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Comparison of the effectiveness of injection and high power laser therapy in trigger finger patients

Protocol summary

Study aim
Comparison of the therapeutic effect of injection and high-power laser on pain and function of patients with trigger finger
Design
Randomization is block randomization in which 6 blocks of 4 will be used (AABB, ABAB, ABBA, BBAA, BABA, BAAB). Then, using the table of random numbers, each of the blocks will be selected and the patients will be referred to the relevant intervention. After the completion of all four patients, this process will be repeated for the next four patients until the completion of the entire statistical population and the completion of the process.
Settings and conduct
This is an interventional study in the form of a randomized clinical trial that is conducted in Imam Reza Army Hospital in Tehran in 1403. Patients in one of two groups are treated with high power laser or injection. Before the intervention, one month later and once three months after the intervention, the patients are examined in terms of Quinnell's classification, pain NRS and quick DASH.
Participants/Inclusion and exclusion criteria
Inclusion Criteria : patients aged 20-65 years Patient's informed consent and willingness to participate in the study Trigger finger Quinell classification 2-3 Exclusion Criteria : Trigger finger in children Trigger finger caused by trauma Secondary causes of trigger finger Presence of active infection in the site History of tumor and malignancy at the site Pregnancy and breastfeeding coagulation disorders Taking anticoagulant drugs
Intervention groups
injection treatment group, the intervention is 1 session. high-power laser treatment group, patients undergo 5 regular sessions (one day in between) of high-power laser with an intensity of 10 W/cm2. For both treatment groups, anti-inflammatory drug (Celecoxib 200) and splint are prescribed.
Main outcome variables
Pain NRS; Quinnell grading system; QuickDASH score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240618062163N1
Registration date: 2024-08-10, 1403/05/20
Registration timing: registered_while_recruiting

Last update: 2024-08-10, 1403/05/20
Update count: 0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Mahdi Kianimehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3317 0354
Email address
m.kianimehr@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-03-18, 1403/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of injection and high power laser therapy in trigger finger patients
Public title
Comparison of injection and high power laser in the treatment of trigger finger
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
trigger finger patients with Quinnell grading system 2 & 3
Exclusion criteria:
trigger finger in children trauma associated trigger finger secondary causes such as tuberculous synovitis, tendon sheath tumor, ... active infection at the site history of tumor and neoplasm at the site pregnancy and breastfeeding Coagulation disorders Taking anticoagulant drugs
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is block randomization in which 6 blocks of 4 will be used (AABB, ABAB, ABBA, BBAA, BABA, BAAB). Then, using the table of random numbers, each of the blocks will be selected and the patients will be referred to the relevant intervention. After the completion of all four patients, this process will be repeated for the next four patients until the completion of the entire statistical population and the completion of the process.
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
Ethics committee of AJA University of Medical Sciences
Street address
Imam Reza Hospital, Fatemi Street, Etemadzadeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2024-06-15, 1403/03/26
Ethics committee reference number
IR.AJAUMS.REC.1403.063

Health conditions studied

1

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

Primary outcomes

1

Description
Numeric Pain Rating Scale
Timepoint
At the beginning of the study (before the start of the intervention) and 1 and 3 months after the start of the treatment
Method of measurement
questionnaire

2

Description
clinical severity of trigger finger.
Timepoint
At the beginning of the study (before the start of the intervention) and 1 and 3 months after the start of the treatment
Method of measurement
Based on this Classification, trigger fingers are rated as follows: 0 normal finger movement. 1 movement Uneven and unfavorable finger; 2 finger lock that can be actively modified. 3 to lock A finger that can be passively corrected. and 4-finger fixed lock

Secondary outcomes

1

Description
Physical function and symptoms
Timepoint
At the beginning of the study (before the start of the intervention) and 1 and 3 months after the start of the treatment
Method of measurement
QuickDASH is a shortened version of DASH measure outcome that instead of 30 items, QuickDASH uses 11 items to measure physical performance and symptoms in people with one or more upper limb musculoskeletal disorders. This questionnaire asks about the person's symptoms and also the person's ability to perform some activities Each assigns a score

Intervention groups

1

Description
Intervention group: High-power laser treatment group, where patients undergo 5 regular sessions (one day in between) of high-power laser with an intensity of 3.5 joules.
Category
Treatment - Devices

2

Description
Control group: the injection treatment group, which is a 1-session intervention for each involved joint using a 30 gauge needle and a 1 ml syringe, with a combination of 0.7 ml of methylprednisolone 40 mg and 0.3 ml of 2% lidocaine on site. The flexor tendon sheath is injected (in the area of ​​the head of the metacarpal bone of the affected finger).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Mahdi Kianimehr
Street address
Imam Reza Hospital, Fatemi Street, Etemadzadeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
mail@ajaums.ac.ir
Web page address
https://www.ajaums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza Mosaed
Street address
Imam Reza Hospital, Fatemi Street, Etemadzadeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
mail@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Mahdi Kianimehr
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
M.kianimehr@ajaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mahdi Kianimehr
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Fatemi
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
mial@ajaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mahdi Kianimehr
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Fatemi
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
msil@ajaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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