Corticosteroid Versus PRP Injections for Shoulder Tendinopathy

NCT ID: NCT07094178

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-11-01

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.

Conditions

Tendinopathy of Rotator Cuff

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Corticosteroid Injection

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.

Group Type: EXPERIMENTAL

Corticosteroid Injection

Intervention Type: PROCEDURE

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.

Platelet-Rich Plasma (PRP) 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.

Group Type: EXPERIMENTAL

platelet-rich plasma injection

Intervention Type: PROCEDURE

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.

Interventions

Corticosteroid 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.

Intervention Type: PROCEDURE

platelet-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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Charles Nicolle

OTHER

Sponsor Role: lead

Responsible Party

Selma Bouden

assistant doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charles Nicolle Hospital

Tunis, , Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

Selma Bouden, Assistant doctor

Role: CONTACT

selma.bouden@gmail.com

0021624685748

Facility Contacts

Selma Bouden, Assistant doctor

Role: primary

selma.bouden@gmail.com

0021624685748

Other Identifiers

PRP-CS-2025-CN

Identifier Type: -

Identifier Source: org_study_id