The Effect of Multiple Injection of Platlet-rich Plasma in Chronic Patellar Tendinopathy
Study Details
Study Description
Brief Summary
According to previous studies, the effect of PRP to patellar tendinopathy could last longer. However, the type, concentration, time and frequent of injection are still debated。 This study is to understand the effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy and to analyze the relation between efficacy of PRP and the growth factor in PRP.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Patellar tendinopathy, also known as jumper's knee，is clinically common characterised by anterior knee pain, activity-related pain、local tenderness over inferior pole of patella. The discomfort can result in decreasing athletic performance and be one of the most challenge for sports medicine doctor.
The patellar tendon suffer from repetitive microtrauma，result in reactive patellar tendinopathy. The overload tendon combining with risk factors of patellar tendinopathy will not recover timely and progress to chronic patellar tendinopathy. Hence, to reverse the progression is our aim.
According to previous studies, several nonsurgical treatment options have been proposed such as medication, eccentric exercise, corticosteroid injection, shockwave and platelet-rich plasma (PRP). Among all the options, the effect of PRP could last longer. However, the type, concentration, time and frequent of injection are still debated。Moreover, there is no study about the relationship between efficacy and the ratio and concentration of growth factor in the PRP.
The aim of this study is to understand (1) The effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy. (2) The effect of leukocyte-rich PRP in chronic patellar tendinopathy (3) Analyze the relation between efficacy of PRP and the growth factor in PRP.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PRP injection, once PRP injection, once |
Biological: Platlet-rich plasma
Multiple Platlet-rich plasma injection.
|
| Experimental: PRP injection, twice PRP injection, twice, 2 weeks apart |
Biological: Platlet-rich plasma
Multiple Platlet-rich plasma injection.
|
| Experimental: PRP injection, 3 times PRP injection, 3 times, 2 weeks apart |
Biological: Platlet-rich plasma
Multiple Platlet-rich plasma injection.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline Victorian Institute of Sport Assessment (VISA-P) score to 36 weeks [36 weeks]
Clinical evaluation for patellar tendinopathy minimum score: 0(worse outcome) maximum score: 100(better outcome)
- Change from baseline modified Blazina Scale to 36 weeks [36 weeks]
Clinical evaluation for patellar tendinopathy Stage 0 - No pain Stage 1 - Pain only after intense sports activity; no undue functional impairment Stage 2 - Pain at the beginning and after sports activity; still able to perform at a satisfactory level Stage 3 - Pain during sports activity; increasing difficulty in performing at a satisfactory level Stage 4 - Pain during sports activity; unable to participate in sport at a satisfactory level Stage 5 - Pain during daily activity; unable to participate in sport at any level
- Change from baseline thickness of patellar tendon to 36 weeks [36 weeks]
Sonographic evaluation for patellar tendinopathy to measure the thickness of proximal patellar tendon.
- Change from baseline Visual analogue score(VAS) to 36 weeks [36 weeks]
evaluation for pain(minimal score:0, maximal score:10)
Secondary Outcome Measures
- Correlation between Platlet derived growth factor (PDGF) and VISA-P score [36 weeks]
Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(PDGF)
- Correlation between Transforming growth factor beta 1 (TGF beta 1) and VISA-P score [36 weeks]
Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(TGF beta 1)
- Correlation between Epithelial growth factor (EGF) and VISA-P score [36 weeks]
Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(EGF)
- Change from baseline Victorian Institute of Sport Assessment (VISA) score to 104 weeks [104 weeks]
To evaluate the longterm effect of multiple PRP injection
Eligibility Criteria
Criteria
Inclusion Criteria:
Chronic patellar tendinopathy
Exclusion Criteria:
-
Corticosteroid injections within 12 months
-
Previous knee surgery
-
Any confounding diagnosis to the knee joint
-
Arthritis
-
Rheumatoid arthritis
-
Diabetes
-
Infections of knee joint
-
NSAIDs in the 10 days before the procedure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taoyuan Chang Gung Memorial Hospital | Taoyuan | Taiwan | 333 |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201900117A3