Comparison of the Effectiveness of routine Physiotherapy and Rehabilitation with Periarticular Prolotherapy with Dextrose in Patients with Rotator Cuff Tendonitis
Comparison of the Effectiveness of routine Physiotherapy and Rehabilitation with Periarticular Prolotherapy with Dextrose in Patients with Rotator Cuff Tendonitis
Design
Clinical trial with control group,parallel group trial with single blinded outcome assessment, Randomised
Settings and conduct
The clinical trial is done at Tehran-Emam Reza Hospital, Patients with Rotator Cuff Tendonitis are randomisedly divided into two groups of intervention (Periarticular Prolotherapy with Dextrose 12.5%) and control (physiotherapy).Outcome assessments based on the Visual scale of pain (VAS)and the Shoulder Pain and Disability Index (SPADI) questionnaire are performed before the intervention, one week and one month later.The study is single blind and result's evaluator is kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients aged 18-65 years with Rotator Cuff Tendonitis;
Exclusion criteria:Patients with malignancy or Diabetes mellitus or complete rotator cuff tear
Intervention groups
Intervention group: Periarticular Prolotherapy with Dextrose 12.5% and control; group: physiotherap for Rotator Cuff Tendonitis
Main outcome variables
Visual scale of pain;Pain and disability severity based on Shoulder Pain and Disability Index questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181217042028N1
Registration date:2019-04-13, 1398/01/24
Registration timing:retrospective
Last update:2019-04-13, 1398/01/24
Update count:0
Registration date
2019-04-13, 1398/01/24
Registrant information
Name
Fatemeh Abdorrazaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 1827
Email address
rezasoltani@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-31, 1397/11/11
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of routine Physiotherapy and Rehabilitation with Periarticular Prolotherapy with Dextrose in Patients with Rotator Cuff Tendonitis
Public title
Effect of Periarticular Prolotherapy with Dextrose in Patients with Rotator Cuff Tendonitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Rotator Cuff Tendonitis
Exclusion criteria:
History of Diabetes Mellitus
History of Malignancy
Complete rotator cuff tear
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
One or two shoulder
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Result's evaluators are kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee AJA University of Medical Sciences
Street address
Emam Reza hospital, Etemad zade Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-12-23, 1397/10/02
Ethics committee reference number
IR.AJAUMS.REC.1397.069
Health conditions studied
1
Description of health condition studied
Rotator Cuff Tendonitis
ICD-10 code
M75.11
ICD-10 code description
Incomplete rotator cuff tear or rupture not specified as traumatic
Primary outcomes
1
Description
Pain and disability severity based on Shoulder Pain and Disability Index questionnaire
Timepoint
Before the intervention, one week and a month later
Method of measurement
Shoulder Pain and Disability Index questionnaire
2
Description
Pain severity based on Visual Analogue Scale
Timepoint
Before the intervention, one week and a month later
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Periarticular Prolotherapy with 12.5 % Dextrose
Category
Treatment - Drugs
2
Description
Control group: Physiotherapy and Rehabilitation(10 Sessions)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Zahra Rezasoltani
Street address
Emam Reza hospital, Etemad zade Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
z.rezasoltani@ajaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mostafa Shahrezai
Street address
AJA university of medical science, Etemad zade Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
z.rezasoltani@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Zahra Rezasoltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza hospital, Etemad zade Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
z.rezasoltani@ajaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Zahra Rezasoltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza hospital, Etemad zade Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
z.rezasoltani@ajaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Fatemeh Abdorrazaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Emam reza hospital,Etemadzade St,West Fatemi St
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 6652 1827
Fax
Email
rezasoltani@ajaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information on the main outcome, can be shared.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Only available to scholars working in universities and academia.
Under which criteria data/document could be used
Only for doing research
From where data/document is obtainable
You can contact Zahra Rezasoltani by e-mail to z.rezasoltani@ajaums.ac.ir.
What processes are involved for a request to access data/document
His/her request must first be submitted to the Physical Medicine and Rehabilitation Department of the Army Medical University.If approved, the legal process should be continued through the relevant authorities at the university.