Image

Comparison of the Effect of Combined Glenohumeral Joint and Subdeltoid Bursa Injection With Platelet-rich Plasma (PRP), Corticosteroid, and Normal Saline in Addition to Physical Therapy for Treatment of Frozen Shoulder

Recruiting
20 - 80 years of age
Both
Phase N/A

Powered by AI

Overview

Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection.

Description

This is a prospective assessor-blinded randomized controlled trial. We plan to enroll 90 participants with frozen shoulder from the outpatient clinic of the Department of Physical Medicine and Rehabilitation in our hospital. The study protocol and consent form have been approved by our ethics committee. After detailed explanation about the content of this study, participant is asked to sign an informed consent. The patients will be randomly divided into three groups: 1). PRP injection (PRP group); 2). Corticosteroid injection (CS group); 3). Normal saline injection (NS group). Randomization will be assigned according to a random number from a computer program by a statistician. The patients and the evaluator are unknown which group the patients are allocated, but the physician who performs joint injection knows which group the patients are assigned.

Eligibility

Inclusion Criteria:

  1. . age between 20 to 80 years old;
  2. . shoulder pain for ≥ 1 months;
  3. . > 30% loss of passive range of motion (ROM) of the affected shoulder in external rotation and/or abduction, comparing with the sound side;
  4. . visual analog scale for pain on maximal passive external rotation or abduction > 4;
  5. an empty or soft end feel on passive external rotation, or abduction and/or presence of night pain or rest pain;
  6. showing willing to attend regular physical therapy programs for 8 weeks.

Exclusion Criteria:

  1. . severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
  2. . uncontrolled DM;
  3. . rotator cuff tear or calcification of the affected shoulder;
  4. . fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;
  5. . a hard end feel on passive external rotation or abduction of the affected shoulder;
  6. . a history of drug allergy to local anesthetics or corticosteroids;
  7. . receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder during the preceding three months.

Study details

Frozen Shoulder, Adhesive Capsulitis, Shoulder, Platelet-rich Plasma, Corticosteroid

NCT05230667

Shin Kong Wu Ho-Su Memorial Hospital

1 May 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.