Study on Pain Relief for Frozen Shoulder Using Methylprednisolone Acetate and Ropivacaine Hydrochloride in Adults

3 1 1

What is this study about?

This clinical trial is focused on treating a condition known as Frozen Shoulder, also referred to as Adhesive Capsulitis. This condition is characterized by pain and stiffness in the shoulder, which can limit movement. The study will explore the effectiveness of two treatments: an injection of a medication called Depo-Medrol, which contains methylprednisolone acetate, and a procedure known as a Suprascapular Nerve Block (SSNB). The trial will compare the effects of these treatments on pain relief and shoulder function.

The purpose of the study is to determine if there is a difference in pain relief and shoulder function when patients receive a combination of a Gleno-Humeral Intra-Articular Corticosteroid Injection (GH IACI) with a SSNB compared to a GH IACI with a sham (inactive) SSNB. Additionally, the study aims to identify which patients benefit most from these treatments. Participants will receive either the active treatment or a placebo, and their progress will be monitored over a period of time to assess changes in shoulder-related disability.

Throughout the study, participants will undergo various assessments, including clinical examinations and possibly MRI scans, to evaluate the condition of their shoulder. The study will help determine the best diagnostic criteria for early-stage Frozen Shoulder and guide clinical practice in treating this condition. The results will be used to improve treatment strategies and resource allocation for patients with Frozen Shoulder.

1 joining the study

Upon joining the study, participation begins with the administration of a Gleno-Humeral Intra-Articular Corticosteroid Injection (GH IACI) and a Suprascapular Nerve Block (SSNB) or a sham SSNB.

The purpose of these injections is to assess their effectiveness in reducing pain and improving shoulder function in individuals with a frozen shoulder.

2 medication administration

The medications used include Depo-Medrol 40 mg/1 ml Suspension Injectable and Ropivacaine Fresenius Kabi 2 mg/ml solution for injection.

These are administered through infiltration, which involves injecting the medication directly into the affected area.

3 follow-up assessments

Follow-up assessments occur at 4 weeks, 3 months, 6 months, and 12 months after the initial intervention.

These assessments include evaluating shoulder pain and disability using the Shoulder Pain and Disability Index (SPADI), and other measures such as the Numeric Pain Rating Scale (NPRS) and the Constant-Murley Score (CMS).

4 primary endpoint evaluation

The primary endpoint is the change in shoulder-related disability 3 months after the intervention, compared to a control group.

This is assessed through a validated questionnaire, the SPADI.

5 secondary endpoint evaluation

Secondary endpoints include pain levels, shoulder stiffness, and health-related quality of life, evaluated at various time points up to 12 months.

Additional tests such as the Coracoid Pain Test (CPT) and the Distension Test in Passive External Rotation (DTPER) are conducted to further assess shoulder function.

6 intermediary analysis

An intermediary statistical analysis is performed at 6 months.

If all outcomes show non-superiority at this point, the study will not be extended to the 12-month time point.

7 completion of study

The study is estimated to end by December 31, 2026.

The results will help guide clinical practice in treating frozen shoulder and improve resource allocation.

Who Can Join the Study?

You must provide written informed consent to participate in the study. This means you agree to join the study after understanding what it involves.
You must have a condition called Frozen Shoulder. This is when your shoulder is painful and you can’t move it well, and this has been going on for more than a month. X-rays of your shoulder should not show any unusual findings.
You need to speak either Dutch or French.
You must be 18 years or older.
If you are a control subject for the diagnostic accuracy part of the study, you should have shoulder pain but not meet the criteria for Frozen Shoulder.
If you are a control subject for the diagnostic accuracy part of the study, the other shoulder (not the one with Frozen Shoulder) will be considered.

Who Cannot Join the Study?

Patients who have had a shoulder injury or surgery in the past 6 months.
Individuals with severe shoulder arthritis, which is a condition where the joints in the shoulder are worn out.
People with a history of shoulder dislocation, meaning the shoulder joint has come out of place before.
Patients who have received a steroid injection in the shoulder in the last 3 months.
Individuals with a known allergy to steroids or local anesthetics, which are medicines used to numb an area.
People with a current infection in the shoulder area.
Patients with a history of severe heart, lung, or kidney disease.
Individuals who are pregnant or breastfeeding.
People who are unable to give informed consent, meaning they cannot understand and agree to the study details.
Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Vrije Universiteit Brussel	Jette	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Corticosteroid Injection is a treatment used in this study to help reduce inflammation and pain in the shoulder. It is injected directly into the shoulder joint, known as the Gleno-Humeral joint, to provide relief from the symptoms of Frozen Shoulder. This therapy aims to improve shoulder movement and decrease discomfort.

Suprascapular Nerve Block is another treatment being tested in this study. It involves injecting medication near the suprascapular nerve, which is responsible for transmitting pain signals from the shoulder. By blocking these signals, the nerve block can help reduce pain and improve shoulder function in patients with Frozen Shoulder.

Investigated diseases:

Periarthritis

Frozen Shoulder – Frozen Shoulder, also known as Adhesive Capsulitis, is a condition characterized by stiffness and pain in the shoulder joint. It typically develops gradually and worsens over time, often going through three stages: freezing, frozen, and thawing. During the freezing stage, pain increases and shoulder movement becomes limited. In the frozen stage, pain may decrease, but the shoulder remains stiff. The thawing stage involves a gradual return of movement. The exact cause is not always clear, but it can occur after an injury or surgery.

Trial ID:

2024-513057-78-00

NCT ID:

NCT06229964

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider