search
Back to results

PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy

Primary Purpose

Lateral Epicondylitis, Rotator Cuff Syndrome

Status
Recruiting
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
lyophilized platelet (30ng) and triamcinolone acetonide 10mg
lyophilized platelet (30ng)
triamcinolone acetonide 10mg
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

PLT (lyophilized platelet) with steroid

PLT (lyophilized platelet)

Steroid

Arm Description

PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once

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

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

Outcomes

Primary Outcome Measures

Lateral elbow pain and shoulder pain (worst in the last one week)
Visual analogue scale (0-10, the high the worse)

Secondary Outcome Measures

Lateral elbow pain and shoulder pain (worst in the last one week)
Visual analogue scale (0-10, the high the worse)
Functional
Disabilities of the Arm, Shoulder, and Hand (Score 0-100, the high the worse)
Grasping power
Grasping power
Ultrasound
Tendon thickness (mm)
Ultrasound
Calcification size (mm)

Full Information

First Posted
November 20, 2022
Last Updated
December 12, 2022
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05648032
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Rotator Cuff Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Tennis elbow Supraspinatus calcific tendinitis
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The syringe is covered.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PLT (lyophilized platelet) with steroid
Arm Type
Experimental
Arm Description
PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once
Arm Title
PLT (lyophilized platelet)
Arm Type
Experimental
Arm Description
PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL normal saline, once
Arm Title
Steroid
Arm Type
Active Comparator
Arm Description
1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once
Intervention Type
Combination Product
Intervention Name(s)
lyophilized platelet (30ng) and triamcinolone acetonide 10mg
Other Intervention Name(s)
PLT and steroid
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
lyophilized platelet (30ng)
Other Intervention Name(s)
Blood product
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide 10mg
Other Intervention Name(s)
steroid
Intervention Description
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)
Primary Outcome Measure Information:
Title
Lateral elbow pain and shoulder pain (worst in the last one week)
Description
Visual analogue scale (0-10, the high the worse)
Time Frame
24 weeks post-injection
Secondary Outcome Measure Information:
Title
Lateral elbow pain and shoulder pain (worst in the last one week)
Description
Visual analogue scale (0-10, the high the worse)
Time Frame
Baseline, 2, 4, 6, and 12 weeks post-injection
Title
Functional
Description
Disabilities of the Arm, Shoulder, and Hand (Score 0-100, the high the worse)
Time Frame
Baseline, 2, 4, 6, 12, and 24 weeks post-injection
Title
Grasping power
Description
Grasping power
Time Frame
Baseline, 2, 4, 6, 12, and 24 weeks post-injection
Title
Ultrasound
Description
Tendon thickness (mm)
Time Frame
Baseline, 12 and 24 weeks post-injection
Title
Ultrasound
Description
Calcification size (mm)
Time Frame
Baseline, 12 and 24 weeks post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chueh-Hung Wu, MD, PhD
Phone
886-2-23123456
Ext
266473
Email
nojred@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chueh-Hung Wu, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan-Ju Chien, M.S.
Phone
886-2-23123456
Ext
266473
Email
wanzu21@gmail.com
First Name & Middle Initial & Last Name & Degree
Chueh-Hung Wu, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy

We'll reach out to this number within 24 hrs