NCT02141529

Brief Summary

The purpose of this study is to determine whether bipolar intraarticular pulsed radiofrequency method has a superiority to unipolar mode in the treatment of chronic knee pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

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

May 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

1.6 years

First QC Date

May 15, 2014

Last Update Submit

March 15, 2016

Conditions

Osteoarthritis

Keywords

Intraarticularpulsed radiofrequencyosteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale scores to measure the pain degree

    12 weeks

Secondary Outcomes (1)

  • WOMAC scores to measure the degree of quality of life and the functional response of treatment of patients

    12 weeks

Study Arms (2)

Unipolar PRF

ACTIVE COMPARATOR

Unipolar pulsed radiofrequency thermocoagulation, intraarticularly in knee joint, 42oC of temperature during ten minutes

Procedure: Unipolar pulsed radiofrequency thermocoagulation

Bipolar PRF

EXPERIMENTAL

Bipolar pulsed radiofrequency thermocoagulation, intraarticularly in knee joint, 42oC of temperature during ten minutes

Procedure: Bipolar pulsed radiofrequency thermocoagulation

Interventions

Unipolar pulsed radiofrequency thermocoagulationPROCEDURE

Unipolar pulsed radiofrequency thermocoagulation, intraarticular administration into the knee joint

Unipolar PRF
Bipolar pulsed radiofrequency thermocoagulationPROCEDURE

Bipolar pulsed radiofrequency thermocoagulation, intraarticular administration into the knee joint

Bipolar PRF

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 20-70 years
  • Patients with osteoarthritis having knee pain over 3 months

You may not qualify if:

  • Chronic knee pain caused by infection, inflammation, tumors, and fractures
  • A history of acute knee pain, previous knee surgery, connective tissue diseases, neurologic or psychiatric disorders,
  • The administration of steroids or hyaluronic acids within the last three months
  • Coagulation disorders
  • Local infection at the site of intervention planned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University Faculty of Medicine Research Hospital

Adana, 01130, Turkey (Türkiye)

Location

Related Publications (5)

  • Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

    PMID: 3068365RESULT

  • Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.

    PMID: 15639634RESULT

  • Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.

    PMID: 21055873RESULT

  • Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. No abstract available.

    PMID: 18211593RESULT

  • Gulec E, Ozbek H, Pektas S, Isik G. Bipolar Versus Unipolar Intraarticular Pulsed Radiofrequency Thermocoagulation in Chronic Knee Pain Treatment: A Prospective Randomized Trial. Pain Physician. 2017 Mar;20(3):197-206.

    PMID: 28339432DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ersel Gulec, Assist.Prof.

    Cukurova University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.

Study Record Dates

First Submitted

May 15, 2014

First Posted

May 19, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations

TU(1)