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Local Anesthetic
Corticosteroid Injection + Physiotherapy for Shoulder Pain
Phase 4
Waitlist Available
Led By Claire Bourgeois, BSc MD
Research Sponsored by Claire Bourgeois
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
There must also be a capsular pattern of reduced ROM of the shoulder, defined by a loss of 10 degrees or more of either external rotation, abduction or internal rotation ROM compared to the non painful shoulder
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week pre-injection, day of injection, 3-4 weeks post-injection, 3 months post-injection
Awards & highlights
Study Summary
This trial tests if a corticosteroid shot and gentle stretching can help reduce shoulder pain and restore movement.
Who is the study for?
This trial is for adults over 18 with post-stroke shoulder pain lasting at least 2 weeks, not relieved by physiotherapy. They must have a capsular pattern of reduced shoulder motion and be in an inpatient rehab program. Those with memory issues can join with assistance.Check my eligibility
What is being tested?
The study compares the effectiveness of two treatments: one combines physiotherapy with a glenohumeral injection (steroid and local anesthetic), while the other uses only physiotherapy to treat subacute hemiparetic shoulder pain.See study design
What are the potential side effects?
Possible side effects include discomfort or infection at the injection site, allergic reactions to medication, increased blood sugar levels due to cortisone, and potential weakening or rupture of tendons.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My shoulder moves less by 10 degrees or more in certain directions compared to my other shoulder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 week pre-injection, day of injection, 3-4 weeks post-injection, 3 months post-injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week pre-injection, day of injection, 3-4 weeks post-injection, 3 months post-injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain at night or at rest (whichever scores highest), measured on a visual analog scale from 0 to 10
Pain during activities of daily living (ADLs), measured on a visual analog scale from 0 to 10
Secondary outcome measures
Level of functioning, measured by the self-care section of the Functional Independence Measure.
Passive range of motion of shoulder (ROM) including flexion, abduction, internal and external rotation in degrees, measured with a goniometer
Quality of life, measured by the Medical Outcomes Study Short Form 12 applied to their shoulder pain
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Physiotherapy with mild arthrographic distensionExperimental Treatment1 Intervention
Physiotherapy continues after the participant receives a mild arthrographic distension with corticosteroid of the shoulder.
(This is a self-controlled study. The participants' clinical evolution with physiotherapy alone will be compared to their evolution after physiotherapy coupled with the injection.)
Group II: Physiotherapy aloneActive Control1 Intervention
Physiotherapy alone after diagnosis of hemiplegic shoulder pain with a capsular pattern. The physiotherapy will focus on stretching and range of motion of the shoulder.
(This is a self-controlled study. The participants' clinical evolution with physiotherapy alone will be compared to their evolution after physiotherapy coupled with the injection.)
Find a Location
Who is running the clinical trial?
Claire BourgeoisLead Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealOTHER
14 Previous Clinical Trials
2,072 Total Patients Enrolled
Fédération des médecins résidents du QuébecUNKNOWN
1 Previous Clinical Trials
220 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You will not be excluded if you have had more than one stroke.I am willing to join the study but do not want a corticosteroid injection.My shoulder pain began after my latest stroke.I have had pain for over 2 weeks that physiotherapy hasn't fixed.My shoulder pain is severe, affecting my sleep, daily activities, and rehabilitation.I am non-verbal or have cognitive difficulties but can participate with help.I am capable of understanding and giving consent to participate in the study.My pain has lasted for less than 6 months.My shoulder moves less by 10 degrees or more in certain directions compared to my other shoulder.I am over 18 and can communicate my health decisions.If you have difficulty remembering things on a memory test, the research team will make sure to double-check information with your doctors, medical records, or family members.I am 18 years old or older.Participants must be in a specific rehabilitation program at a certain hospital in Montreal.
Research Study Groups:
This trial has the following groups:- Group 1: Physiotherapy alone
- Group 2: Physiotherapy with mild arthrographic distension
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What adverse effects can individuals experience from mild arthrographic distension Physiotherapy?
"As this is a Phase 4 trial, suggesting that Physiotherapy with mild arthrographic distension has already been approved and thus can be rated as 3 on the safety scale."
Answered by AI
What outcomes is this trial attempting to realize?
"This clinical trial will be assessed over a designated timeline, including Baseline, 1 week pre-injection, day of injection and 3-4 weeks post-injection. The primary outcome evaluated is the Pain at night or rest (whichever scores highest) on a visual analog scale from 0 to 10. Secondary outcomes include Level of functioning as measured by Functional Independence Measure's self care section; Quality of Life as determined by Medical Outcomes Study Short Form 12 applied to shoulder pain; Side effects such as nausea, dizziness and metrorrhagia monitored through auto-reported symptoms plus an analysis of medical files; along with any medication"
Answered by AI
Are there still openings for this research endeavor?
"As per information hosted on clinicaltrials.gov, this trial is not currently accepting patients. Initially posted on May 1st 2023, the last update to the study was made 2 days later. Despite this research being dormant right now, there are 91 other studies presently seeking participants."
Answered by AI
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