Platelet Rich Plasma on Osteoarthritis of Knee

December 4, 2016 updated by: Yung-Tsan Wu

The Effect of Platelet Rich Plasma on Osteoarthritis of Knee

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Neihu District
      • Taipei, Neihu District, Taiwan, 886
        • Tri-Service General Hospital, National Defense Medical Center,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: platelet rich plasma
Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.
Placebo Comparator: normal saline
Normal saline was injected into the other side of knee as the control group.
Drug: Normal saline
The normal salin as the placebo intervention was injection in the other side of knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP.
Time Frame: 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.
Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
Time Frame: Pre-treatment, on 2nd week, 1st month, 3rd month and 6th month after treatment..
Using the Lequesne's severity index to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Pre-treatment, on 2nd week, 1st month, 3rd month and 6th month after treatment..
Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
Time Frame: 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.
Pre-treatment and 2nd week, 1st month, 3rd month and 6th month after treatment.
Change from baseline in balance function on 2nd week, 1st month, 3rd month and 6th month after treatment.
Time Frame: 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.
Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.
Change from baseline in muscle strength of lower extremities on 2nd week, 1st month, 3rd month and 6th month after treatment.
Time Frame: 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.
Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yung-Tsan Wu

Investigators

  • Principal Investigator: Liang-Cheng Chen, MD, MS, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 4, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSGHIRB-2-103-05-075
  • TSGHIRB-2-103-05-075, Taiwan (Other Grant/Funding Number: TSGHIRB-2-103-05-075, Taiwan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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