NCT04387396

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2020

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

October 24, 2019

Last Update Submit

February 15, 2021

Conditions

Knee Osteoarthritis

Keywords

Knee OsteoarthritisPlatelet rich plasmaExercise

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline, six week

Study Arms (2)

Physiotherapy

EXPERIMENTAL

Exercise intervention will be applied to this arm.

Other: Exercise

Control

NO INTERVENTION

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

Interventions

ExerciseOTHER

Exercise specific to knee osteoarthritis.

Physiotherapy

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Samanpazari, 06100, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 11014340BACKGROUND

  • 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.

    PMID: 13610976BACKGROUND

  • 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.

    PMID: 18687280BACKGROUND

  • 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.

    PMID: 25416198BACKGROUND

  • 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.

    PMID: 22397710BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Feza Korkusuz, Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD(c)

Study Record Dates

First Submitted

October 24, 2019

First Posted

May 13, 2020

Study Start

August 1, 2019

Primary Completion

December 29, 2020

Study Completion

December 29, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)