Study on Pain Relief for Frozen Shoulder Using Methylprednisolone Acetate and Ropivacaine Hydrochloride in Adults
This clinical trial focuses on treating frozen shoulder, a painful condition that causes stiffness and limited movement in the shoulder joint. The study aims to determine whether combining two treatments provides better pain relief and improved shoulder function than using only one treatment.
Main focus of the trial: The study compares the effectiveness of a corticosteroid injection into the shoulder joint combined with a suprascapular nerve block against a corticosteroid injection combined with an inactive (sham) nerve block. Participants will be monitored over 12 months to assess changes in pain levels, shoulder disability, and overall function. The researchers will evaluate participants at several time points: 4 weeks, 3 months, 6 months, and 12 months after treatment. The primary goal is to measure the change in shoulder-related disability at 3 months using a validated questionnaire called the Shoulder Pain and Disability Index.
Investigational treatments: The trial uses two main treatments. The first is a corticosteroid injection containing Depo-Medrol (methylprednisolone acetate), which is injected directly into the shoulder joint to reduce inflammation and pain. The second is a suprascapular nerve block using ropivacaine, which blocks pain signals from the shoulder by targeting the suprascapular nerve. Some participants will receive the active nerve block, while others will receive an inactive version to help researchers determine the true effectiveness of the combination treatment.
Who can participate: To join this study, you must be 18 years or older and have frozen shoulder that has lasted for more than one month, with shoulder pain and limited movement. X-rays of your shoulder should not show any unusual findings. You must be able to speak Dutch or French and provide written consent after understanding what the study involves. Some participants may be enrolled as control subjects if they have shoulder pain but do not meet the full criteria for frozen shoulder.
Who cannot participate: You cannot join this study if you have had shoulder injury or surgery within the past 6 months, or if you have severe shoulder arthritis. People with a history of shoulder dislocation or those who have received a steroid injection in the shoulder within the last 3 months are excluded. You also cannot participate if you have a known allergy to steroids or local anesthetics, a current shoulder infection, or severe heart, lung, or kidney disease. Pregnant or breastfeeding women, people unable to provide informed consent, and those already participating in another clinical trial are not eligible.
France
