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Comparison of ultrasound-guided corticosteroid and botulinum toxin in frozen shoulder

Protocol summary

Study aim
The purpose of this study is to evaluate the effectiveness of intra-articular injection of botulinum toxin in reducing pain, improving function and range of motion of the shoulder compared to intra-articular injection of corticosteroids in patients with frozen shoulder.
Design
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 60 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 2 groups of 30 (injection of botulinum toxin with lidocaine or triamcinolone with lidocaine). The study will take place in Modarres hospital, Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria : People aged 30 to 60 years who have been diagnosed with adhesive capsulitis and did not respond to conservative treatments and based on VAS criteria, it should have a score of 5 or higher and 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 fracture; pregnancy and breastfeeding; allergy to botulinum toxin or corticosteroids.; presence of psychological problems; history of shoulder surgery; any intra-articular injection in the involved shoulder within the last 6 months and inflammatory systemic diseases
Intervention groups
Intervention group: Includes 30 patients who are treated with 200 units of botulinum toxin (Masport, Masson Darou) and 1 cc of lidocaine intra-articularly. Control group: Includes 30 patients who are treated with triamcinolone (40 mg intra-articular) with 1 cc of lidocaine.
Main outcome variables
Active range of motion of shoulder, Assessment of shoulder pain, Assessment of the patient's performance in daily tasks

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130523013442N31
Registration date: 2022-12-20, 1401/09/29
Registration timing: registered_while_recruiting

Last update: 2022-12-20, 1401/09/29
Update count: 0
Registration date
2022-12-20, 1401/09/29
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
2022-09-11, 1401/06/20
Expected recruitment end date
2023-06-10, 1402/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ultrasound-guided corticosteroid and botulinum toxin in frozen shoulder
Public title
Comparison of ultrasound-guided corticosteroid and botulinum toxin in frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 30 to 60 years Diagnosed with adhesive capsulitis based on history and physical examination No response to conservative treatments, including non-steroidal anti-inflammatory drugs, opioids, exercise therapy, and physical therapy. A score of 5 or higher based on the intensity of the pain (according to the VAS criteria) Less than 6 months have passed since the onset of the symptoms Have more than 30 degree reduction in the range of motion in at least 2 of the 4 directions of motion (abduction, flexion, external rotation, and internal rotation) compared to the range of motion of the healthy shoulder (opposite side)
Exclusion criteria:
History of shoulder trauma in the last 6 months History of humerus fracture Pregnancy and breastfeeding The presence of nerve damage or neurological disorders that cause dysfunction of the upper limbs, including brachial plexopathy, hemiplegia, and peripheral nerve damage. Allergy or known sensitivity to botulinum toxin or corticosteroids Presence of 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 intra-articular injection in the last 6 months Inflammatory systemic diseases Use of anticoagulants The presence of diseases that involve the connection between nerve and muscle, such as myasthenia gravis and Eaton Lambert
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
in this clinical trial study, 60 patients with a diagnosis of frozen shoulder will be included in the study randomly .For random allocation of individuals in the study groups (intervention or intervention group and comparison or comparison group), the method of random allocation with block method (Block Randomization) will be used In this method, blocks with size of six (including three people in the intervention group and three people in the comparison group) with a ratio of 1: 1 will be used. Random Allocation software will be used to generate random sequences. For concealment, the random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified with two type of cards which are including group a (intervention group) and b (comparison group) and these cards are placed inside 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, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined.
Blinding (investigator's opinion)
Triple 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
Parallel
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
2022-07-24, 1401/05/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.266

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 6 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 6 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 6 weeks and 24 weeks after the intervention
Method of measurement
Oxford Shoulder Score (OSS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Includes 30 patients who are treated with 200 units of botulinum toxin (Masport, Masson Darou) and 1 cc of lidocaine intra-articularly.
Category
Treatment - Drugs

2

Description
Control group: Includes 30 patients who are treated with triamcinolone (40 mg ) with 1 cc of lidocaine (2%) intra-articularly.
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
ali.nazari32@yahoo.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
H-index between 10 and 15 in Scopus
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University of Medical Science
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
ali.nazari32@yahoo.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
Associate 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
ali.nazari32@yahoo.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
No - There is not 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 ali.nazari32@yahoo.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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