PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy
Study Details
Study Description
Brief Summary
PLT vs. steroid vs. PLT + steroid, which treatment is most effective in lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Tendon thickness (mm)
- Ultrasound [Baseline, 12 and 24 weeks post-injection]
Calcification size (mm)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Chueh-Hung Wu, MD, PhD, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201903076DIPC