To assess the effect of acupuncture versus control group on Trigger finger disease
Design
This is a Phase III randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using drawing lots.
Settings and conduct
This study will be conducted at the Besat Hospital in Hamadan, involving 68 eligible patients with Trigger finger disease. The patients will be randomly assigned to the intervention and control groups through the drawing lots. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Being at the age of 18 to 70 years;
Trigger finger disease
Exclusion criteria:
Rheumatoid arthritis disease;
Carpal tunnel syndrome;
Coagulation disorders or use of anticoagulants;
The presence of scars at the place of acupuncture
Intervention groups
Intervention group: Injection of methylprednisolone 40 mg into the joint capsule three times a week for one month, plus acupuncture with a 0.16 x 7 mm needle using the Ah-shi point method for 30 minutes three times a week for 10 sessions.
Control group: Injection of methylprednisolone 40 mg into the joint capsule three times a week for one month
Main outcome variables
Average pain intensity, average active range of motion of the affected finger joint, average disease score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N513
Registration date:2024-05-29, 1403/03/09
Registration timing:prospective
Last update:2024-05-29, 1403/03/09
Update count:0
Registration date
2024-05-29, 1403/03/09
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-09, 1403/03/20
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupuncture versus control group on Trigger finger disease: a randomized clinical trial
Public title
Effect of acupuncture on Trigger finger disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Trigger finger disease
Exclusion criteria:
Rheumatoid arthritis disease
Carpal tunnel syndrome
Coagulation disorders or use of anticoagulants
The presence of scars at the place of acupuncture
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by drawing lots. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or control group.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2024-05-18, 1403/02/29
Ethics committee reference number
IR.UMSHA.REC.1403.124
Health conditions studied
1
Description of health condition studied
Trigger finger disease
ICD-10 code
M65.3
ICD-10 code description
Trigger finger
Primary outcomes
1
Description
Average pain intensity
Timepoint
Before the intervention and one month later
Method of measurement
Using Visual Analog Scale (VAS)
2
Description
Average active range of motion of the affected finger joint
Timepoint
Before the intervention and one month later
Method of measurement
Using a goniometer
3
Description
Average disease score
Timepoint
Before the intervention and one month later
Method of measurement
Based on the trigger finger scoring table
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of methylprednisolone 40 mg into the joint capsule three times a week for one month, plus acupuncture with a 0.16 x 7 mm needle using the Ah-shi point method for 30 minutes three times a week for 10 sessions.
Category
Other
2
Description
Control group: Injection of methylprednisolone 40 mg into the joint capsule three times a week for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Milad Spehri
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
milad.spr78@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Milad Spehri
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
milad.spr78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Nikta Nikbakht
Position
Physical Medicine Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
drniktanikbakht@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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