IRCT | Evaluating the effect of subacromial space injections of Low Molecular Weight Hyaluronic Acid or High Molecular Weight Hyaluronic Acid in comparison with Physiotherapy in Shoulder Tendinopathy. A Three Arm Randomized Controlled Trial.

Protocol summary

Study aim: Evaluating the effect of subacromial space injections of low molecular weight hyaluronic acid or high molecular weight hyaluronic acid in comparison with physiotherapy in shoulder tendinopathy.
Design: Single center, randomized, blinded, phase III clinical trial with a parallel group design of 84 participants with shoulder tendinopathy, equally divided in to three groups, low MW hyaluronic acid, high MW hyaluronic acid and Physiotherapy.
Settings and conduct: Follow-up assessors, statistical data analyzers, and quality controllers are blinded. The injectors and physiotherapist have been excluded from the study and the interventions performed based on the codes provided in a sealed packages.
Participants/Inclusion and exclusion criteria: Participants will be adult patients (16-70 years old) with Shoulder Tendinopathies, with onset of shoulder pain for least 6 weeks . Pediatrics, geriatrics, pregnant, lactating, patient with active rheumatologic disorders, patient with coagulopathies, active infections in shoulder and tissues of around the shoulder, complete rupture of rotator cuff tendons, diabetes mellitus, use of anticoagulant drugs, use of systemic corticosteroid in the last month will be excluded from the study.
Intervention groups: Participants randomly divided in three groups of intervention, first group received low MW hyaluronic acid (Hyalgan®), the second group received high MW hyaluronic acid (Synogel®) and the third group received Physiotherapy.
Main outcome variables: The primary outcome is Visual Analog Scale (VAS). The secondary outcomes will be: 1) the range of motions (ROM) in flexion, extension, abduction, adduction, internal and external rotation, 2) Disability of the Arm Shoulder and Hand (DASH) Questionnaire, 3) Quality Of Life (WHOQOL)-BREF.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20170608034390N7

Registration date: 2021-01-18, 1399/10/29

Registration timing: retrospective

Last update: 2021-01-18, 1399/10/29

Update count: 0
Registration date: 2021-01-18, 1399/10/29

Registrant information: Name

Hadi Esmaily

Name of organization / entity

SBMU

Country

Iran (Islamic Republic of)

Phone

+98 21 8887 3704

Email address

esmaily_hadi@sbmu.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-10-08, 1397/07/16
Expected recruitment end date: 2019-09-23, 1398/07/01
Actual recruitment start date: 2018-12-07, 1397/09/16
Actual recruitment end date: 2020-08-16, 1399/05/26
Trial completion date: 2020-12-21, 1399/10/01

Scientific title: Evaluating the effect of subacromial space injections of Low Molecular Weight Hyaluronic Acid or High Molecular Weight Hyaluronic Acid in comparison with Physiotherapy in Shoulder Tendinopathy. A Three Arm Randomized Controlled Trial.

Public title: Comparison between effectiveness of two different molecular weights of hyaluronic acid and physiotherapy on shoulder tendinopathy.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Tendinopathy of shoulder Adults (16-70 years) At least 6 weeks from the onset of pain

Exclusion criteria:

Pregnant or lactating Women Active systemic rheumatologic disorders Coagulopathies or on anticoagulant medication Diabetes mellitus Active septic disorders or history of cancers or tumors around the site of shoulder joint Use of systemic corticosteroid drugs recently in one month
Age: From 16 years old to 70 years old
Gender: Both

Phase

3

Groups that have been masked

Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board

Sample size

Target sample size: 84

Actual sample size reached: 68

Randomization (investigator's opinion)

Randomized

Randomization description

Patients were divided with the same ratio in three groups and a web base software (www.sealedenvelope.com) was applied and 14 blocks of 6 subjects were created for block randomization.

Blinding (investigator's opinion)

Triple blinded

Blinding description

Researchers including the physician who assess the eligibility of patients, the physician who monitors response to interventions, the statistical analyst, and the controller of study quality, were all blinded, but due to the different nature of interventions, it was not possible to blind the administrants, in this regards a sealed envelope containing the patient's treatment code was sent to injector and physiotherapist who only administered the interventions based on the codes, and they were excluded from the patient eligibility, treatment and outcome assessments. Since one of the interventions was physiotherapy, it was not possible to blind patients.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committee School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of

Street address

Central department of ministry of health and medical education, Simaye Iran st, Shahrak Ghods

City

Tehran

Province

Tehran

Postal code

1467664961
Approval date: 2018-10-08, 1397/07/16
Ethics committee reference number: IR.SBMU.PHARMACY.REC.1397.130

Health conditions studied

1

Description of health condition studied: shoulder tendinophaty(Rotator cuff tendinopathy)
ICD-10 code: M75.80
ICD-10 code description: Other shoulder lesions, unspecified shoulder

Primary outcomes

1

Description: Pain intensity based on visual analogue scale
Timepoint: Measuring the severity of pain at the beginning of the study (before the intervention), one week, one month and three months after the injection.
Method of measurement: Visual Analogue Scale (VAS)

Secondary outcomes

1

Description: Range of Motion (ROM)
Timepoint: Measuring the range of motion at the beginning of the study (before the intervention), one week, one month and three months after the injection.
Method of measurement: Goniometer

2

Description: Pain of the injection site
Timepoint: Check for the pain at the injection site, one day after injection
Method of measurement: Visual Analogue Scale (VAS)

3

Description: The disabilities of the arm, shoulder and hand
Timepoint: Measuring the disabilities of the arm, shoulder and hand at the beginning of the study (before the intervention), one week, one month and three months after the injection.
Method of measurement: The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

4

Description: Quality of life
Timepoint: Measuring the Quality of life at the beginning of the study (before the intervention), one week, one month and three months after the injection.
Method of measurement: QOL-BREF Questionnaire

Intervention groups

1

Description: Intervention group: High MW of Hyaluronic acid (Synogel® MW>2000 KD) injection in subacromial space of shoulder with Codman's (pendulum) Exercises
Category: Treatment - Drugs

2

Description: Intervention group: Low MW of Hyaluronic acid (Hyalgan® MW= 500-700 KD) injection in Subacromial space of shoulder with Codman's (pendulum) Exercises
Category: Treatment - Drugs

3

Description: Intervention group: For the Physiotherapy group, it prescribed 3 sessions of treatment per week for 4 weeks, totaling 10 sessions, with Codman's (pendulum) Exercises
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Imam Reza Hospital, 501 Army

Full name of responsible person

Zahra Reza Soltani

Street address

Imam Reza Hospital, 501 Army_ Shahid Etemadzadeh St_West Fatemi Ave_Tehran

City

Tehran

Province

Tehran

Postal code

88028724

Phone

+98 21 8609 6931

Email

z.rezasoltani@ajaums.ac.ir

1

Sponsor: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Afshin Zarghi

Street address

Shahid Beheshti University of Medical Sciences, Taleghani Hospital, Shahid Arabi Ave, Yemen Ave, Shahid Chamran Highway

City

Tehran

Province

Tehran

Postal code

1985717443

Phone

+98 21 2243 9780

Email

zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shahid Beheshti University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Private
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

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Hadi Esmaily

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Medical Pharmacy

Street address

Shahid Beheshti Pharmaceutical Faculty, Vali Asr Ave.

City

Tehran

Province

Tehran

Postal code

1991953381

Phone

+98 21 8820 0118

Email

Esmaily_hadi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Hadi Esmaily

Position

Assistant

Latest degree

Specialist

Other areas of specialty/work

Medical Pharmacy

Street address

Shahid Beheshti Pharmaceutical Faculty, Vali Asr Ave.

City

Tehran

Province

Tehran

Postal code

1991953381

Phone

+98 21 8820 0118

Email

Esmaily_hadi@sbmu.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Rezvaneh Mohebbi

Position

Student

Latest degree

Medical doctor

Other areas of specialty/work

Medical Pharmacy

Street address

Shahid Beheshti Pharmaceutical Faculty, Vali Asr Ave

City

Tehran

Province

Tehran

Postal code

1991953381

Phone

+98 21 8820 0118

Email

rzvnhmhbbi@gmail.com

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: 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: Yes - There is 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
Title and more details about the data/document: Potentially the whole data is published after participants become unidentified.
When the data will become available and for how long: The access Starts in 6 months period after publishing of the results.
To whom data/document is available: Researchers working in academic and industrial institutions.
Under which criteria data/document could be used: It can be used to carry out research work.
From where data/document is obtainable: Dr. Hadi Esmaily, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences.
What processes are involved for a request to access data/document: It will be available with sending a request by email to corresponding author (Esmaily_hadi@sbmu.ac.ir).
Comments

Evaluating the effect of subacromial space injections of Low Molecular Weight Hyaluronic Acid or High Molecular Weight Hyaluronic Acid in comparison with Physiotherapy in Shoulder Tendinopathy. A Three Arm Randomized Controlled Trial.