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The effect of Methylprednisolone and Betamethasone on the treatment of lateral epicondylitis in patients referred to Shafaihiaian and Rasoul Akram hospitals in Tehran in 2025;A randomized clinical trial study

Protocol summary

Study aim
The effect of Betamethasone and Methylprednisolone on the treatment of Lateral Epicondylitis
Design
patients are randomly divided into two groups of 18 individuals each. The corticosteroid injections are administered as a single dose. The follow-up duration for patients is 2, 6, and 12 weeks.
Settings and conduct
Patients presenting to the outpatient clinics of Rasool Akram and Shafa Yahyayan Hospitals during the year 2025, who meet the study inclusion criteria and are diagnosed cases of lateral epicondylitis with symptoms lasting between one to six months, will be enrolled in the study. Participants will then be sequentially assigned into two study groups based on pain severity and age. Both the patients and the questionnaire administrator will be blinded to the type of injectable medication administered. Patients will only be informed about the types of medications being used in the study (without knowing which one they receive). Study questionnaires will be completed before the intervention and subsequently at 2, 6, and 12 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age range : 25 and 60 years Pain intensity ≥ 5 Written informed consent No local interventions such as PRP and no use of NSAIDs, brace, or physiotherapy within 2 m before the start of the study Exclusion Criteria: systemic inflammatory diseases, fibromyalgia syndrome, cervical radiculopathy, or peripheral neuropathy in the upper limb hypersensitivity to corticosteroids ipsilateral medial epicondylitis Ipsilateral carpal tunnel syndrome Pregnancy or lactation History of elbow fracture Coagulation disorders Psychological disorders Presence of a cardiac pacemaker
Intervention groups
A- Methylprednisolone injection B- Betamethasone injection
Main outcome variables
Visual analog scale Quick Disabilities of the Arm, Shoulder and Hand Patient-Rated Tennis Elbow Evaluation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190610043858N1
Registration date: 2026-04-20, 1405/01/31
Registration timing: retrospective

Last update: 2026-04-20, 1405/01/31
Update count: 0
Registration date
2026-04-20, 1405/01/31
Registrant information
Name
Amir Saberi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 9126 7823
Email address
amirsaberi20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-15, 1404/04/24
Expected recruitment end date
2026-03-14, 1404/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Methylprednisolone and Betamethasone on the treatment of lateral epicondylitis in patients referred to Shafaihiaian and Rasoul Akram hospitals in Tehran in 2025;A randomized clinical trial study
Public title
The effect of Methylprednisolone and Betamethasone on the treatment of lateral epicondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with lateral epicondylitis: individuals who, within one to six months prior to entering the study, meet at least two diagnostic criteria in the lateral elbow and forearm region, including tenderness over the lateral epicondyle, positive Cozen’s test: pain occurring in the lateral elbow and forearm during wrist extension against resistance, positive Moudley test: pain occurring in the lateral elbow and forearm during middle finger extension against resistance, positive Chair test: pain occurring in the lateral elbow while lifting a heavy object weighing approximately 3 to 5 kilograms. Age range between 25 and 60 years Pain intensity greater than or equal to 5 based on the Visual Analog Scale (VAS) Obtaining written informed consent No receipt of local interventions such as PRP injections for the treatment of lateral epicondylitis within one to six months prior to study entry No use of NSAIDs, braces, or physiotherapy for the treatment of lateral epicondylitis within two weeks prior to the start of the study
Exclusion criteria:
Patients with systemic inflammatory diseases, fibromyalgia syndrome, cervical radiculopathy, or peripheral neuropathy in the upper limb History of allergy to corticosteroids Ipsilateral medial epicondylitis Ipsilateral carpal tunnel syndrome Pregnancy and breastfeeding History of elbow fracture Coagulation disorders or use of anticoagulant medications Patients with psychological disorders Presence of a cardiac pacemaker
Age
From 25 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 36
More than 1 sample in each individual
Number of samples in each individual: 0
One or two elbows of a patient
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients are distributed into study groups based on pain intensity and age. Specifically, individuals are categorized by age into two groups: ≤ 40 years and > 40 years. Regarding pain intensity, based on the VAS scale, individuals are categorized into two blocks: ≤ 7 and > 7. They are then sequentially and consecutively assigned to study groups A and B. Individuals aged ≤ 40 years are classified into the above pain intensity categories (Block A and Block B), while individuals aged > 40 years are classified into the same pain intensity categories (Block C and Block D). These categories are labeled with the corresponding Persian letters in the checklist, so the distribution of patients across groups is symbolically represented to maintain consistency.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants are unaware of the type of injectable medication being used. Additionally, a trained orthopedic resident who collects data before and after the intervention is also unaware of the type of intervention being performed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine, Iran university of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2025-07-13, 1404/04/22
Ethics committee reference number
IR.IUMS.FMD.REC.1404.207

Health conditions studied

1

Description of health condition studied
Lateral epicondylitis
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis

Primary outcomes

1

Description
pain intensity
Timepoint
before and at 2, 6, and 12 weeks after the intervention
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
individual's daily function
Timepoint
before and at 2, 6, and 12 weeks after the intervention
Method of measurement
quick DASH , Patient-Rated Tennis Elbow Evaluation (PRTEE)

Intervention groups

1

Description
Intervention group: A- Local injection of Methylprednisolone (40 mg/mL – Iran Hormone Company) administered at the tendinoperiosteal site approximately 2 cm inferior and anterior to the lateral epicondyle, aligned with the point of maximum tenderness
Category
Treatment - Drugs

2

Description
Intervention group: Local injection of Betamethasone (4 mg/mL – Aburaihan Company) administered at the tendinoperiosteal site approximately 2 cm inferior and anterior to the lateral epicondyle, aligned with the point of maximum tenderness
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasoul Akram Hospital and Shafa Yahyaian Hospital, Te
Full name of responsible person
AMIR SABERI
Street address
SATTAR KHAN- NIAYESH AVE.
City
TEHRAN
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6435 1000
Email
amirsaberi20@gmail.com

2

Recruitment center
Name of recruitment center
Shafa Yahyaian houspital
Full name of responsible person
AMIR SABERI
Street address
Baharestan Square, Mojahedin-e-Islam Street
City
TEHRAN
Province
Tehran
Postal code
1157637131
Phone
+98 21 3848 7000
Fax
+98 21 3848 7000
Email
amirsaberi20@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
AMIR SABERI
Street address
Sattar Khan, Niayesh Street
City
TEHRAN
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6435 1000
Email
amirsaberi20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Amir Saberi
Position
Md
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sattar Khan, Niayesh Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6435 1000
Fax
Email
amirsaberi20@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amir Saberi
Position
Md
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sattar Khan, Niayesh Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6435 1000
Fax
Email
amirsaberi20@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Saberi
Position
Md
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sattar Khan, Niayesh Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6435 1000
Fax
Email
amirsaberi20@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
Maintaining research ethics
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
no data
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
Comments
-
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