.ac.ir
    Web page address:
    Name of recruitment center - English: Shariati hospital
    Name of recruitment center - Persian: بیمارستان شریعتی
    Full name of responsible person - English: Saeed Reza Mehrpoor
    Full name of responsible person - Persian: سعیدرضا مهرپور
    Street address - English: Jalal Ale-Ahmad Highway
    Street address - Persian: بزرگراه جلال آل احمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1111111111
    Phone: +98 21 8822 5880
    Fax:
    Email: hr-fateh@tums.ac.ir
    Web page address:

Protocol summary

Study aim
Determine the effectiveness of metacarpophalengeal static splint on pain reduction and function improvement of the adult patients with trigger finger
Design
Randomized clinical trial with two parallel group, with control group
Settings and conduct
The patients with trigger finger referred to the rehabilitation center at Shariati hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: 20-60 y/o Participate in other studies and interventions One affected finger No contraindication for injection All participants should receive and fill the consent forms No contraindication for splinting SST>2 Exclusion criteria: Patients with CNS disorder, peripheral neuropathy and osteoarthritis Who has proper cooperation in the course of study
Intervention groups
Group A: Methylprednisolone injection in pulley A1 Group B: Injection and splinting of MCP joint
Main outcome variables
Pain, functional status, hand's strength, stage of disease

General information

Reason for update
Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
Acronym
IRCT registration information
IRCT registration number: IRCT20180804040685N3
Registration date: 2020-09-09, 1399/06/19
Registration timing: prospective

Last update: 2021-08-01, 1400/05/10
Update count: 1
Registration date
2020-09-09, 1399/06/19
Registrant information
Name
Hamid Reza Fateh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2110
Email address
hr-fateh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-04-09, 1400/01/20
Actual recruitment start date
2020-09-20, 1399/06/30
Actual recruitment end date
2021-04-21, 1400/02/01
Trial completion date
2021-07-21, 1400/04/30
Scientific title
Evaluation of the effectiveness of metacarpophalengeal static splint on pain reduction and function improvement of the adult patients with trigger finger
Public title
Evaluation of the effectiveness of metacarpophalengeal static splint on the adult patients with trigger finger
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-80 y/o The individuals should not have received similar treatments before and during this study One affected finger No contraindication for injection All participants should receive and fill the consent form No contraindication for splinting SST>2
Exclusion criteria:
The patients with CNS disorder, peripheral neuropathy and osteoarthritis Who has proper cooperation in the course of study
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
After initial evaluation, samples will be assigned into one of the 2 groups A or B group using sealed envelops, the patients have to pick up one the sealed envelops, so their group will be defined randomly
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee, Tehran University of Medical Sciences
Street address
Jalal Ale-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2019-12-12, 1398/09/21
Ethics committee reference number
IR.TUMS.VCR.REC.1398.691

Health conditions studied

1

Description of health condition studied
The adult patients with trigger finger
ICD-10 code
M65.3
ICD-10 code description
Trigger finger

Primary outcomes

1

Description
Functional status
Timepoint
Beginning of the study (before intervention), one month and three months after intervention
Method of measurement
Boston assessment questionnaire

2

Description
Pain
Timepoint
Beginning of the study (before intervention), one month and three months after intervention
Method of measurement
Numeric pain rating

3

Description
The strength of the fingers
Timepoint
Beginning of the study (before intervention), one month and three months after intervention
Method of measurement
Dynamometer

4

Description
Stage of disease
Timepoint
Beginning of the study (before intervention), one month and three months after intervention
Method of measurement
Stages of stenosing tenosynovtits

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Injection (40 mg Methyl prednisolone) in pulley A1 and splinting of MCP joint; All injections would be made via insulin needle (gauge 29, and length 2.1 inch)
Category
Treatment - Devices

2

Description
Control group: Injection (40 mg Methyl prednisolone) in pulley A1; All injections would be made via insulin needle (gauge 29, and length 2.1 inch).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Saeed Reza Mehrpoor
Street address
Jalal Ale-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8822 5880
Email
hr-fateh@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Imam Khomeini Ave., Hasan Abad Sq., Sina Hospital Tehran – Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6405 3491
Email
deanmed@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza Fateh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Jalal Ale-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
111111111
Phone
+98 21 8822 5880
Email
hr-fateh@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza Fateh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Jalal Ale-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8822 5880
Email
hr-fateh@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza Fateh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Jalal Ale-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8822 5880
Email
hr-fateh@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patient privacy
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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 can be shared after patient are not going to be identified
When the data will become available and for how long
6 months after the end of the study
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in related studies
From where data/document is obtainable
Corresponding Author
What processes are involved for a request to access data/document
By email
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