Platelet Rich Plasma on Osteoarthritis of Knee

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: platelet rich plasma; Drug: Normal saline

• Registration Number: NCT02239029
• Lead Sponsor: Yung-Tsan Wu

Brief Summary

Although few studies have showed beneficial effect of platelet rich plasma (PRP) for osteoarthritis of knee (OA knee), only one study applied randomized, control method and none of them has the objective measurements such as balance test or muscle strength which were reported as decrease in patients with OA knees. We assess the analgesic effect and the extent of improved muscle strength and balance after PRP in patients with OA knee.

Detailed Description

Patients with bilateral OA knee will be enrolled and randomized into intervention and control knee. One dose of PRP is applied in the intervention knee and normal saline in control side. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and isokinetic strengthening test at different follow-up frame (2nd week, 1st month, 3rd month and 6th month after treatment).

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-12
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-04
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age between 35 to 75 y/o.
2. Alert consciousness
3. Symptom of knee osteoarthritis persist at least 6 months and stage I or II scored by Ahlbäck grading system
4. The pain score measured by VAS at least 4 points

Exclusion Criteria

1. Has received hyaluronic acid or steroid injection within 6 monts
2. Has received NSAIDs or steroid within one week
3. Tumor or metastasis surrounding the knee joint
4. Has received total knee replacement, major surgery in knee, rheumatoid arthritis
5. Patient who cant tolerance the balance or muscle strength test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet rich plasma	platelet rich plasma	Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Patients with bilaetral knee osteoarthritis randomized receive on dose of PRP in one knee and placebo with normal saline in the other side.
normal saline	Normal saline	Normal saline was injected into the other side of knee as the control group.

Primary Outcome Measures

Name	Time	Method
Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP.	Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP.	Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in balance function on 2nd week, 1st month, 3rd month and 6th month after treatment.	Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.	Using the balance test (Biodex) to measure the balance function before treatment and multiple time frame after treatment.
Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.	Pre-treatment and 2nd week, 1st month, 3rd month and 6th month after treatment.	Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Change from baseline in muscle strength of lower extremities on 2nd week, 1st month, 3rd month and 6th month after treatment.	Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.	Using the isokinetic strengthening test to measure the muscle strength of lower extremities before treatment and multiple time frame after treatment.

Trial Locations

Locations (1)

Tri-Service General Hospital, National Defense Medical Center,; 🇨🇳 Taipei, Neihu District, Taiwan