1. Home
  2. Approved trials
  3. » فارسی

Evaluation of the Effectiveness and Safety of Imipenem/Cilastatin Transarterial Embolization for Reducing Pain and Improving Shoulder Function in Patients with Treatment-Resistant Adhesive Capsulitis: A Single-Arm Pilot Clinical Trial

Protocol summary

Study aim
To evaluate the effectiveness and safety of transarterial embolization using imipenem/cilastatin in patients with treatment-resistant adhesive capsulitis.
Design
Single-arm, pre–post pilot clinical trial without randomization or a control group, with blinded outcome assessment, conducted in 17 patients. The study is designed as a pilot trial, and no clinical trial phase is applicable.
Settings and conduct
Eligible patients will undergo transarterial embolization using imipenem/cilastatin at the Radiology Department of Imam Khomeini Hospital and will be followed for 6 months to assess the effectiveness and safety of the intervention.
Participants/Inclusion and exclusion criteria
Patients with treatment-resistant adhesive capsulitis. Inclusion Criteria: Age 18–75 years. Clinical diagnosis of adhesive capsulitis with limited active and passive shoulder motion. Refractory to ≥3 months of standard conservative treatment (physiotherapy, NSAIDs, and ≤1 intra-articular corticosteroid injection). <30% improvement in VAS or <20° improvement in shoulder flexion or abduction. Imaging excluding full-thickness rotator cuff tear, advanced osteoarthritis, or avascular necrosis. Exclusion Criteria: Active infection. Uncorrectable coagulation disorder. Severe allergy to contrast media or beta-lactam antibiotics. Pregnancy or breastfeeding. Severe vascular disease precluding safe catheterization. Presence of other shoulder disorders, including fracture, inflammatory arthritis, or malignancy. Inability to provide informed consent or comply with follow-up.
Intervention groups
Single intervention group: All participants will undergo transarterial embolization using imipenem/cilastatin.
Main outcome variables
VAS Constant–Murley ROM

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250715066507N2
Registration date: 2026-08-20, 1405/05/29
Registration timing: prospective

Last update: 2026-08-20, 1405/05/29
Update count: 0
Registration date
2026-08-20, 1405/05/29
Registrant information
Name
Hamed Ghorani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 8012
Email address
h-ghorani@razi.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-03, 1405/06/12
Expected recruitment end date
2027-08-03, 1406/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness and Safety of Imipenem/Cilastatin Transarterial Embolization for Reducing Pain and Improving Shoulder Function in Patients with Treatment-Resistant Adhesive Capsulitis: A Single-Arm Pilot Clinical Trial
Public title
Evaluation of the Efficacy and Safety of Arterial Embolization Using Imipenem/Cilastatin in the Management of Treatment-Resistant Adhesive Capsulitis of the Shoulder: A Single-Arm Pilot Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 75 Clinical diagnosis of adhesive capsulitis with limitation of both active and passive shoulder range of motion, particularly external rotation. Failure to respond to at least 3 months of standard conservative treatment, including structured physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), and a maximum of one intra-articular corticosteroid injection.Less than 30% improvement in pain severity (VAS) or less than 20° improvement in shoulder flexion or abduction range of motion compared with baseline Imaging performed to exclude other shoulder pathologies, such as full-thickness rotator cuff tear, advanced osteoarthritis, or avascular necrosis.
Exclusion criteria:
Active infection. Uncorrectable coagulation disorder Severe allergy to contrast media or beta-lactam antibiotics. Pregnancy or breastfeeding. Severe vascular disease precluding safe catheterization. Presence of other shoulder disorders, including fracture, inflammatory arthritis, or malignancy Inability to provide informed consent or comply with follow-up.
Age
From 18 years old to 75 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 17
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of the Center of Elites and Talents of the Armed Forces
Street address
No. 182, Shahid Beheshti School of Governance, corner of Shohada Street, Ghaem Magham Farahani Street, Shahid Beheshti Street, Tehran 1586755414, Iran.
City
Tehran
Province
Tehran
Postal code
1586755414
Approval date
2026-08-02, 1405/05/11
Ethics committee reference number
IR.SBMU.TEB.POLICE.REC.1405.017

Health conditions studied

1

Description of health condition studied
Treatment-resistant adhesive capsulitis of the shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder

Primary outcomes

1

Description
Shoulder pain severity
Timepoint
Baseline (pre-intervention), 1 month, 3 months, and 6 months post-intervention.
Method of measurement
Pain severity will be assessed using the Visual Analog Scale (VAS).

2

Description
Shoulder function
Timepoint
Baseline (pre-intervention), 1 month, 3 months, and 6 months post-intervention.
Method of measurement
Shoulder function will be assessed using the Constant–Murley Score (CMS).

3

Description
Shoulder range of motion (ROM)
Timepoint
Baseline (pre-intervention), 1 month, 3 months, and 6 months post-intervention.
Method of measurement
Shoulder range of motion (flexion, abduction, and external rotation) will be measured using a goniometer.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: All eligible participants will undergo transarterial embolization using imipenem/cilastatin. The procedure will be performed by an interventional radiologist to embolize the pathological arterial branches supplying the shoulder joint capsule.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Radiology Department, Imam Khomeini Hospital
Full name of responsible person
Hamed Ghorani
Street address
Department of Radiology, Imam Khomeini Hospital Complex, Dr. Gharib Street, Keshavarz Boulevard, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2304
Email
Imamhospital@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Center of Elites and Top Talents, Law Enforcement Command of the Islamic Republic of Iran (FARAJA)
Full name of responsible person
سیروس افشار
Street address
Shahid Khalilzadeh Military Base, Shahid Sayyad Shirazi Expressway, south of Resalat Square, Tehran, Iran.
City
Tehran, Iran.
Province
Tehran
Postal code
1586755414
Phone
+98 21 8199 2786
Email
info@mneb.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Center of Elites and Top Talents, Law Enforcement Command of the Islamic Republic of Iran (FARAJA)
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
Tehran University of Medical Sciences
Full name of responsible person
Hamed Ghorani
Position
Radiologist
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
No. 8, 4th Floor, South Abdollah Shokrabi Alley, Naz Alley, Heydari Street, Daneshgar, South Attari Moghaddam, Khaghani Street (Zargandeh), Shariati Street, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8490 1000
Email
hamedqurani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Ghorani
Position
متخصص رادیولوژی
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
No. 8, 4th Floor, South Abdollah Shokrabi Alley, Naz Alley, Heydari Street, Daneshgar, South Attari Moghaddam, Khaghani Street (Zargandeh), Shariati Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8490 1000
Email
hamedqurani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Koyar Hiwa Raouf
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Block A9/ Pak city / shakraka Qt.
City
sulaymanyiah
Province
sulaymanyiah
Postal code
46008
Phone
+964 775 719 6240
Fax
Email
kr.hiwa@gmail.com
Web page address

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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The shared dataset will include de-identified participant data, demographic and clinical characteristics, imaging findings, procedural details of transarterial embolization, and clinical outcomes including pain severity (VAS), shoulder function (Constant–Murley Score), and shoulder range of motion measured at baseline and at 1, 3, and 6 months after the intervention. No personally identifiable information will be shared.
When the data will become available and for how long
De-identified data will be available upon reasonable request after publication of the study results for a period of five years.
To whom data/document is available
Qualified researchers, research institutions, and scientific journals may access the de-identified dataset upon reasonable request and approval by the principal investigator.
Under which criteria data/document could be used
The de-identified data may be used for scientific research, educational purposes, systematic reviews, and meta-analyses following approval by the principal investigator. All data must be used in accordance with research ethics and participant confidentiality requirements.
From where data/document is obtainable
Requests should be directed to the Principal Investigator (Dr. Hamed Ghorani) through Imam Khomeini Hospital Complex.
What processes are involved for a request to access data/document
Applicants must submit a written request describing the intended use of the data. The request will be reviewed by the principal investigator for scientific and ethical appropriateness. Upon approval, the de-identified dataset will be shared.
Comments
Loading...