Corticosteroid Versus PRP Injections for Shoulder Tendinopathy

NCT07094178 | Recruiting

• 1 other identifier: PRP-CS-2025-CN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  baseline, 1 week, 3 months

Study Arms (2)

Corticosteroid Injection

EXPERIMENTAL

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

Platelet-Rich Plasma (PRP) Injection

EXPERIMENTAL

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

Interventions

Corticosteroid Injection 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.

Corticosteroid Injection

platelet-rich plasma injection 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.

Platelet-Rich Plasma (PRP) Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Charles Nicolle: lead

Study Sites (1)

Charles Nicolle Hospital

Tunis, Tunisia

RECRUITING

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Selma Bouden, Assistant doctor

CONTACT

0021624685748; selma.bouden@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant doctor

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 30, 2025
• Study Start: June 30, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)