PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy

Phase 3

Recruiting

• Conditions: Lateral Epicondylitis; Rotator Cuff Syndrome
• Interventions: Combination Product: lyophilized platelet (30ng) and triamcinolone acetonide 10mg; Other: lyophilized platelet (30ng); Drug: triamcinolone acetonide 10mg

• Registration Number: NCT05648032
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-10-06
• Study First Submitted: 2022-11-20
• Study First Submitted QC: 2022-12-04
• Last Update Submitted: 2022-12-12
• Study First Posted: 2022-12-13
• Last Update Posted: 2022-12-14
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLT (lyophilized platelet) with steroid	lyophilized platelet (30ng) and triamcinolone acetonide 10mg	PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once
PLT (lyophilized platelet)	lyophilized platelet (30ng)	PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL normal saline, once
Steroid	triamcinolone acetonide 10mg	1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once

Primary Outcome Measures

Name	Time	Method
Lateral elbow pain and shoulder pain (worst in the last one week)	24 weeks post-injection	Visual analogue scale (0-10, the high the worse)

Secondary Outcome Measures

Name	Time	Method
Lateral elbow pain and shoulder pain (worst in the last one week)	Baseline, 2, 4, 6, and 12 weeks post-injection	Visual analogue scale (0-10, the high the worse)
Functional	Baseline, 2, 4, 6, 12, and 24 weeks post-injection	Disabilities of the Arm, Shoulder, and Hand (Score 0-100, the high the worse)
Grasping power	Baseline, 2, 4, 6, 12, and 24 weeks post-injection	Grasping power
Ultrasound	Baseline, 12 and 24 weeks post-injection	Calcification size (mm)

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan