Tendinopathy of Rotator Cuff
Conditions
Brief summary
Shoulder tendinopathy is a common condition that causes shoulder pain and limits daily activities. It often results from damage or overuse of the rotator cuff tendons. Treatment typically includes rest, physical therapy, anti-inflammatory medications, and sometimes injections. This clinical trial aims to compare the effectiveness of two types of injections for treating simple shoulder tendinopathy: Corticosteroid injections, which reduce inflammation and provide quick pain relief, but may have only short-term effects. Platelet-Rich Plasma (PRP) injections, a newer treatment made from the patient's own blood, which may promote long-term healing. The study is being conducted at the Rheumatology Department of Charles Nicolle Hospital in Tunis, Tunisia. A total of 60 adult patients with shoulder tendinopathy will be randomly assigned to receive either a corticosteroid injection or a PRP injection. Participants will be evaluated before the injection (baseline), after one week, and after three months. The researchers will assess pain levels using a visual analog scale (VAS), and shoulder function using validated questionnaires (DASH and SPADI scores). The goal is to determine which treatment provides better pain relief and functional improvement over time.
Interventions
PROCEDURECorticosteroid Injection
This intervention consists of a single injection of corticosteroids administered directly into the affected tendon of the shoulder. Corticosteroids are anti-inflammatory drugs used to rapidly reduce inflammation and pain associated with tendinopathy. The injection is performed under aseptic conditions by a trained physician. The aim is to provide quick pain relief and improve shoulder function, although effects may be temporary.
PROCEDUREplatelet-rich plasma injection
This intervention involves a single injection of Platelet-Rich Plasma (PRP), which is prepared from the patient's own blood through a process of centrifugation to concentrate platelets. PRP contains growth factors that may promote tissue healing and regeneration. The injection is administered under aseptic conditions into the affected shoulder tendon by a trained physician. The goal is to enhance long-term recovery of tendon function and reduce pain.
Sponsors
Hopital Charles Nicolle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years and older * Diagnosed with simple tendinopathy of the shoulder confirmed by clinical examination and imaging * Experiencing shoulder pain for at least 4 weeks * Able to provide informed consent
Exclusion criteria
* Previous shoulder surgery on the affected side * Presence of rotator cuff tear or severe shoulder pathology * Systemic inflammatory diseases (e.g., rheumatoid arthritis) * Recent corticosteroid injection in the affected shoulder (within last 3 months) * Contraindications to corticosteroids or PRP treatment * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity measured by Visual Analog Scale (VAS) | baseline, 1 week, 3 months | The Visual Analog Scale (VAS) ranges from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain. Higher scores represent worse pain outcomes. |
| Change in shoulder function measured by the Disabilities of the Arm, Shoulder and Hand (DASH) score | baseline, 1 week and 3 months | The DASH score ranges from 0 to 100. Higher scores indicate greater disability (worse function). |
| Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI) | baseline, 1 week, 3 months | The SPADI score ranges from 0 to 100. Higher scores indicate greater pain and disability. |
Countries
Tunisia
Contacts
Primary ContactSelma Bouden, Assistant doctor
Outcome results
None listed