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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

Must not have

Patients with pain duration of more than 6 months will be excluded

Patients below the age of 18 years will be excluded

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

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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 below

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My shoulder moves less by 10 degrees or more in certain directions compared to my other shoulder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My pain has lasted for less than 6 months.

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I am 18 years old or older.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week pre-injection, day of injection, 3-4 weeks post-injection, 3 months post-injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.)

0 / 3Eligibility criteria met