Lateral EpicondylitisPhase 3NCT05648032
PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy
A Phase 3 study testing lyophilized platelet (30ng) and triamcinolone acetonide 10mg, lyophilized platelet (30ng) and triamcinolone acetonide 10mg in people with Lateral Epicondylitis and Rotator Cuff Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
PLT vs. steroid vs. PLT + steroid, which treatment is most effective in lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Lateral Epicondylitis, Rotator Cuff Syndrome
- What is being tested?
- lyophilized platelet (30ng) and triamcinolone acetonide 10mg, lyophilized platelet (30ng) and triamcinolone acetonide 10mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Oct 2022to 30 Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Wan-Ju Chien, M.S., 886-2-23123456 ext. 266473, wanzu21@gmail.com
Chueh-Hung Wu, MD, PhD
About this study
Official title: The Clinical Application of PLT Combined With Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy
PLT vs. steroid vs. PLT + steroid, which treatment is most effective in lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis.
Read the 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.
- Conditions
- Lateral Epicondylitis, Rotator Cuff Syndrome
- Being tested
- lyophilized platelet (30ng) and triamcinolone acetonide 10mg, lyophilized platelet (30ng), triamcinolone acetonide 10mg
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lyophilized platelet (30ng) and triamcinolone acetonide 10mgCombination product
Also called PLT and steroid
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)
lyophilized platelet (30ng)Other
Also called Blood product
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)
triamcinolone acetonide 10mgDrug
Also called steroid
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)
| Study group | Role | What they receive |
|---|---|---|
| PLT (lyophilized platelet) with steroid | Experimental | PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once Receives: 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 Receives: Other: lyophilized platelet (30ng) |
| Steroid | Active comparator | 1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once Receives: Drug: triamcinolone acetonide 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral elbow pain and shoulder pain (worst in the last one week)
Visual analogue scale (0-10, the high the worse)
Measured: 24 weeks post-injection
Secondary outcomes (5)
Lateral elbow pain and shoulder pain (worst in the last one week)
Visual analogue scale (0-10, the high the worse)
Measured: Baseline, 2, 4, 6, and 12 weeks post-injection
Functional
Disabilities of the Arm, Shoulder, and Hand (Score 0-100, the high the worse)
Measured: Baseline, 2, 4, 6, 12, and 24 weeks post-injection
Grasping power
Grasping power
Measured: Baseline, 2, 4, 6, 12, and 24 weeks post-injection
Ultrasound
Tendon thickness (mm)
Measured: Baseline, 12 and 24 weeks post-injection
Ultrasound
Calcification size (mm)
Measured: Baseline, 12 and 24 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start6 Oct 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tennis elbow Supraspinatus calcific tendinitis
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chueh-Hung Wu, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648032
- Sponsor's protocol ID
- 201903076DIPC
- Status last verified
- Apr 2022
- First submitted
- 20 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application of PLT Combined With Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy
- ClinicalTrials.gov ID
- NCT05648032
- Acronym / sponsor ID
- 201903076DIPC
- Conditions
- Lateral Epicondylitis, Rotator Cuff Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Tennis elbow Supraspinatus calcific tendinitis
| Arm | Type | Receives |
|---|---|---|
| PLT (lyophilized platelet) with steroid | Experimental | Combination Product: lyophilized platelet (30ng) and triamcinolone acetonide 10mgPLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once |
| PLT (lyophilized platelet) | Experimental | Other: lyophilized platelet (30ng)PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL normal saline, once |
| Steroid | Active comparator | Drug: triamcinolone acetonide 10mg1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Hawkins-Kennedy test or empty can test, one of which is positive
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lyophilized platelet (30ng) and triamcinolone acetonide 10mgAlso: PLT and steroidUltrasound-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) | Combination product | PLT (lyophilized platelet) with steroid |
| lyophilized platelet (30ng)Also: Blood productUltrasound-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 | PLT (lyophilized platelet) |
| triamcinolone acetonide 10mgAlso: steroidUltrasound-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) | Drug | Steroid |
Primary outcome
Lateral elbow pain and shoulder pain (worst in the last one week)
Time frame: 24 weeks post-injection
Visual analogue scale (0-10, the high the worse)
5 secondary outcomes
Lateral elbow pain and shoulder pain (worst in the last one week)
Time frame: Baseline, 2, 4, 6, and 12 weeks post-injection
Functional
Time frame: Baseline, 2, 4, 6, 12, and 24 weeks post-injection
Grasping power
Time frame: Baseline, 2, 4, 6, 12, and 24 weeks post-injection
Ultrasound
Time frame: Baseline, 12 and 24 weeks post-injection
Ultrasound
Time frame: Baseline, 12 and 24 weeks post-injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chueh-Hung Wu, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lyophilized platelet (30ng) and triamcinolone acetonide 10mg, lyophilized platelet (30ng) and triamcinolone acetonide 10mg in people with Lateral Epicondylitis and Rotator Cuff Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chueh-Hung Wu, MD, PhD (886-2-23123456 ext. 266473, nojred@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lateral elbow pain and shoulder pain (worst in the last one week) (time frame: 24 weeks post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.