PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy
NCT ID: NCT05648032
Last Updated: 2022-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2022-10-06
2025-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PLT (lyophilized platelet) with steroid
PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once
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)
PLT (lyophilized platelet)
PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL normal saline, once
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)
Steroid
1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once
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)
Interventions
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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)
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)
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ultrasound-confirmed lateral epicondylopathy
* Pain VAS ≥ 3/10 during wrist resistive extension
* No treatment response to NSAID and physiotherapy
* 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
* 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
* 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
25 Years
65 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chueh-Hung Wu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Wan-Ju Chien, M.S.
Role: primary
Other Identifiers
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201903076DIPC
Identifier Type: -
Identifier Source: org_study_id