Lateral Epicondylitis, Rotator Cuff Syndrome
Conditions
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.
Interventions
COMBINATION_PRODUCTlyophilized 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)
OTHERlyophilized 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)
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)
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The syringe is covered.
Intervention model description
Tennis elbow Supraspinatus calcific tendinitis
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Taiwan
Contacts
Primary ContactChueh-Hung Wu, MD, PhD
Outcome results
None listed