Osteoarthritis of the Glenohumeral JointPhase 4NCT03232749

Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint

A Phase 4 study testing intraarticular corticosteroid injections (IACSI), corticosteroid injections and Ultrasound in people with Osteoarthritis of the Glenohumeral Joint, run by University of Florida at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will examine the effectiveness of a single cortisone injection in patients with shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors to help predict how a patient with shoulder osteoarthritis will respond to a cortisone injection utilizing ultrasound guidance. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Osteoarthritis of the Glenohumeral Joint
What is being tested?: intraarticular corticosteroid injections (IACSI), corticosteroid injections and Ultrasound
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 2 sitesUnited States
Study dates: 18 Apr 2018to 6 Jun 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will be recruited from the patient population seeking treatment at the Orthopaedics Sports Medicine Institute.
those who have failed previous treatment including over-the-counter analgesics and activity modification
have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder.

Who cannot join

Patients will be excluded from the study for any of the following reasons:
Post traumatic osteoarthritis
Inflammatory osteoarthritis
Imaging confirmed rotator cuff tear
Prior ipsilateral shoulder surgery
Memory loss or inability to complete study measures

Show all 9Show fewer

History of allergy to injection medications
Diabetic patients with patient-reported fasting blood glucose >200
Prior injection in the ipsilateral shoulder within three months

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UF and Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32611
UF Health Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32611

Other trials in United States

About this study

Read the detailed description

The purpose of this study is to assess the effectiveness of intraarticular corticosteroid injections (IACSI) for glenohumeral arthritis by 1) through patient-reported outcomes and 2) identifying clinical and radiographic predictors of IACSI success.

Conditions: Osteoarthritis of the Glenohumeral Joint
Being tested: intraarticular corticosteroid injections (IACSI), corticosteroid injections, Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intraarticular corticosteroid injections (IACSI)Procedure or surgery
ultrasound-guided IACSI will be administered
corticosteroid injectionsDrug
Also called Methylprednisolone, Depo-medrol
Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder
UltrasoundDevice
ultrasound-guided IACSI

Study groups in NCT03232749
Study group	Role	What they receive
symptomatic primary osteoarthritis of the shoulder	Other	Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder Receives: Procedure: intraarticular corticosteroid injections (IACSI); Drug: corticosteroid injections; Device: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

ASES Scores at Each Time Point
ASES (American Shoulder \& Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).
Measured: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months
Visual Analog Scale Scores at Each Time Point.
VAS (Visual Analog Scale) pain score improvement > 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain.
Measured: Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months
SST (Simple Shoulder Test) Scores at Each Time Point
SST (Simple Shoulder Test) score improvement > 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better)
Measured: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 20186 Jun 2019

First posted28 Jul 2017
Study start18 Apr 2018
Primary completion6 Jun 2019
Study completion6 Jun 2019

Why it stopped: The physician in charge is leaving the University of Florida

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis of the Glenohumeral JointStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03232749
Sponsor's protocol ID: IRB201700603-A
Other IDs: OCR18320
Status last verified: Jun 2021
First submitted: 26 Jun 2017
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruitingObservational study
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
Rotator Cuff Tears, Rheumatoid Arthritis Shoulder
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
Glenohumeral Osteoarthritis, Proximal Humerus Fracture
RecruitingObservational study
RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
Humeral Fracture, Proximal, Glenohumeral Osteoarthritis
Active, not recruiting
Performance and Safety of HyalganBio® Intra-Articular Injections as Add-On to Physical Exercise for Symptomatic Glenohumeral Osteoarthritis
Glenohumeral Osteoarthritis

All Osteoarthritis of the Glenohumeral Joint trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
ClinicalTrials.gov ID: NCT03232749
Acronym / sponsor ID: IRB201700603-A
Conditions: Osteoarthritis of the Glenohumeral Joint
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The physician in charge is leaving the University of Florida
Enrolment: 25 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: 18 Apr 2018 (actual)
Primary completion: 6 Jun 2019 (actual)
Study completion: 6 Jun 2019 (actual)
First posted: 28 Jul 2017 (actual)
Results: Posted 9 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
symptomatic primary osteoarthritis of the shoulder	Other	Procedure: intraarticular corticosteroid injections (IACSI), Drug: corticosteroid injections, Device: UltrasoundSubjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will be recruited from the patient population seeking treatment at the Orthopaedics Sports Medicine Institute.
those who have failed previous treatment including over-the-counter analgesics and activity modification
have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder.

Key exclusion criteria (9 listed)

Patients will be excluded from the study for any of the following reasons:
Post traumatic osteoarthritis
Inflammatory osteoarthritis
Imaging confirmed rotator cuff tear
Prior ipsilateral shoulder surgery

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
intraarticular corticosteroid injections (IACSI)ultrasound-guided IACSI will be administered	Procedure or surgery	symptomatic primary osteoarthritis of the shoulder
corticosteroid injectionsAlso: Methylprednisolone, Depo-medrolCorticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder	Drug	symptomatic primary osteoarthritis of the shoulder
Ultrasoundultrasound-guided IACSI	Device	symptomatic primary osteoarthritis of the shoulder

Primary outcome

ASES Scores at Each Time Point
Time frame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months
ASES (American Shoulder \& Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).
Visual Analog Scale Scores at Each Time Point.
Time frame: Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months
VAS (Visual Analog Scale) pain score improvement > 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain.
SST (Simple Shoulder Test) Scores at Each Time Point
Time frame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months
SST (Simple Shoulder Test) score improvement > 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better)

Results and safety

Results posted to the registry on 9 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symptomatic Primary Osteoarthritis of the Shoulder	25	21

Primary outcome: ASES Scores at Each Time Point

Time frame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Symptomatic Primary Osteoarthritis of the Shoulder n = 25
Baseline ASES score	48.52 (13.18)
2 Week ASES score	79.72 (23.32)
1 Month ASES scrore	73.86 (28.24)
2 Month ASES score	28.60 (28.57)
3 Month ASES score	71.78 (22.34)
6 Month ASES score	61.48 (25.78)

Population analysed: All participants did not return for all outcome measure time points

Primary outcome: Visual Analog Scale Scores at Each Time Point.

Time frame: Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Symptomatic Primary Osteoarthritis of the Shoulder n = 25
Baseline VAS score	4.54 (2.62)
Post-injection VAS score	1.86 (1.80)
2 Weeks VAS score	1.18 (1.59)
1 Month VAS score	2.05 (2.06)
2 Month VAS score	2.56 (2.97)
3 Month VAS score	2.50 (2.38)
6 Month VAS score	2.44 (3.05)

Population analysed: All participants did not return for all outcome measure time points

Primary outcome: SST (Simple Shoulder Test) Scores at Each Time Point

Time frame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Symptomatic Primary Osteoarthritis of the Shoulder n = 25
Baseline SST Score	5.29 (2.46)
2 Week SST Score	8.40 (2.36)
1 Month SST Score	7.32 (3.82)
2 Month SST Score	5.92 (3.43)
3 Month SST Score	6.73 (3.32)
6 Month SST Score	7.00 (2.73)

Population analysed: All participants did not return for all outcome measure time points

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symptomatic Primary Osteoarthritis of the Shoulder	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Osteoarthritis of the Glenohumeral Joint

Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruitingObservational study
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
Rotator Cuff Tears, Rheumatoid Arthritis Shoulder
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
Glenohumeral Osteoarthritis, Proximal Humerus Fracture
RecruitingObservational study
RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
Humeral Fracture, Proximal, Glenohumeral Osteoarthritis
Active, not recruiting
Performance and Safety of HyalganBio® Intra-Articular Injections as Add-On to Physical Exercise for Symptomatic Glenohumeral Osteoarthritis
Glenohumeral Osteoarthritis

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.

Bradley Schoch, M.D. principal investigator

Faculty

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ASES Scores at Each Time Point (time frame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03232749.

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 14 Jun 2021.