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A Comparison between Low Molecular Weight Hyaluronic Acid (Hyalgan® MW= 500-700 KD) and physioytherapy in supraspinatous Tendinopathy.

Protocol summary

Study aim
The aim of this study is evaluating the comparative efficacy and safety of intraarticular space injections of low MW hyaluronic acid and physiotherapy in the shoulder Tendinopathy.
Design
Two parallel proup with randomization performed by computer.not blinded and consists of 56 patients.
Settings and conduct
This study is a randomized, multifaceted, not blind clinical trial The study was performed at Imam Reza Hospital and patients were referred to the hospital again.
Participants/Inclusion and exclusion criteria
Admission: Adults with shoulder tendonitis who are under 65 years of age. Patients with shoulder tendonitis who have had at least 6 weeks and a maximum of three months since the onset of the disease. Lack of entry conditions: Patients with complete tendon rupture diagnosed with MRI. They had a corticosteroid injection less than 3 months ago. Patients with rheumatoid arthritis, multiple sclerosis, ankylosing spondylitis, chemotherapy, fractures and radicular pain in the neck and pregnant women.
Intervention groups
If patients were not barred from injecting hyaluronic acid, they were divided using a table of codes and received one group of intramuscular injections of low molecular weight hyaluronic acid (500-700 kDa) and the other group received physical therapy.
Main outcome variables
Visual Analogue Scale (VAS Score) in three night modes, during activity and rest, Range of Motion (ROM) including Flexion, Extension, Adduction, Abduction, Internal Rotation and External Rotation, Hand Disability Questionnaire, Arm And the shoulder (DASH) and the Qol-bref quality of life questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150118020702N3
Registration date: 2020-06-22, 1399/04/02
Registration timing: retrospective

Last update: 2020-06-22, 1399/04/02
Update count: 0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
mansoure rousta
Name of organization / entity
tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 8691 5234
Email address
m.rousta1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-02-20, 1398/12/01
Scientific title
A Comparison between Low Molecular Weight Hyaluronic Acid (Hyalgan® MW= 500-700 KD) and physioytherapy in supraspinatous Tendinopathy.
Public title
Evaluation of Low Molecular Weight Hyaluronic Acid in treatment of supraspinatous Tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult less than 65 years old with supraspinatous tendinitis Patient with supraspinatous tendinitis who's that between lowermost 6 weeks and uppermost 3 month from initial symptom.
Exclusion criteria:
Patient with complete tendon tearing in MRI study Patient had corticosteroid injection less than 3 month ago. Patient with RA, MS, AS, OP, FX, radicular pain of neck and pregnant women.
Age
To 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 51
Actual sample size reached: 51
Randomization (investigator's opinion)
Randomized
Randomization description
For the random allocation of participants to two groups with the same size of 28 participants (56 patients in total), we used block randomization. Random numbers were generated in an independent statistical room and with the help of a computer.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Army university of medical sciences
Street address
Etemadzadeh St., Army University of Medical Sciences, School of Medicine
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.AJAUMS.REC.1398.253

Health conditions studied

1

Description of health condition studied
Supraspinatous thendinopathy
ICD-10 code
M75.10
ICD-10 code description
Unspecified rotator cuff tear or rupture, not specified as traumatic

Primary outcomes

1

Description
Visual Analogue Scale (VAS Score)
Timepoint
Immediately after the injection, one week, one month, and three months after the injection.
Method of measurement
The patient answer the question of VAS score questionare in 3 modes of rest,activity,and night 3 times after 1week,after1 month and after 3 months of procesure

2

Description
DASH
Timepoint
Immediately after the injection, one week, one month, and three months after the injection.
Method of measurement
The patient answer the question of DASH questionare in 3 times after 1week,after1 month and after 3 months of procesure

3

Description
Quality of life
Timepoint
Immediately after the injection, one week, one month, and three months after the injection.
Method of measurement
The patient answer the questionnare 3 times after 1week,after1 month and after 3 months of procesure.

4

Description
Range of motion( flextion,extention,medial rotation,lateral rotation,abduction,adduction)
Timepoint
Immediately after the injection, one week, one month, and three months after the injection.
Method of measurement
Rom of shoulder of patient in each motion measured by goniometer in 1 week,1 month and 3 month after procedure.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: hyaluronic acid injection performed by physiatrist in tendon.each 2 ml syringe contains hyaluronic acid 20mg. One injection performed with sterility.This drug produced in italy.After injection pleced ice in the site of injection and care rules told to patient.
Category
Treatment - Drugs

2

Description
Intervention group2: in this group patient underwent physiotherapy.physiotherapy contains US,TENS and exercise.10 set of physiotherapy performed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital 501
Full name of responsible person
Mansoure Rousta
Street address
Etemadzade
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
m.rousta1991@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza soltani Zahra
Street address
Etemadzade
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
m.rousta1991@gmail.com
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
Mansoure Rousta
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Etemadzade
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8601 3867
Email
m.rousta1991@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mansoure Rousta
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Etemadzade
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8601 3867
Email
m.rousta1991@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mansoure Rousta
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Tehran-Poorsina st
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8691 5234
Fax
+98 21 8601 5234
Email
m.rousta1991@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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