Protocol summary
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Study aim
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Determine the effectiveness of metacarpophalengeal static splint on pain reduction and function improvement of the adult patients with trigger finger
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Design
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Randomized clinical trial with two parallel group, with control group
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Settings and conduct
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The patients with trigger finger referred to the rehabilitation center at Shariati hospital
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Group A: Methylprednisolone injection in pulley A1
Group B: Injection and splinting of MCP joint
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Main outcome variables
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Pain, functional status, hand's strength, stage of disease
General information
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Reason for update
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Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
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Acronym
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IRCT registration information
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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
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Registration date
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2020-09-09, 1399/06/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-20, 1399/02/01
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Expected recruitment end date
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2021-04-09, 1400/01/20
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Actual recruitment start date
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2020-09-20, 1399/06/30
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Actual recruitment end date
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2021-04-21, 1400/02/01
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Trial completion date
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2021-07-21, 1400/04/30
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Scientific title
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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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Public title
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Evaluation of the effectiveness of metacarpophalengeal static splint on the adult patients with trigger finger
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-12-12, 1398/09/21
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.691
Health conditions studied
1
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Description of health condition studied
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The adult patients with trigger finger
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ICD-10 code
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M65.3
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ICD-10 code description
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Trigger finger
Primary outcomes
1
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Description
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Functional status
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Timepoint
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Beginning of the study (before intervention), one month and three months after intervention
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Method of measurement
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Boston assessment questionnaire
2
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Description
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Pain
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Timepoint
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Beginning of the study (before intervention), one month and three months after intervention
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Method of measurement
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Numeric pain rating
3
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Description
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The strength of the fingers
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Timepoint
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Beginning of the study (before intervention), one month and three months after intervention
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Method of measurement
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Dynamometer
4
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Description
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Stage of disease
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Timepoint
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Beginning of the study (before intervention), one month and three months after intervention
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Method of measurement
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Stages of stenosing tenosynovtits
Intervention groups
1
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Description
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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)
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Category
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Treatment - Devices
2
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Description
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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).
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Patient privacy
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data can be shared after patient are not going to be identified
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When the data will become available and for how long
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6 months after the end of the study
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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For use in related studies
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From where data/document is obtainable
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Corresponding Author
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What processes are involved for a request to access data/document
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By email
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Comments
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