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Comparison of ultrasound guided injection of hyaluronic acid, hyaluronidase enzyme and triamcinolone in the treatment of frozen shoulder

Protocol summary

Study aim
The aim of this study is comparing of the effectiveness of intra-articular injections of hyaluronic acid, hyalase and corticosteroids in reducing pain, improving function, shoulder range of motion, and the level of treatment's satisfaction in patients with frozen shoulder.
Design
A controlled, parallel-group, double blind, randomized, phase 3 clinical trial on 90 patients. Random allocation software is used for randomization.
Settings and conduct
Subjects, interventionist, outcome assessor, statistician and the researcher are all blind to treatment groups allocation; using pre-filled syringes and sealed envelopes. Subjects will be randomly allocated in 3 groups. The study will take place in Modarres hospital, Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: people aged 25 to 70 years who have been diagnosed with adhesive capsulitis and have not responded to conservative treatments and have scored 5 or higher based on pain intensity scale (VAS) and less than 6 months from the onset of symptoms .Exclusion criteria : History of shoulder trauma in the last 6 months; history of humerus fracture or tearing of rotator cuff muscles; pregnancy and breastfeeding; history of shoulder surgery and inflammatory systemic diseases
Intervention groups
Intervention group1: includes 30 patients who are treated with Hyalase injection, 1500 units in 5 cc of normal saline along with 2 cc of 2% lidocaine. Intervention group 2: includes 30 patients who are treated with 2.5 cc of hyaluronic acid with 2.5 cc of normal saline and 2 cc of lidocaine. Control group: includes 30 patients who are treated with injection of 40 mg of triamcinolone along with 4 cc of normal saline and 2 cc of 2% lidocaine.
Main outcome variables
Active range of motion of shoulder, assessment of shoulder pain, assessment of patient's performance in daily tasks and degree of patient's satisfaction.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130523013442N32
Registration date: 2023-09-13, 1402/06/22
Registration timing: prospective

Last update: 2023-09-13, 1402/06/22
Update count: 0
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ultrasound guided injection of hyaluronic acid, hyaluronidase enzyme and triamcinolone in the treatment of frozen shoulder
Public title
Comparison of ultrasound guided injection of hyaluronic acid, hyaluronidase enzyme and triamcinolone in the treatment of frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 25 to 70 years have been diagnosed with adhesive capsulitis based on history and physical examination and did not respond to conservative treatments including non-steroidal pain relievers, exercise therapy and physical modalities. According to VAS criteria, they have scored 5 or higher. More than 30 degrees restriction of shoulder active range of motion in at least 2 of 4 directions of motion (abduction, flexion, external rotation and internal rotation) compared to the range of motion of the healthy shoulder (opposite side). Less than 6 months have passed since the onset of symptoms.
Exclusion criteria:
History of shoulder trauma in the last 6 months History of humerus bone fracture, supraspinatus tear, subacromial bursitis, calcific tendonitis and acromioclavicular joint osteoarthritis Pregnancy and breastfeeding. The presence of nerve injury or the presence of neurological disorders that cause dysfunction of the upper limbs, including brachial plexus plexopathy, hemiplegia and peripheral nerve injury Known allergy or sensitivity to hyalase, hyaluronic acid, or corticosteroids Psychological problems History of shoulder surgery A patient who is unable to cooperate to check the range of motion due to severe pain History of shoulder intra-articular injection of corticosteroids and hyaluronic acid in the last 6 months Inflammatory systemic diseases, hypothyroidism, hyperthyroidism and diabetes Use of anticoagulants
Age
From 25 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial study, 90 patients diagnosed with frozen shoulder will be randomly enrolled. Block randomization method will be used for random allocation of people in the studied groups. In this method, blocks of 9 will be used with a ratio of 1:1:1. Random Allocation software will be used to generate random sequences. For concealment, random allocation concealment method will be used, which is marked with the letters A (Hyalase receiving group), B (Triamcinolone receiving group) and C (Hyaluronic acid receiving group) and recorded on cards. These cards will be placed in the sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then based on The order of entry of the eligible participants, the envelopes will be opened and the assigned group of that participant will be known.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher, patients and the collaborator of the project who will perform ‎the statistical analysis will not be aware of the study . grouping of patients will ‎be noted and will be shared to one of the partners ‎
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-08-09, 1402/05/18
Ethics committee reference number
IR.SBMU.LASER.REC.1402.017

Health conditions studied

1

Description of health condition studied
Adhesive capsulitis or Frozen shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder

Primary outcomes

1

Description
Active range of motion of shoulder
Timepoint
At the beginning of the study (before intervention) and 8 weeks and 24 weeks after the intervention
Method of measurement
Digital goniometer

2

Description
Assessment of shoulder pain
Timepoint
At the beginning of the study (before intervention) and 8 weeks and 24 weeks after the intervention
Method of measurement
Visual analogue scale (VAS)

3

Description
Assessment of the patient's performance in daily tasks
Timepoint
At the beginning of the study (before intervention) and 8 weeks and 24 weeks after the intervention
Method of measurement
Oxford Shoulder Score (OSS)

Secondary outcomes

1

Description
The degree of patient's satisfaction with the treatment
Timepoint
At the beginning of the study (before intervention) and 8 weeks and 24 weeks after the intervention
Method of measurement
5-items questionnaire

Intervention groups

1

Description
Intervention group: Includes 30 patients who are treated with hyalase injection at the rate of 1500 units in 5 cc of normal saline along with 2 cc of 2% lidocaine.
Category
Treatment - Drugs

2

Description
Intervention group: Includes 30 patients who are treated with triamcinolone injection in the amount of 40 mg (one cc) along with 4 cc of normal saline and 2 cc of 2% lidocaine.
Category
Treatment - Drugs

3

Description
Intervention group: Including 30 patients who are treated with 2.5 cc of hyaluronic acid (20 mg per cc) along with 2.5 cc of normal saline and 2 cc of lidocaine
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Shahid Modarres hospital , Kaj Square, Sa'adat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
alin7093@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
a_raeissadat@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Laser Research Center, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Nazari Nodoushan
Position
Resident of Physical medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
alin7093@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
a_raeissadat@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Nazari Noudoshan
Position
Resident of Physical medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
alin7093@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All the data of people participating in this study can be shared after deidentifying people
When the data will become available and for how long
The access period starts one year after the results are published
To whom data/document is available
Data of this study will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers.
From where data/document is obtainable
By sending an email to alin7093@gmail.com
What processes are involved for a request to access data/document
Sending an e-mail and explaining the purpose and how to use the data
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