comparison of the safety and efficacy of botulinum toxin A injection combined with corticosteroids with corticosteroids with palcebo in the treatment of patients with supraspinatus tendinopathy
Evaluation and comparison of the safety and efficacy of botulinum toxin A injection with corticosteroids and corticosteroids with placebo in the treatment of patients with supraspinatus tendinopathy
Design
A controlled clinical trial with parallel groups, double-blind, randomized, on 20 patients. Random allocation software will be used for randomization.
Settings and conduct
Study location: Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran; Study population: Patients with shoulder pain and limited range of motion diagnosed with supraspinatus tendinopathy; Type of blinding: Double-blind; Method of blinding: Failure to inform the patient and therapist about the contents of the injection syringe, which are identical in color and appearance
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 20 to 70 years; confirmation of symptoms of supraspinatus tendinopathy in clinical examination and ultrasound. Exclusion criteria: History of trauma to the hand and shoulder area; complete supraspinatus tear; pregnancy and lactation; history of sensitivity to corticosteroids and botulinum toxin; concomitant frozen shoulder disease
Intervention groups
Intervention group: Patients with supraspinatus tendinopathy who receive corticosteroid and botulinum toxin injections as first line treatment.
Control group: Supraspinatus tendinopathy patients who receive corticosteroid injections and placebo as first-line treatment.
Main outcome variables
Pain intensity, range of motion, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240729062578N2
Registration date:2026-01-27, 1404/11/07
Registration timing:prospective
Last update:2026-01-27, 1404/11/07
Update count:0
Registration date
2026-01-27, 1404/11/07
Registrant information
Name
Mahboobe Ghanbarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 4450
Email address
mahboobeghanbarian313@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-24, 1404/12/05
Expected recruitment end date
2026-03-21, 1405/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the safety and efficacy of botulinum toxin A injection combined with corticosteroids with corticosteroids with palcebo in the treatment of patients with supraspinatus tendinopathy
Public title
Safety and effectiveness of Botox injections combined with cortisone in shoulder tendon problems
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with supraspinatus tendinopathy
Confirmation of the problem by examination and ultrasound
Not having previously received treatment
Intervention should be carried out as a first line
Age between 20-70 years
Exclusion criteria:
History of trauma to the hand and shoulder area in the last 6 months
History of humerus fracture
Complete rupture of the supraspinatus tendon
Acromioclavicular joint osteoarthritis
Calcific tendonitis
Pregnancy and breastfeeding
Presence of nerve damage or neurological disorders that cause upper limb dysfunction
The existence of psychological problems
History of shoulder surgery
Patient's lack of cooperation in assessing range of motion
History of corticosteroid injection into the shoulder within the past 6 months
Concomitant radiculopathy
Coincidence with frozen shoulder
Systemic inflammatory diseases
History of sensitivity to botulonium toxin
History of sensitivity to corticosteroid
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 20 patients with supraspinatus tendinopathy will be enrolled in a simple randomization study. To randomly assign individuals to the study groups (intervention group and comparison group), a block randomization method will be used. In this method, blocks of 2 (including one person in the intervention group and one person in the comparison group) will be used in a 1:1 ratio. Random Allocation software will be used to generate random sequences. Individuals will be divided into two intervention groups (10 people) and a control group (10 people). In the intervention group, 30 units of botulinum toxin A along with 40 units of steroid will be injected into the tendon sheath of the supraspinatus muscle. In the control group (placebo), 30 units of normal saline will be injected into the supraspinatus muscle and 40 units of steroid will be injected into the tendon sheath of the supraspinatus muscle. The injecting physician will not know about the substance injected into the muscle. Patients are also aware of the study conditions before the study, but during the study they do not know which group they are in and whether they will receive botulinum toxin in addition to the corticosteroid.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because there is no difference in volume, color, or appearance between normal saline and botulinum toxin, there is no need to cover the syringe Information about the contents of the syringe is not given to the patient or therapist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Koodakya Alley, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2025-10-23, 1404/08/01
Ethics committee reference number
IR.SBMU.RETECH.REC .1404.163
Health conditions studied
1
Description of health condition studied
Supraspinatus tendinopathy
ICD-10 code
M75.9
ICD-10 code description
Shoulder lesion, unspecified
Primary outcomes
1
Description
Shoulder range of motion
Timepoint
Before injection,1and 3 months later
Method of measurement
Physical exam and questioner
2
Description
Shoulder pain
Timepoint
Before injection,1and 3 months later
Method of measurement
Questioner
Secondary outcomes
1
Description
Quality of life
Timepoint
Before injection,1and 3months later
Method of measurement
Questioner
Intervention groups
1
Description
Intervention group: One injection of 30 units of Dysport into the supraspinatus muscle and 40 mg of methylprednisolone into the bursa of the supraspinatus tendon sheath once
Category
Treatment - Drugs
2
Description
Control group: one injection of 40 mg of methylprednisolone into the bursa of the supraspinatus tendon sheath and 30 units of normal saline into the supraspinatus muscle once
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish hospital
Full name of responsible person
Seyed Mansoor Raygani ,MD
Street address
Darband Alley, Shahrdari Street
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2222 3355
Email
mahboobeghanbarian313@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Darband Alley, Shahrdari Street
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2352 3710
Email
mahboobeghanbarian313@gmail.com
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
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
Seyed Mansoor raygani
Position
Director of the Department of Physical Medicine and Rehabilitation, Shahid Beheshti University of Me
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Darband Alley, Shahrdari Street
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2352 3710
Email
mahboobeghanbarian313@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mansoor raygani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shohadaye Tajrish Hospital, Darband Avenue, Shahrdari Street
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2352 3710
Fax
+98 21 2352 3711
Email
mahboobeghanbarian313@gmail.com
Web page address
https://sbmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobe Ghanbarian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Darband Alley, Shahrdari Street
City
Tehran
Province
Tehran
Postal code
قبلی
Phone
قبلی
Email
mahboobeghanbarian313@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
Patients are unwilling to disclose their information.
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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