An interventional study of Corticosteroid Injection and platelet-rich plasma injection in Tendinopathy of Rotator Cuff, sponsored by Hopital Charles Nicolle. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Hopital Charles Nicolle · Not applicable, Interventional, and Treatment
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.
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
This study's planned enrollment of 60 is above the median of 48 across 332 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →Hopital Charles Nicolle is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive a single infiltration of corticosteroids into the affected shoulder tendon. Corticosteroids are anti-inflammatory medications commonly used to reduce pain and inflammation in tendinopathies. The injection aims to provide rapid pain relief and improve shoulder function. Patients will be monitored for pain reduction and functional improvement at one week and three months after the injection.
Procedure: Corticosteroid Injection
Participants in this arm will receive a single infiltration of Platelet-Rich Plasma (PRP) into the affected shoulder tendon. PRP is prepared from the patient's own blood and contains growth factors that may promote tissue healing and regeneration. This treatment aims to provide longer-term pain relief and functional improvement. Patients will be evaluated for pain and shoulder function at one week and three months following the injection.
Procedure: platelet-rich plasma 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.
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.
Change in pain intensity measured by Visual Analog Scale (VAS)
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.
Time frame: baseline, 1 week, 3 months
Change in shoulder function measured by the Disabilities of the Arm, Shoulder and Hand (DASH) score
The DASH score ranges from 0 to 100. Higher scores indicate greater disability (worse function).
Time frame: baseline, 1 week and 3 months
Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI)
The SPADI score ranges from 0 to 100. Higher scores indicate greater pain and disability.
Time frame: baseline, 1 week, 3 months
Plan to share: Yes — De-identified individual participant data (including clinical and demographic data) will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary results. Requests can be submitted to the principal investigator, who will review and approve data sharing agreements to ensure participant privacy and compliance with ethical regulations.
Started Jun 2025 (actual). Primary completion is estimated for Oct 2025, 3 months after the start.
Of 174 non-industry interventional studies with no phase under Tendinopathy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 3 months is below that.
Counting every sponsor, half of 183 studies reached it within 20 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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Hopital Charles Nicolle