Clinical trial NCT05648032: PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy
Official title: The Clinical Application of PLT Combined With Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lateral Epicondylitis
Rotator Cuff Syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 180
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tennis elbow Supraspinatus calcific tendinitis
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Lateral elbow pain and shoulder pain (worst in the last one week)
timeFrame: 24 weeks post-injection
Secondary outcomes:
measure: Lateral elbow pain and shoulder pain (worst in the last one week)
timeFrame: Baseline, 2, 4, 6, and 12 weeks post-injection
measure: Functional
timeFrame: Baseline, 2, 4, 6, 12, and 24 weeks post-injection
measure: Grasping power
timeFrame: Baseline, 2, 4, 6, 12, and 24 weeks post-injection
measure: Ultrasound
timeFrame: Baseline, 12 and 24 weeks post-injection
measure: Ultrasound
timeFrame: Baseline, 12 and 24 weeks post-injection
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chueh-Hung Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: