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Active, not recruitingNCT04556825Updated May 28, 2024

Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis

An interventional study of PRP and normal saline in PRP and Lateral Epicondylitis, sponsored by Beijing Jishuitan Hospital. Active, not recruiting at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by Beijing Jishuitan Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • PRP
  • Lateral Epicondylitis

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03

In context

Tennis Elbow

284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.

This study's enrollment of 80 is above the median of 50 across 253 interventional studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

Beijing Jishuitan Hospital is the lead sponsor of 43 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Study group

    Arthroscopic treatment with PRP injection

    Drug: PRP

  • Placebo comparator
    Control group

    Arthroscopic treatment with normal saline injection

    Drug: normal saline

Interventions

  • DrugPRP

    After the arthroscopic operation was completed, a local PRP with 4ml was injected

  • Drugnormal saline

    After the arthroscopic operation was completed, a local normal saline injection with same ml was performed

06

What researchers measure

Primary outcomes

  1. Mayo Elbow Performance Score

    A score used to evaluated the elbow function, higher scores mean a better outcome.

    Time frame: 3, 6 weeks and 3, 6, 12, 24 months postoperatively

Secondary outcomes

  1. Integrity of the tendon in MRI

    MRI was performed to identify the status of the tendon

    Time frame: 3, 6, 12, 24 months postoperatively

  2. Disability of the Arm, Shoulder, and Hand (DASH)

    A score used to evaluated the elbow function, higher scores mean a worse outcome.

    Time frame: 3, 6 weeks and 3, 6, 12, 24months postoperatively

  3. Patient-Rated Tennis Elbow Evaluation (PRTEE) scale

    A score used to evaluated the elbow function, higher scores mean a worse outcome

    Time frame: 3, 6 weeks and 3, 6, 12, 24months postoperatively

  4. scoring system of Verhaar

    A score used to evaluated the elbow function, higher scores mean a better outcome

    Time frame: 3, 6 weeks and 3, 6, 12, 24months postoperatively

  5. visual analog scale (VAS)

    A score used to evaluated the elbow function, higher scores mean a better

    Time frame: 3, 6 weeks and 3, 6, 12, 24months postoperatively

07

Study locations

1 site
  • Beijing Jishuitan hospital
    Beijing, Beijing 100000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04556825
Lead sponsor
Beijing Jishuitan Hospital
Responsible party
Yi Lu (Director of Sports Medicine Service of Beijing Jishuitan hospital, Beijing Jishuitan Hospital) — Principal investigator
First posted
Sep 21, 2020
Start date
Jul 1, 2020
Primary completion
Jul 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
May 28, 2024

Study contacts

Yi Lu
principal investigator · Sports Medicine Service, Beijing Jishuitan hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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