PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy

Lateral Epicondylitis Clinical Trial

Official title:

The Clinical Application of PLT Combined With Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648032
• Other study ID #: 201903076DIPC
• Status: Recruiting
• Phase: Phase 3
• Start date: October 6, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2022
• Source: National Taiwan University Hospital
• Contact: Chueh-Hung Wu, MD, PhD
• Phone: 886-2-23123456
• Email: nojred[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PLT vs. steroid vs. PLT + steroid, which treatment is most effective in lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis.

Description:

Lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis are common tendinopathies of the upper limb and both have negative impacts on the patients' quality of life. The former affects function of wrist extension due to degeneration of common extensor tendons; the latter causes severe pain and limitation of shoulder range of motion due to calcific deposits within the supraspinatus tendon. Current common injection therapies are ultrasound-guided injection of steroid or platelet-rich plasma (PRP). Previous studies have shown that steroid injection provides early but short-term pain reduction, while PRP injection causes post-injection pain by inducing inflammation but provides long-term pain relief and functional improvement. It may provide early pain reduction with long-term tissue regeneration if combining steroid and PRP. A recent study on tennis elbow showed that inclusion of steroid in the autologous whole blood and 20% dextrose injection can reduce pain during early treatment, without interfering with the therapeutic effects. Furthermore, disadvantages of current PRP include difficulty in quantifying platelet numbers and growth factor activity, and in long-term preservation. In this study lyophilized platelet (PLT) can solve these problems, which can be dissolved in saline before injection. This 3-arm randomized controlled trial will divide subjects into the PLT group (group A), steroid group (group B) or PLT+steroid group (group C). Therapeutic effects will be evaluated by pain visual analogue scale (VAS), grip dynamometer, and disabilities of the arm, shoulder, and hand (DASH) questionnaires during follow-ups at 2nd, 4th, 6th, 12th and 24th week after treatment, and ultrasound at 12th and 24th week . The hypothesis is that PLT+steroid injection will have earlier pain reduction than PLT injection and longer effects of pain reduction and functional improvement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Lateral epicondylitis

Inclusion Criteria:

• Tenderness at lateral epicondyle more than 3 months
• Ultrasound-confirmed lateral epicondylopathy
• Pain VAS = 3/10 during wrist resistive extension
• No treatment response to NSAID and physiotherapy

Exclusion Criteria:

• Pregnancy or lactation
• Carpal tunnel syndrome (the same arm) in one year
• Cervical radiculopathy
• Taking NSAID in one week
• Receiving PRP or steroid injection in one month
• History of bacteremia, cellulitis or skin ulcer in three months
• Rheumatoid arthritis
• Malignancy
• Poorly controlled diabetets mellitus (DM), liver and kidner diseases
• Severe anemia (Hb<5)
• Thrombocytopenia
• History of tennis elbow surgery
• History of elbow trauma Supraspinatus calcific tendinis

Inclusion Criteria:

• Hawkins-Kennedy test or empty can test, one of which is positive
• Ultrasound-confirmed (calcification > 2mm)
• Pain VAS = 3/10 over right deltoid area more than 3 months
• No treatment response to NSAID and physiotherapy

Exclusion Criteria:

• Pregnancy or lactation
• Carpal tunnel syndrome (the same arm) in one year
• Cervical radiculopathy
• Taking NSAID in one week
• Receiving PRP or steroid injection in one month
• History of bacteremia, cellulitis or skin ulcer in three months
• Rheumatoid arthritis
• Malignancy
• Poorly controlled DM, liver and kidner diseases
• Severe anemia (Hb<5)
• Thrombocytopenia
• History of shoulder surgery
• History of shoulder trauma

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Rotator Cuff Syndrome
• Tendinopathy
• Tennis Elbow

Intervention

Combination Product:
• lyophilized platelet (30ng) and triamcinolone acetonide 10mg
Ultrasound-guided injection of lyophilized platelet (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide into the hypoechoic area of common extensor tendon (in lateral epicondylopathy) or around calcific spots (in supraspinatus calcific tendinitis)

Other:
• lyophilized platelet (30ng)
Ultrasound-guided injection of PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL normal saline into the hypoechoic area of common extensor tendon (in lateral epicondylopathy) or around calcific spots (in supraspinatus calcific tendinitis)

Drug:
• triamcinolone acetonide 10mg
Ultrasound-guided injection of 1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide into the hypoechoic area of common extensor tendon (in lateral epicondylopathy) or around calcific spots (in supraspinatus calcific tendinitis)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lateral elbow pain and shoulder pain (worst in the last one week)	Visual analogue scale (0-10, the high the worse)	24 weeks post-injection
Secondary	Lateral elbow pain and shoulder pain (worst in the last one week)	Visual analogue scale (0-10, the high the worse)	Baseline, 2, 4, 6, and 12 weeks post-injection
Secondary	Functional	Disabilities of the Arm, Shoulder, and Hand (Score 0-100, the high the worse)	Baseline, 2, 4, 6, 12, and 24 weeks post-injection
Secondary	Grasping power	Grasping power	Baseline, 2, 4, 6, 12, and 24 weeks post-injection
Secondary	Ultrasound	Tendon thickness (mm)	Baseline, 12 and 24 weeks post-injection
Secondary	Ultrasound	Calcification size (mm)	Baseline, 12 and 24 weeks post-injection