Platelet Rich Plasma on Osteoarthritis of Knee

Sponsor

Yung-Tsan Wu (Other)

Overall Status

Completed

CT.gov ID

NCT02239029

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: platelet rich plasma Drug: Normal saline	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Platelet Rich Plasma on Osteoarthritis of Knee

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment. [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.
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 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tri-Service General Hospital, National Defense Medical Center,	Taipei	Neihu District	Taiwan	886

Sponsors and Collaborators

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