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Investigation of the Effects of Physiotherapy in Patients With Platelet Rich Plasma (PRP) Applied Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Platelet rich plasma, Exercise

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Grade 2-3 according to Kellgren Lawrence osteoarthritis classification,
Patients with knee osteoarthritis who underwent PRP injection at least three days ago,
Being volunteer

Exclusion Criteria:

Any intra-articular application and / or physiotherapy and rehabilitation in the last 6 months,
Have any other orthopedic problems involving the lower extremities
Having cognitive problems,
Having additional neurological, rheumatologic and / or oncological problems

Sites / Locations

Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physiotherapy

Control

Arm Description

Exercise intervention will be applied to this arm.

No intervention will be made to this arm, only evaluations will be made.

Outcomes

Primary Outcome Measures

Change from Baseline Pain Level at Six Week

Pain change will be measured throughout Study and Follow-up with Visual Analog Scale. This scale is a 100 millimeter line drawn horizontally on an A4 sheet of paper. The left end of the line shows "no pain at all", the right end shows "my pain is as bad as it could be", while the remaining part shows the intermediate values. So minimum score was 0, and maximum score was 100. The patient is asked to mark the severity of the pain on the chart. Validity and reliability were made. The minimal clinical significance difference in chronic low back pain was 20 millimeters.

Secondary Outcome Measures

Full Information

NCT ID

NCT04387396

First Posted

October 24, 2019

Last Updated

February 15, 2021

Sponsor

Hacettepe University

1. Study Identification

Unique Protocol Identification Number

NCT04387396

Brief Title

Investigation of the Effects of Physiotherapy in Patients With Platelet Rich Plasma (PRP) Applied Knee Osteoarthritis

Official Title

Investigation of the Effects of Physiotherapy on Pain, Physical Function and Quality of Life in Patients With PRP Applied Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

December 29, 2020 (Actual)

Study Completion Date

December 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study evaluates effects of PRP and physiotherapy on pain, physical function and quality of life in patients with knee osteoarthritis.

Detailed Description

PRP has been reported to have a low to moderate level of evidence in patients with knee osteoarthritis (OA) in reducing pain and improving function. Similarly, in individuals with knee osteoarthritis, exercise has been reported to be effective in reducing the pain and improving physical function of the knee OA patient in the short term, and may be even more effective with individual exercise programs. However, there is no study examining the effect of PRP and exercise together. PRP and exercise can be more effective together. The aim of our study was to investigate the effects of physiotherapy on pain, physical function and quality of life in patients with knee OA who underwent PRP injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

Knee Osteoarthritis, Platelet rich plasma, Exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physiotherapy

Arm Type

Experimental

Arm Description

Exercise intervention will be applied to this arm.

Arm Title

Control

Arm Type

No Intervention

Arm Description

No intervention will be made to this arm, only evaluations will be made.

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

Exercise specific to knee osteoarthritis.

Primary Outcome Measure Information:

Title

Change from Baseline Pain Level at Six Week

Description

Time Frame

At baseline, six week

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Grade 2-3 according to Kellgren Lawrence osteoarthritis classification, Patients with knee osteoarthritis who underwent PRP injection at least three days ago, Being volunteer Exclusion Criteria: Any intra-articular application and / or physiotherapy and rehabilitation in the last 6 months, Have any other orthopedic problems involving the lower extremities Having cognitive problems, Having additional neurological, rheumatologic and / or oncological problems

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Feza Korkusuz, Prof.

Organizational Affiliation

Hacettepe University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hacettepe University

City

Ankara

State/Province

Samanpazari

ZIP/Postal Code

06100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11014340

Citation

Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.

Results Reference

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PubMed Identifier

13610976

Citation

MILLER JH, WHITE J, NORTON TH. The value of intra-articular injections in osteoarthritis of the knee. J Bone Joint Surg Br. 1958 Nov;40-B(4):636-43. doi: 10.1302/0301-620X.40B4.636. No abstract available.

Results Reference

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PubMed Identifier

18687280

Citation

Bennell KL, Hunt MA, Wrigley TV, Lim BW, Hinman RS. Role of muscle in the genesis and management of knee osteoarthritis. Rheum Dis Clin North Am. 2008 Aug;34(3):731-54. doi: 10.1016/j.rdc.2008.05.005.

Results Reference

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PubMed Identifier

25416198

Citation

Laudy AB, Bakker EW, Rekers M, Moen MH. Efficacy of platelet-rich plasma injections in osteoarthritis of the knee: a systematic review and meta-analysis. Br J Sports Med. 2015 May;49(10):657-72. doi: 10.1136/bjsports-2014-094036. Epub 2014 Nov 21.

Results Reference

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PubMed Identifier

22397710

Citation

Chang TF, Liou TH, Chen CH, Huang YC, Chang KH. Effects of elastic-band exercise on lower-extremity function among female patients with osteoarthritis of the knee. Disabil Rehabil. 2012;34(20):1727-35. doi: 10.3109/09638288.2012.660598. Epub 2012 Mar 8.

Results Reference

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Investigation of the Effects of Physiotherapy in Patients With Platelet Rich Plasma (PRP) Applied Knee Osteoarthritis

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