Evaluation of Efficacy of electroacupuncture on pain, shoulder functional disability, healing of supraspinatus tendon in patients with partial supraspinatus tendon rupture.
Determining the effectiveness of electroacupuncture on pain, range of motion, shoulder functional disability and supraspinatus tendon repair in people with partial supraspinatus tendon rupture.
Design
This study is a single-blind randomized controlled clinical trial with 38 participants
Settings and conduct
application of electroacupuncture on patients with partial tear of the supraspinatus tendon referred to the Faculty of Rehabilitation of Hamadan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
1- Diagnosis of partial tear of the supraspinatus tendon (tear size less than 3 mm) by a shoulder specialist orthopedic doctor and based on MRI of the patient's shoulder
2- Patient age between 20 and 40 years
3- Patients should have pain intensity between 3 and 7 on a ten-point scale and during the last two weeks during activity.
4- Having a painful arch in the movement of the shoulder
5- Positive results of clinical diagnostic tests including Drop arm test
Intervention groups
Intervention group: receiving basic treatment with electroacupuncture. Control group: Receiving basic treatment.
Main outcome variables
Pain, functional disability, and size of tendon tear
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190315043058N5
Registration date:2024-07-25, 1403/05/04
Registration timing:prospective
Last update:2024-07-25, 1403/05/04
Update count:0
Registration date
2024-07-25, 1403/05/04
Registrant information
Name
Ismail Ebrahimi Takamjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2239 2426
Email address
ebrahimitakamjani.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Efficacy of electroacupuncture on pain, shoulder functional disability, healing of supraspinatus tendon in patients with partial supraspinatus tendon rupture.
Public title
Evaluation of Efficacy of electroacupuncture on partial supraspinatus tendon rupture.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of partial tear of the supraspinatus tendon
Exclusion criteria:
Referral pain from the neck
Previous shoulder surgery
injection in the last 3 months
Complete tear or more than 3 mm of the tendon of the supraspinatus muscle
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
andom allocation will be done in the variable block method, which consists of four-letter blocks made up of letters A and B. Then, the random list of treatments that will be obtained at the end of the assignment will be placed in the letters A and B in sealed and numbered envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be given envelopes in a closed envelope before the start of the first treatment session, and one of the letters A or B will be written. Attendees deliver envelopes to their therapist, only the therapist is allowed to open the envelopes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1341853347
Approval date
2024-07-22, 1403/05/01
Ethics committee reference number
IR.IUMS.REC.1403.353
Health conditions studied
1
Description of health condition studied
Partial tear of the supraspinatus tendon
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff or supraspinatus tear or rupture (complete)(incomplete), not specified as traumaticSupraspinatus syndrome
Primary outcomes
1
Description
Pain
Timepoint
Pain measurement in the first session, 12 and 6 months after the end of the treatment.
Method of measurement
Numeric pain rating scale
2
Description
Functional disability
Timepoint
Functional disability measurement in the first session, 12 and 6 months after the end of the treatment.
Method of measurement
Persian version of DASH questioner
3
Description
shoulder range of motion
Timepoint
shoulder range of motion measurement in the first session, 12 and 6 months after the end of the treatment.
Method of measurement
Universal goniometer
Secondary outcomes
1
Description
Supraspinatus tendon tear size
Timepoint
The size of the supraspinatus tendon tear will be measured in the first session and 6 months after the treatment
Method of measurement
MRI devices
Intervention groups
1
Description
Intervention group: electroacupuncture will be performed using Z model electroacupuncture device (made in China), two sessions a week, each session will be 15 minutes and for 12 weeks.
Category
Rehabilitation
2
Description
Control group: Physiotherapy routine treatment will include 20 minutes of normal tennis (200 Hz frequency, 50 microsecond pulse duration) along with infrared, isometric and eccentric exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic of Faculty of Rehabilitation Sciences, Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asadi
Street address
Mahdieh St. - Mubasher Kashani Physiotherapy Clinic
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۸۷
Phone
+98 81 3838 1571
Email
reza.asadi21@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak
Street address
Hemmat Highway., Next to Milad Tower., Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86710
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Ismail Ebrahimi Takamjani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 195, Khalili Alley, Saba Blvd., Rumi Bridge, Shariati Street, Tehran
City
Tehran
Province
Tehran
Postal code
1998135353
Phone
+98 21 2239 2426
Email
Ebrahimitakamjani.e@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gholamreza Hajvaliei
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Shahnazari Ave., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1998135353
Phone
+98 81 3838 1571
Email
gh.hajvaliei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ismail Ebrahimi Takamjani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 195, Khalili Alley, Saba Blvd., Rumi Bridge, Shariati Street, Tehran
City
Tehran
Province
Tehran
Postal code
1998135353
Phone
+98 21 2239 2426
Email
Ebrahimitakamjani.e@iums.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