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This clinical trial focuses on treating chronic omalgia, which is persistent shoulder pain associated with rotator cuff tendinopathy - a condition affecting the tendons in the shoulder. The study compares two different treatment approaches to help patients with shoulder pain that hasn't responded to standard pain medications.
The study will test two treatments: platelet-rich plasma (PRP) injections, which use concentrated platelets from the patient's own blood, compared to injections containing betamethasone (a steroid) and ropivacaine (a pain medication). Both groups of patients will also follow a personalized exercise program. The main goal is to determine if PRP injections combined with exercise are more effective at reducing shoulder pain and improving function than steroid injections with exercise.
During the study, patients will receive two injections of either PRP or the combination of betamethasone and ropivacaine. The treatment period lasts up to 15 days, and patients will be monitored for changes in their shoulder function and pain levels over six months. The effectiveness of the treatment will be measured using a special scoring system that evaluates shoulder function and pain.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
5 criteria
15 criteria
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A therapeutic preparation derived from the patient's own blood that contains a high concentration of platelets and growth factors, administered through local injection into the affected shoulder area. This biological treatment is currently widely studied in regenerative medicine and has shown promising results in treating various musculoskeletal conditions, particularly in tendinopathies and soft tissue injuries. PRP works by releasing growth factors that stimulate tissue healing and regeneration at the molecular level, promoting the repair of damaged tendons and reducing inflammation. It belongs to the class of autologous biological therapies and is often used in orthopedic medicine as an alternative to conventional treatments.
A synthetic corticosteroid medication administered through injection, commonly used in combination with local anesthetics for treating inflammatory conditions and joint pain. This medication is well-established in medical practice and has strong evidence supporting its use in managing various musculoskeletal disorders, particularly those involving inflammation and pain. It works by suppressing the immune response and reducing inflammation at the molecular level, thereby alleviating pain and improving joint function. It belongs to the glucocorticoid class of medications and is frequently used in orthopedic medicine for its potent anti-inflammatory properties.
A long-acting local anesthetic medication administered through injection, often used in combination with corticosteroids for pain management in musculoskeletal conditions. This medication has been extensively studied and is widely used in clinical practice for its reliable pain-blocking properties and favorable safety profile. It works by blocking sodium channels in nerve cells, preventing the transmission of pain signals to the brain, and belongs to the amino amide class of local anesthetics. The medication provides extended pain relief while maintaining motor function, making it particularly suitable for orthopedic procedures and pain management.
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Spain
The Netherlands
Czechiasourced from the EU Clinical Trials Register and site verification
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