The aim of this study is to evaluate the effect of radial shock wave therapy in non-calcified shoulder tendinopathy compared with corticosteroid injection.
Design
The study is a clinical trial single-blinded (analyzers and assessor) study and the sampling is with a simple randomization method. The study population is 36 patients.
Settings and conduct
Patients will be randomly divided into two groups of eighteen.The research was carried out in physical medicine and rehabilitation clinic at Firoozgar hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
- Shoulder tendinopathy as a positive result of specific tests like Neer & Hawkins test.
- Visual analog scale above 4 (VAS>4).
- The willingness of the patients to participate in the research projects.
- Not having shoulder injection in the last 4 months.
- Age between 18 and 65 years.
- Not being pregnant or having the decision to become pregnant.
- The absence of intraarticular injection contraindications such as coagulation disorders or taking anticoagulant medicine.
- Having pain for more than 3 months.
Exclusion criteria:
- Having any kind of mental illness.
- Previous history of rotator cuff tear, diabetes, coagulation disorders, fractures, rheumatologic diseases, tumors, and infection.
Intervention groups
Control group:1 cc equal 40 mg triamcinolone with 2 cc of lidocaine using 22 gauge needle under ultrasound guidance (lateral approach) will be injected in the subacromial space.
The intervention group will receive three sessions of radial shock wave with Storz device in three consecutive weeks with 2000 pulses of energy and 4 Hz frequency.
Main outcome variables
Pain by Visual Analog Scale and functional ability using Quick DASH questionnaire will be measured before the treatment, two weeks after the treatment and three months later.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181122041727N1
Registration date:2019-12-02, 1398/09/11
Registration timing:prospective
Last update:2019-12-02, 1398/09/11
Update count:0
Registration date
2019-12-02, 1398/09/11
Registrant information
Name
Negar Aflakian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1229
Email address
aflakian.n@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-11, 1398/09/20
Expected recruitment end date
2020-02-09, 1398/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of single session ultrasound-guided corticosteroid injection and radial shock wave therapy in non-calcified shoulder tendinopathy.
Public title
The effects of corticosteroid injection and radial shock wave in the shoulder inflammatory disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Shoulder tendinopathy as a positive result of specific tests like Neer & Hawkins test.
Visual analog scale above 4 (VAS>4).
The willingness of the patients to participate in the research projects.
Not having shoulder injection in the last 4 months.
Age between 18 and 65 years.
Not being pregnant or having the decision to become pregnant.
The absence of intraarticular injection contraindications such as coagulation disorders or taking anticoagulant medicine.
Having pain for more than 3 months.
Exclusion criteria:
Having any kind of mental illness.
Previous history of rotator cuff tear, diabetes, coagulation disorders, fractures, rheumatologic diseases, tumors, and infection.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization, in which each member of the community has an equal chance of being independent, is chosen. The randomization method will be used with random and binary blocks. Regarding the sample size of 36 people, 9 quadruple blocks will be generated and numbered using the permutations method. Using the random number table, blocks will be placed together to form a patient allocation sequence to treatment groups. Providers will be unaware of the type of treatment that will be received, as well as the random sequences generated in the length of the study will be unpredictable.
Blinding (investigator's opinion)
Single blinded
Blinding description
1- The outcome assessor, would not be aware of the allocation when assessing the patients in the measuring time points.
2-The data analyzer, would not be aware of the allocation when analyzing.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran Universiy of Medical Science
Street address
Medical faculty, Iran University of Medical Sience, Hemmat High way
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.IUMS.FMD.REC.1397.078
Health conditions studied
1
Description of health condition studied
Shoulder tendinopathy
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
The severity of symptoms
Timepoint
Before treatment, two weeks and three months after the end of treatment
Method of measurement
Visual Analog Scale (VAS)
2
Description
The amount of physical performance
Timepoint
Before treatment, two weeks and three months after the end of treatment
Method of measurement
Quick DASH questionnaire ( Quick Disabilities of Arm, Shoulder & Hand )
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 1 cc equal 40 mg triamcinolone(Exir Pharmaceutical Company, made in Iran) with 2 cc of 2% lidocaine(Caspian Tamin Pharmaceutical Company, made in Iran) using 22 gauge needle under ultrasound guidance (lateral approach) will be injected in the subacromial space as conventional treatment.
Category
Treatment - Other
2
Description
The intervention group will receive three sessions of radial shock wave in three consecutive weeks with 2000 pulses of energy and 4 Hz frequency. Shock wave device, Storz Medical company, Swiss-made will be used.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Educational Hospital
Full name of responsible person
Dr. Arash Babaei
Street address
Physical medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St, Karim Khane Zand St, Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1229
Fax
Email
babaei-ghazani.a@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Abas Motovalian
Street address
5th floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4704
Fax
+98 21 8862 2707
Email
amotevalian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Negar Aflakian
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St, Karim Khane Zand St, Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1229
Email
aflakian.n@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Arash Babaei
Position
Associate Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St, Karim Khane Zand St, Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1229
Email
babaei-ghazani.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Negar Aflakian
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St, Karim Khane Zand St, Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1229
Email
aflakian.n@tak.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