Lateral Epicondylitis Clinical Trial
Official title:
Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis
Verified date | May 2024 |
Source | Beijing Jishuitan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | 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: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Jishuitan hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Jishuitan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mayo Elbow Performance Score | A score used to evaluated the elbow function, higher scores mean a better outcome. | 3, 6 weeks and 3, 6, 12, 24 months postoperatively | |
Secondary | Integrity of the tendon in MRI | MRI was performed to identify the status of the tendon | 3, 6, 12, 24 months postoperatively | |
Secondary | Disability of the Arm, Shoulder, and Hand (DASH) | A score used to evaluated the elbow function, higher scores mean a worse outcome. | 3, 6 weeks and 3, 6, 12, 24months postoperatively | |
Secondary | Patient-Rated Tennis Elbow Evaluation (PRTEE) scale | A score used to evaluated the elbow function, higher scores mean a worse outcome | 3, 6 weeks and 3, 6, 12, 24months postoperatively | |
Secondary | scoring system of Verhaar | A score used to evaluated the elbow function, higher scores mean a better outcome | 3, 6 weeks and 3, 6, 12, 24months postoperatively | |
Secondary | visual analog scale (VAS) | A score used to evaluated the elbow function, higher scores mean a better | 3, 6 weeks and 3, 6, 12, 24months postoperatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02308514 -
Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
|
N/A | |
Completed |
NCT02596659 -
Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow
|
N/A | |
Completed |
NCT00674622 -
Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
|
Phase 2/Phase 3 | |
Completed |
NCT06206109 -
The Effect of Tendon Tears on Lateral Epicondylitis
|
||
Completed |
NCT06301152 -
Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy
|
N/A | |
Not yet recruiting |
NCT04382144 -
Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis
|
Phase 4 | |
Recruiting |
NCT03863847 -
A Neurofeedback Treatment for Chronic Musculoskeletal Pain
|
N/A | |
Recruiting |
NCT05648032 -
PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy
|
Phase 3 | |
Completed |
NCT06300749 -
Effectiveness of Chiropractic Cervical Manipulation in Lateral Epicondylitis
|
N/A | |
Completed |
NCT00794976 -
Dexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis
|
Phase 2 | |
Completed |
NCT00888225 -
Tennis Elbow Trial
|
N/A | |
Completed |
NCT06087081 -
Mills Manipulation and Mulligan PRP Affect Pain, Grip Strength and Function on Lateral Epicondylitis
|
N/A | |
Completed |
NCT05602571 -
The Effectiveness of the Combination of PRP and ESWT in Lateral Epicondylitis
|
N/A | |
Completed |
NCT05566418 -
Immediate and Longterm Effects of Mulligan Mobilization With and Without Myofascial Release on Pain,Grip Strength and Function in Patients With Lateral Epicondylitis
|
N/A | |
Not yet recruiting |
NCT03279796 -
Treatment of Tendon Disease Using Autologous Adipose-derived Mesenchymal Stem Cells
|
Phase 2 | |
Completed |
NCT04687943 -
Comparison of PELOID Therapy and Kinesio Tape Effectiveness in Patients With Lateral Epicondylitis
|
||
Recruiting |
NCT05947968 -
Scapular PNF Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis.
|
N/A | |
Active, not recruiting |
NCT06438328 -
Effectiveness of Scapular Muscle Training in Improving Grip Strength Among Lateral Epicondylitis Patients
|
N/A | |
Completed |
NCT06317545 -
Effects of Nerchal Exercises on Lateral Epicondylitis.
|
N/A | |
Completed |
NCT05070559 -
Active Release Technique and Graston Technique in Patients With Lateral Epicondylitis
|
N/A |