Investigating the effect of magnet therapy in improving shoulder joint pain and function in patients with shoulder impingement syndrome who referred to the physical medicine and rehabilitation clinic of Isfahan University of Medical Sciences.
Design
The sample size required for the study was estimated to be 33 patients in each group, and for more certainty, 35 patients in each group will be studied. Sampling is done in an easy way and randomization of patients is done using random allocation software. In this software, the total sample size and the number of groups are entered into the software.
Settings and conduct
This is a single-blind clinical trial study that was conducted in 1402 at Amin Hospital in Isfahan. The target population of the study will be patients with shoulder impingement syndrome referring to the mentioned hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria
A patient with shoulder joint impingement syndrome
- At least one month has passed since the patient's symptoms.
- Age range from 18 to 65 years
Informed consent of the patient to enter the study
Exit criteria
- Changing the treatment technique for various reasons during the study
- Non-cooperation of the patient during the treatment period
- Performing parallel treatments by the patient
- Lack of follow-up visits of the patient to perform intervention or to evaluate the outcome of the treatment
Intervention groups
In this plan, 70 patients with shoulder joint impingement syndrome are divided into two groups.
In the first group, drug treatment and exercise and magnet therapy are used, and in the second group, drug treatment and exercise are used for treatment.
Main outcome variables
Reduce shoulder pain; Increase shoulder range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231024059830N1
Registration date:2023-10-29, 1402/08/07
Registration timing:prospective
Last update:2023-10-29, 1402/08/07
Update count:0
Registration date
2023-10-29, 1402/08/07
Registrant information
Name
najmeh askarianfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3265 6319
Email address
najmeaskarianfard93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of magnet therapy in improving pain and shoulder joint function in patient with impingement syndrome
Public title
shoulder in patient with impingement syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient with shoulder joint impingement syndrome who has pain in the shoulder area and has limitations in active shoulder abduction between 60 and 120 degrees and has referred to physical medicine and rehabilitation clinics affiliated to Isfahan University of Medical Sciences. Based on the criteria of the reference book Frontera and by physical medicine specialist
At least one month has passed since the patient's symptoms. Based on similar studies, this criterion has been set and the intention is that chronic cases will not be included in this study.
Age range from 18 to 65 years
Informed consent of the patient to enter the study
Exclusion criteria:
Changing the treatment technique for various reasons during the study. We mean changing the technique by the patient himself (for example, going to another doctor and receiving another modality)
Non-cooperation of the patient during the treatment period
Performing parallel treatments by the patient
Lack of follow-up visits of the patient to perform intervention or to evaluate the outcome of treatment
Injection of corticosteroid into the shoulder joint in the last month
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done in an easy way and according to it, patients were examined according to the time of visit and entered the study if they met the entry conditions.
Randomization of patients is done using random allocation software. In this software, the total sample size and the number of groups are entered into the software. The output of the software includes a list that randomly distributes patients according to number between two groups. The patients are distributed in two groups according to the order of the visit time, according to the mentioned list, so that the sample volume reaches the number of slides in each group
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients with shoulder joint impingement syndrome referred to Amin Hospital after being placed in the magnet device do not know whether the device is on or off.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor, Ethics Committee Secretariat
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-10-20, 1402/07/28
Ethics committee reference number
IR.MUI.MED.REC.1402.267
Health conditions studied
1
Description of health condition studied
shoulder impingement syndrome
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
Shoulder impingement syndrome
Timepoint
Before, immediately and 4 weeks
Method of measurement
Visual Analogue Scale (VAS) , Goniometer, Disabilities of the Arm Shoulder and Hand (DASH)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Devices
2
Description
Control group:
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
najme askarianfard
Street address
Amin Medical Education Center,Sanbulistan Street, Sina Steet, Shahada Square
City
Esfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3112 2020
Email
najmeaskarianfard93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholam Reza Askari
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Najmeh Askarianfard
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Bozormehr Square, Mushtaq First St., Abolhassan Esfahani St.Shahid Tajuddin Alley,Ban Best Omid,No. 10
City
Isfahan
Province
Isfehan
Postal code
8153796911
Phone
+98 31 3265 6319
Fax
Email
najmeaskarianfard93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Taheri
Position
Associate Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Isfahan, Al-Zahra Hospital, Department of Physical Medicine
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 2174
Email
Prs_taheri@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Najmeh Askarianfard
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Bozormehr Square, Mushtaq First St., Abolhassan Esfahani St.Shahid Tajuddin Alley,Ban Best Omid,No. 10
City
Isfahan
Province
Isfehan
Postal code
8153796911
Phone
+98 31 3265 6319
Fax
Email
najmeaskarianfard93@gmail.com
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
No - There is not 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
No - There is not 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