PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy

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

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

Study Overview

• Status: Recruiting
• Conditions: Lateral Epicondylitis; Rotator Cuff Syndrome
• Intervention / Treatment: Combination product: lyophilized platelet (30ng) and triamcinolone acetonide 10mg; Other: lyophilized platelet (30ng); Drug: triamcinolone acetonide 10mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chueh-Hung Wu, MD, PhD; Phone Number: 266473 886-2-23123456; Email: nojred@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Wan-Ju Chien, M.S.; Phone Number: 266473 886-2-23123456; Email: wanzu21@gmail.com
    • Principal Investigator: Chueh-Hung Wu, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLT (lyophilized platelet) with steroid; PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once	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 Names: PLT and steroid
Experimental: PLT (lyophilized platelet); PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL normal saline, once	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); Other Names: Blood product
Active Comparator: Steroid; 1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once	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); Other Names: steroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Grasping power	Grasping power	Baseline, 2, 4, 6, 12, and 24 weeks post-injection
Ultrasound	Tendon thickness (mm)	Baseline, 12 and 24 weeks post-injection
Ultrasound	Calcification size (mm)	Baseline, 12 and 24 weeks post-injection
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chueh-Hung Wu, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Anticipated): April 30, 2025
• Study Completion (Anticipated): April 30, 2025

Study Registration Dates

• First Submitted: November 20, 2022
• First Submitted That Met QC Criteria: December 4, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Arm Injuries; Elbow Tendinopathy; Tendinopathy; Tennis Elbow; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 201903076DIPC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No