Frozen ShoulderPhase 1/2AESNCT03676829
Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis
A Phase 1/2 study testing Arterial Embolization of the Shoulder in people with Frozen Shoulder and Adhesive Capsulitis, run by Vascular Institute of Virginia at 1 site in United States.
Trial summary
This study is to test a new treatment method, arterial embolization of the shoulder (AES), to reduce the severity of pain and improve range of motion (ROM), and to see if it can be performed safely. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Frozen Shoulder, Adhesive Capsulitis
- What is being tested?
- Arterial Embolization of the Shoulder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2018to Dec 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate to severe shoulder pain (VAS greater than 40mm), and
- diagnosis of adhesive capsulitis, and
- age > 21, and
- pain refractory to at least 30 days of conservative therapy (pain medications, physical therapy, etc.)
Who cannot join
- current local infection, or
- life expectancy less than 6 months, or
- known advanced atherosclerosis, or
- rheumatoid or infectious arthritis, or
- prior shoulder replacement surgery, or
- uncorrectable coagulopathy as defined by INR > 2.5 or platelets < 30,000, or
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- iodine allergy resulting in anaphylaxis, or
- renal dysfunction as defined by GRF of < 45, or
- contraindication for magnetic resonance imaging, or
- known complete full thickness tear of rotator cuff, or
- currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vascular Institute of Virginia
Woodbridge, Virginia, 22193
Julie Orlando, CCRC, 703-763-5224, jorlando@teamviv.com
Molly Godin, RN, 703-763-5224, mgodin@teamviv.com
About this study
This study is to test a new treatment method, arterial embolization of the shoulder (AES), to reduce the severity of pain and improve range of motion (ROM), and to see if it can be performed safely.
Read the detailed description
Purpose: The primary aims of this study are to determine if arterial embolization of the shoulder will reduce the severity of pain as well improve Range of Motion (ROM) caused by adhesive capsulitis and if it can be performed safely. The secondary aim is to determine if AES can result in the decreased necessity for ongoing conservative therapies, such as medication therapy and joint injections.
Participants: Twenty patients with adhesive capsulitis, resulting in shoulder pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months.
Procedures (methods): This will be an open label 24-month pilot study with a small population undergoing AES to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for arterial embolization of the shoulder, and follow-up visits at 24 hours, 1, 3 \& 6 months. An MRI will be performed at the 1-month visit to detect a change in capsular vascularity and to exclude complication.
- Conditions
- Frozen Shoulder, Adhesive Capsulitis
- Being tested
- Arterial Embolization of the Shoulder
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Embolization of the ShoulderDevice
Arterial Embolization of the Shoulder (AES) is a new procedure that is being used to reduce pain and improve range of motion (ROM) caused by adhesive capsulitis. Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the shoulder, resulting in improvement of pain, stiffness and from adhesive capsulitis.
| Study group | Role | What they receive |
|---|---|---|
| Arterial Embolization of the Shoulder (AES) | Experimental | Patients in this study will receive the arterial embolization of the shoulder (AES) procedure. The primary aims will be to determine if arterial embolization of the shoulder (AES) will reduce pain and improve range of motion (ROM) caused by adhesive capsulitis. Receives: Device: Arterial Embolization of the Shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient's follow-up visits and used to measure the change from baseline (prior to the AES procedure). The investigators will use this to measure if the patient's pain level decreases.
Measured: 6 months
Patient Function
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding range of motion, stiffness, and pain and how it affects the ability to function.
Measured: 6 months
Secondary outcomes (2)
Reduction in Medication
Reduction in the number or strength of previously initiated medical therapy (e.g. NSAIDs).
Measured: 6 months
Improvement of Range of Motion
Patients' range of motion will be assessed prior to undergoing embolization and at 1,3, and 6 month follow ups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start13 Sep 2018
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascular Institute of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Medical Corporation
- Responsible party
- Principal investigator, Sandeep Bagla, Vascular Institute of Virginia
- Investigators
- Sandeep Bagla, MD, Principal investigator, Vascular Institute of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676829
- Sponsor's protocol ID
- G180115
- Other IDs
- 20181853
- Acronym
- AES
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT03676829
- Acronym / sponsor ID
- AES / G180115
- Conditions
- Frozen Shoulder, Adhesive Capsulitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vascular Institute of VirginiaUniversity, hospital or other
- Collaborators
- Terumo Medical Corporation
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to test a new treatment method, arterial embolization of the shoulder (AES), to reduce the severity of pain and improve range of motion (ROM), and to see if it can be performed safely.
Detailed description
Purpose: The primary aims of this study are to determine if arterial embolization of the shoulder will reduce the severity of pain as well improve Range of Motion (ROM) caused by adhesive capsulitis and if it can be performed safely. The secondary aim is to determine if AES can result in the decreased necessity for ongoing conservative therapies, such as medication therapy and joint injections.
Participants: Twenty patients with adhesive capsulitis, resulting in shoulder pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months.
Procedures (methods): This will be an open label 24-month pilot study with a small population undergoing AES to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for arterial embolization of the shoulder, and follow-up visits at 24 hours, 1, 3 \& 6 months. An MRI will be performed at the 1-month visit to detect a change in capsular vascularity and to exclude complication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arterial Embolization of the Shoulder (AES) | Experimental | Device: Arterial Embolization of the ShoulderPatients in this study will receive the arterial embolization of the shoulder (AES) procedure. The primary aims will be to determine if arterial embolization of the shoulder (AES) will reduce pain and improve range of motion (ROM) caused by adhesive capsulitis. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- moderate to severe shoulder pain (VAS greater than 40mm), and
- diagnosis of adhesive capsulitis, and
- age > 21, and
- pain refractory to at least 30 days of conservative therapy (pain medications, physical therapy, etc.)
Key exclusion criteria (11 listed)
- current local infection, or
- life expectancy less than 6 months, or
- known advanced atherosclerosis, or
- rheumatoid or infectious arthritis, or
- prior shoulder replacement surgery, or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial Embolization of the ShoulderArterial Embolization of the Shoulder (AES) is a new procedure that is being used to reduce pain and improve range of motion (ROM) caused by adhesive capsulitis. Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the shoulder, resulting in improvement of pain, stiffness and from adhesive capsulitis. | Device | Arterial Embolization of the Shoulder (AES) |
Primary outcome
Patient Pain
Time frame: 6 months
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient's follow-up visits and used to measure the change from baseline (prior to the AES procedure). The investigators will use this to measure if the patient's pain level decreases.
Patient Function
Time frame: 6 months
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding range of motion, stiffness, and pain and how it affects the ability to function.
2 secondary outcomes
Reduction in Medication
Time frame: 6 months
Improvement of Range of Motion
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Bagla, MD principal investigator
Vascular Institute of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Arterial Embolization of the Shoulder in people with Frozen Shoulder and Adhesive Capsulitis, run by Vascular Institute of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Orlando, CCRC (703-763-5224, jorlando@teamviv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Pain (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.