NCT05648032

Brief Summary

PLT vs. steroid vs. PLT + steroid, which treatment is most effective in lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 14, 2022

Status Verified

April 1, 2022

Enrollment Period

2.6 years

First QC Date

November 20, 2022

Last Update Submit

December 12, 2022

Conditions

Lateral EpicondylitisRotator Cuff Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Lateral elbow pain and shoulder pain (worst in the last one week)

    Baseline, 2, 4, 6, and 12 weeks post-injection

  • Functional

    Baseline, 2, 4, 6, 12, and 24 weeks post-injection

  • Grasping power

    Baseline, 2, 4, 6, 12, and 24 weeks post-injection

  • Ultrasound

    Baseline, 12 and 24 weeks post-injection

  • Ultrasound

    Baseline, 12 and 24 weeks post-injection

Study Arms (3)

PLT (lyophilized platelet) with steroid

EXPERIMENTAL

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

PLT (lyophilized platelet)

EXPERIMENTAL

PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL normal saline, once

Other: lyophilized platelet (30ng)

Steroid

ACTIVE COMPARATOR

1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once

Drug: triamcinolone acetonide 10mg

Interventions

lyophilized platelet (30ng) and triamcinolone acetonide 10mgCOMBINATION_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)

Also known as: PLT and steroid
PLT (lyophilized platelet) with steroid
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)

Also known as: Blood product
PLT (lyophilized platelet)
triamcinolone acetonide 10mgDRUG

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)

Also known as: steroid
Steroid

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Hawkins-Kennedy test or empty can test, one of which is positive
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Triamcinolone AcetonideSteroids

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Chueh-Hung Wu, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chueh-Hung Wu, MD, PhD

CONTACT

886-2-23123456nojred@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The syringe is covered.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Tennis elbow Supraspinatus calcific tendinitis
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2022

First Posted

December 13, 2022

Study Start

October 6, 2022

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

December 14, 2022

Record last verified: 2022-04

Locations

TW(1)