Protocol summary

Study aim
Effects of focused shock wave on pain, rang of motion, muscle strength and quality of life in non professional athletes with chronic supraspinatus tendinopathy
Design
Randomized clinical trial, without control group, on 32 participant, using block randomization
Settings and conduct
This is two blinded block randomized clinical trial that compare the effects of shock wave and friction massage on supraspinatus tendinopathy. Evaluation and treatment of cases and is done by another physiotherapist in the Physiotherapy Clinic of Oxin The variables and measurement method and treatment protocol in the groups are as follows: Range of flexion, abduction, external rotation with an inclinometer, strength of the supraspinatus with a dynamometer, and pressure pain threshold of the supraspinatus, middle deltoid, and upper trapezius with an algometer، determination of visual pain using questionnaire before and after each treatment session and quality of life with questionnaire .Treatment protocol for group 1 performing 4 shock wave sessions and for group 2 performing 4 sessions friction massage once a week. both groups also receive 12 training sessions (3 times a week).
Participants/Inclusion and exclusion criteria
Inclusion criteria: non-professional athletes; pain in sport activities in last 3 months; age limitation 20-45 years old; body mass index below 30; being positive at least 2 of these test: empty can, painful arc, Hawkins. Exclusion criteria: all contraindication for shock wave; history of surgery, fracture or osteoarthritis in the treatment areas.
Intervention groups
Intervention group1: 4 shock wave sessions once a week Intervention group 2: 4 friction massage sessions once a week Both group recieve 12 sessions of exercise therapy ( 3 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: IRCT20220829055825N1
Registration date: 2023-01-01, 1401/10/11
Registration timing: prospective

Last update: 2023-01-01, 1401/10/11
Update count: 0
Registration date
2023-01-01, 1401/10/11
Registrant information
Name
Alireza Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2676 7708
Email address
karimi.ar@iums.ac.ir
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 focused shock wave on pain, range of motion, muscle strength and quality of life in non-professional athletes with chronic supraspinatus tendinopathy.
Public title
Effect of focused shock wave 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 years old Body mass index below 30 Being positive at least 2 of these test: empty can, painful arc, Hawkins
Exclusion criteria:
All contraindication of shock wave History of surgery, fracture or osteoarthritis in the treatment areas
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
AABB; BBAA; ABAB; BABA; ABBA; BAAB. Write these items on six paper and put in the six packets. Draw eight times until eight envelopes are selected, provided that the envelopes are repeated; each characteristics of the specification of the four allocations of the individual.
Blinding (investigator's opinion)
Double blinded
Blinding description
The main researcher in this study won't aware of the randomization of the patients and the patients will treat by another therapist who will aware of the treatment groups. At the end, the data analyst will analyze the data without knowing what treatment package groups 1 and 2 received.
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 Sciences
Street address
Next to Milad Tower, Hemat Highway, Iran University of Medical Sciences.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-07-28, 1401/05/06
Ethics committee reference number
IR.IUMS.REC.1401.446

Health conditions studied

1

Description of health condition studied
Chronic supraspinatus tendinopathy
ICD-10 code
M75.80
ICD-10 code description
Other shoulder lesions, unspecified shoulder

Primary outcomes

1

Description
Range of motion of flexion, abduction, external rotation of the shoulder
Timepoint
At the first and end of treatment program
Method of measurement
Range of motion with inclinometer

2

Description
Strength of the supraspinatus muscle
Timepoint
At the first and end of treatment program
Method of measurement
Muscle strength with dynamometer

3

Description
Pain pressure threshold of the muscles of the supraspinatus, middle deltoid, and upper trapezius.
Timepoint
At the first and end of treatment program
Method of measurement
Pain pressure threshold with algometer

4

Description
Amount of Visual Analog Scale
Timepoint
Before and after each session
Method of measurement
Visual Analog Scale (VAS) questionnaire

5

Description
Quality of life
Timepoint
At the first and end of treatment program
Method of measurement
SF-36 questionner

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:4 session ( one session per week) Extracorporeal Shockwave Therapy(ESWT) Focused Storz ( Swiss 2019) . Protocol: 1000-2000 plus, frequency 4 Hz, intensity 0.1 mj/mm2
Category
Rehabilitation

2

Description
Control group:4 session ( one session per week) Friction massage for 10 minutes on supraspinatus tendon, myofacsial tissue of supraspinatus, deltoid and upper trapezius.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Oxin Physio clinic
Full name of responsible person
Alireza Karimiahmadabadi
Street address
No 11/9., Fakharmoghamad Ave., Dadman Blvd., Sanat Squ.
City
Tehran
Province
Tehran
Postal code
1981619420
Phone
+98 21 2676 7708
Email
physiooxin@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
Web page address
https://en.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
Oxin physiotherapy Clinic
Full name of responsible person
Alireza Karimiahmadabadi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 19., First Boostan street., Fakharmoghadam Ave., Dadman Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619420
Phone
+98 21 2676 7708
Email
Karimi.AR@iums.ac.ir
Web page address
https://oxinphysio.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
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
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
Soheil_Mansour Sohani
Position
Associate professor of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
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
mansorsohani.s@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
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
Loading...