The effects of Active Release Technique and exercise therapy on pain and function in nonprofessional adult athletes with chronic supraspinatus tendinopathy
The effects of Active Release Technique and exercise therapy on pain and function in nonprofessional adult athletes with chronic supraspinatus tendinopathy
Design
A randomize trial with a control group, a single blind strain on 30 patients was used for randomization using the block method
Settings and conduct
invatation-Match the bags with the study criteria-Providing explanations and receiving consent from the cases-Referring the cases to an orthopedic specialist and receiving a written confirmation of the case's damage Our study in cases-Randomization of cases into two intervention and control groups-Evaluation of range of motion of flexion, abduction, external rotation of the shoulder with an inclinometer, evaluation of the strength of the supraspinatus muscle with a dynamometer, evaluation of the pressure pain threshold of the muscles of the supraspinatus, middle deltoid, and upper trapezius with an algometer, and determining the level of visual pain with the VAS questionnaire by therapist different from the researcher-Starting the treatment with the protocol of the intervention group: performing 12 ART sessions three times a week and simultaneously 12 exercise sessions three times a week.Control group protocol: 12 training sessions three times a week-Re-evaluation
Participants/Inclusion and exclusion criteria
Non-professional athletes 2) Pain in sport activities in last 3 month 3) Age limitation 20-45 4) Body mass index below 30 5) being positive at least 2 of these test: empty can, painful arc, Hawkins exclusion 1)all contraindication of shock wave 2) history of surgery, fracture or osteoarthritis in the treatment areas
Intervention groups
1) 12 ART sessions three times a week, 12 trainning sessions three times a week
Main outcome variables
pain reduction,Improve range of motion and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221007056107N1
Registration date:2023-01-07, 1401/10/17
Registration timing:prospective
Last update:2023-01-07, 1401/10/17
Update count:0
Registration date
2023-01-07, 1401/10/17
Registrant information
Name
Ghazal Limoie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8809 6337
Email address
limooie.gh.72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Active Release Technique and exercise therapy on pain and function in nonprofessional adult athletes with chronic supraspinatus tendinopathy
Public title
Effect of ART on chronic supraspinatus tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
non-professional athletes(2 to 3 hours per week)
pain in sport activities in last 3 month
Age limitation 20-45
Body mass index below 30
being positive at least 2 of these test : empty can, painful arc,Hawkins
Exclusion criteria:
history of surgery, fracture or osteoarthritis in the treatment areas
frozen shoulder
all contraindication of manual tecniqe
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
aabb
Bbaa
Abab
Baba
Abba
Baab
1)Write these items on six paper and put in the six packets
2) Draw eight times until eight envelopes are selected , provided that the envelopes are repeated
3) Each characteristics of the specification of the four allocations of the individual
Blinding (investigator's opinion)
Single blinded
Blinding description
After the examination (by another physiotherapist) and making sure that they have the conditions to enter the study, people will be admitted to one of the ART groups or exercise therapy through a sealed envelope.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethic committee of Iran University of medical science
Street address
Iran University of Medical Sciences ,Next to Borj Milad, Hammet Highway
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-10-04, 1401/07/12
Ethics committee reference number
IR.IUMS.REC.1401.562
Health conditions studied
1
Description of health condition studied
Shoulder impingment syndrome
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
Primary outcomes
1
Description
1-Range of motion of flextion, abduction, external rotation of the shoulder
Timepoint
At the first and end of treatment program
Method of measurement
Range of motion with inclinumeter.
2
Description
Strength of the supraspinatus muscle.
Timepoint
At the first and end of treatment program
Method of measurement
Strength muscle with dynamometer
3
Description
Pain pressure threshold of the muscle of supraspinatus , middle deltoid , and upper trapezius .
Timepoint
At the first and end of treatment program
Method of measurement
Pain pressure thresholde with algometer
4
Description
Amount of Visual Analog Scale before and after each session.
Timepoint
Before and after of each session
Method of measurement
Visual Analog Scale (VAS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: 12 sessions (3 sessions per week) of the ART technique are performed on the supraspinatus, middle deltoid, and upper trapezius muscles.and moved shorting muscle length to long muscle length . this contact is held for 5-10 s . this was performed 3-5 time.
Category
Rehabilitation
2
Description
Control group: Control group: 12 sessions (3 sessions per week) exercises include: scapula stabilizer (external rotation-scaption lawnmower) and rotator cuff strengthening (side lying external rotation). The intensity of these exercises in the first two weeks is 30-40 1RM and in the second two weeks 50-70 1RM. 3 sets of 12 and stretching exercises (cross body and corner strech) 3 sets of 30 seconds
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
oxin physiotherapy
Full name of responsible person
Ghazal Limooie
Street address
No.11/9,Fakharmoghadam Ave.,Dadman Ave.,Sanat Sq.,Qods Town
City
Tehran
Province
Tehran
Postal code
1981619420
Phone
+98 21 2676 7708
Email
limooie.gh.72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Street address
Physical Therapy Dept., 3rd floor, school of rehabilitation sciences, Madadkaran Ave., Shah nazari St., Maadar Sq.,Mirdamaad Blv., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
taghizadeh.gh@yahoo.com
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
Ghazal Limooie
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.11/9,Fakharmoghadam Ave.,Dadman Ave.,Sanat Sq.,Qods Town
City
Tehran
Province
Tehran
Postal code
1981619420
Phone
+98 21 2676 7708
Email
limooie.gh.72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soheil-Mansour Sohani
Position
Associate professor of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
floor, school of rehabilitation sciences, Madadkaran Ave., Shah nazari St., Maadar Sq.,Mirdamaad Blv., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
mansorsohani.s@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghazal Limooie
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.11/9,Fakharmoghadam Ave.,Dadman Ave.,Sanat Sq.,Qods Town
City
Tehran
Province
Tehran
Postal code
1981619420
Phone
+98 21 2676 7708
Email
limooie.gh.72@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
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