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PLT vs. steroid vs. PLT + steroid, which treatment is most effective in lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLT (lyophilized platelet) with steroid | Experimental | PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once |
|
| PLT (lyophilized platelet) | Experimental | PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL normal saline, once |
|
| Steroid | Active Comparator | 1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lyophilized platelet (30ng) and triamcinolone acetonide 10mg | Combination Product | 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) |
| 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 |
| 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) | Baseline, 2, 4, 6, and 12 weeks post-injection |
| Functional | Disabilities of the Arm, Shoulder, and Hand (Score 0-100, the high the worse) |
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Lateral epicondylitis
Inclusion Criteria:
Exclusion Criteria:
Supraspinatus calcific tendinis
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chueh-Hung Wu, MD, PhD | Contact | 886-2-23123456 | 266473 | nojred@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chueh-Hung Wu, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
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Tennis elbow Supraspinatus calcific tendinitis
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The syringe is covered.
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|
| lyophilized platelet (30ng) | Other | 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 | Drug | 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) |
|
|
| 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 |
| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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