PRPNCT04556825
Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis
A study testing PRP and normal saline in people with PRP and Lateral Epicondylitis, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
This study is a prospective randomized controlled study of different arthroscopic treatments for refractory external humeral epicondylitis combined with platelet rich plasma (PRP) injection. The patients with intractable external humeral epicondylitis were randomly divided into groups before the operation. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- PRP, Lateral Epicondylitis
- What is being tested?
- PRP and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Jul 2024
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically diagnosed patients with refractory external humeral epicondylitis (preoperative MRI confirmed loss of ECRB integrity) patients who have received non-surgical treatment with poor efficacy
- Young and middle-aged patients aged 20 to 60, who have not previously received local injection therapy
- Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients
- No other comorbidities or medical diseases affect the surgical patients
- Unilateral disease
Who cannot join
- Early patients who have not received standard non-surgical treatment
- Patients who have received hormone injections or "small needle knife therapy" and other invasive procedures within three months before surgery, poor skin conditions, and local infections
- Elderly people older than 60 years old and patients younger than 20 years old
- Unable to accept randomization, insufficient follow-up time or lost to follow-up
- Bilateral disease
- Combined immune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis
This study is a prospective randomized controlled study of different arthroscopic treatments for refractory external humeral epicondylitis combined with platelet rich plasma (PRP) injection. The patients with intractable external humeral epicondylitis were randomly divided into groups before the operation. After the arthroscopic operation was completed, they were divided into a local PRP injection group and a control group (normal saline) to perform additional operations on the damaged tendons, each for up to half a year after the operation. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with PRP on the treatment of damaged tendons. Determine the effectiveness of PRP. At the same time, in the process of arthroscopic treatment, look for risk factors that affect the curative effect of intractable external humeral epicondylitis, as well as the causes and prevention of common complications.
- Conditions
- PRP, Lateral Epicondylitis
- Being tested
- PRP, normal saline
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPDrug
After the arthroscopic operation was completed, a local PRP with 4ml was injected
normal salineDrug
After the arthroscopic operation was completed, a local normal saline injection with same ml was performed
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Arthroscopic treatment with PRP injection Receives: Drug: PRP |
| Control group | Placebo comparator | Arthroscopic treatment with normal saline injection Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Elbow Performance Score
A score used to evaluated the elbow function, higher scores mean a better outcome.
Measured: 3, 6 weeks and 3, 6, 12, 24 months postoperatively
Secondary outcomes (5)
Integrity of the tendon in MRI
MRI was performed to identify the status of the tendon
Measured: 3, 6, 12, 24 months postoperatively
Disability of the Arm, Shoulder, and Hand (DASH)
A score used to evaluated the elbow function, higher scores mean a worse outcome.
Measured: 3, 6 weeks and 3, 6, 12, 24months postoperatively
Patient-Rated Tennis Elbow Evaluation (PRTEE) scale
A score used to evaluated the elbow function, higher scores mean a worse outcome
Measured: 3, 6 weeks and 3, 6, 12, 24months postoperatively
scoring system of Verhaar
A score used to evaluated the elbow function, higher scores mean a better outcome
Measured: 3, 6 weeks and 3, 6, 12, 24months postoperatively
visual analog scale (VAS)
A score used to evaluated the elbow function, higher scores mean a better
Measured: 3, 6 weeks and 3, 6, 12, 24months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PRPStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Lu, Beijing Jishuitan Hospital
- Investigators
- Yi Lu, Principal investigator, Sports Medicine Service, Beijing Jishuitan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556825
- Sponsor's protocol ID
- YiL
- Status last verified
- May 2024
- First submitted
- 15 Sep 2020
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li S, Yang G, Chen R, Li X, Lu Y. Use of Adjunctive Platelet-Rich Plasma for Healing During Arthroscopic Release and Repair for Recalcitrant Lateral Epicondylitis: A Prospective, Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2025 Jul;53(8):1817-1825. doi: 10.1177/03635465251341458. Epub 2025 May 31.
PubMed 40448507
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis
- ClinicalTrials.gov ID
- NCT04556825
- Acronym / sponsor ID
- YiL
- Conditions
- PRP, Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 21 Sep 2020 (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.
This study is a prospective randomized controlled study of different arthroscopic treatments for refractory external humeral epicondylitis combined with platelet rich plasma (PRP) injection. The patients with intractable external humeral epicondylitis were randomly divided into groups before the operation. After the arthroscopic operation was completed, they were divided into a local PRP injection group and a control group (normal saline) to perform additional operations on the damaged tendons, each for up to half a year after the operation. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with PRP on the treatment of damaged tendons. Determine the effectiveness of PRP. At the same time, in the process of arthroscopic treatment, look for risk factors that affect the curative effect of intractable external humeral epicondylitis, as well as the causes and prevention of common complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: PRPArthroscopic treatment with PRP injection |
| Control group | Placebo comparator | Drug: normal salineArthroscopic treatment with normal saline injection |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinically diagnosed patients with refractory external humeral epicondylitis (preoperative MRI confirmed loss of ECRB integrity) patients who have received non-surgical treatment with poor efficacy
- Young and middle-aged patients aged 20 to 60, who have not previously received local injection therapy
- Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients
- No other comorbidities or medical diseases affect the surgical patients
- Unilateral disease
Key exclusion criteria (6 listed)
- Early patients who have not received standard non-surgical treatment
- Patients who have received hormone injections or "small needle knife therapy" and other invasive procedures within three months before surgery, poor skin conditions, and local infections
- Elderly people older than 60 years old and patients younger than 20 years old
- Unable to accept randomization, insufficient follow-up time or lost to follow-up
- Bilateral disease
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 |
|---|---|---|
| PRPAfter the arthroscopic operation was completed, a local PRP with 4ml was injected | Drug | Study group |
| normal salineAfter the arthroscopic operation was completed, a local normal saline injection with same ml was performed | Drug | Control group |
Primary outcome
Mayo Elbow Performance Score
Time frame: 3, 6 weeks and 3, 6, 12, 24 months postoperatively
A score used to evaluated the elbow function, higher scores mean a better outcome.
5 secondary outcomes
Integrity of the tendon in MRI
Time frame: 3, 6, 12, 24 months postoperatively
Disability of the Arm, Shoulder, and Hand (DASH)
Time frame: 3, 6 weeks and 3, 6, 12, 24months postoperatively
Patient-Rated Tennis Elbow Evaluation (PRTEE) scale
Time frame: 3, 6 weeks and 3, 6, 12, 24months postoperatively
scoring system of Verhaar
Time frame: 3, 6 weeks and 3, 6, 12, 24months postoperatively
visual analog scale (VAS)
Time frame: 3, 6 weeks and 3, 6, 12, 24months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Derived from this study: PubMed 40448507Li S, Yang G, Chen R, Li X, Lu Y. Use of Adjunctive Platelet-Rich Plasma for Healing During Arthroscopic Release and Repair for Recalcitrant Lateral Epicondylitis: A Prospective, Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2025 Jul;53(8):1817-1825. doi: 10.1177/03635465251341458. Epub 2025 May 31.
- Individual participant dataSharing planned: No
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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.
Yi Lu principal investigator
Sports Medicine Service, Beijing Jishuitan hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP and normal saline in people with PRP and Lateral Epicondylitis, run by Beijing Jishuitan Hospital at 1 site in China.
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 5 inclusion and 6 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 28 May 2024. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mayo Elbow Performance Score (time frame: 3, 6 weeks and 3, 6, 12, 24 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556825, which also lists 1 linked publication.
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 28 May 2024.