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Intraarticular Pulse Radiofrequency to Treat Chronic Knee Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02141529
Recruitment Status : Completed
First Posted : May 19, 2014
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Ersel GULEC, Cukurova University

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Unipolar pulsed radiofrequency thermocoagulation Procedure: Bipolar pulsed radiofrequency thermocoagulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Bipolar Versus Unipolar Intraarticular Pulsed Radiofrequency Thermocoagulation in Chronic Knee Pain Treatment: A Prospective Randomized Study
Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Unipolar PRF
Unipolar pulsed radiofrequency thermocoagulation, intraarticularly in knee joint, 42oC of temperature during ten minutes
Procedure: Unipolar pulsed radiofrequency thermocoagulation
Unipolar pulsed radiofrequency thermocoagulation, intraarticular administration into the knee joint

Experimental: Bipolar PRF
Bipolar pulsed radiofrequency thermocoagulation, intraarticularly in knee joint, 42oC of temperature during ten minutes
Procedure: Bipolar pulsed radiofrequency thermocoagulation
Bipolar pulsed radiofrequency thermocoagulation, intraarticular administration into the knee joint




Primary Outcome Measures :
  1. Visual Analog Scale scores to measure the pain degree [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. WOMAC scores to measure the degree of quality of life and the functional response of treatment of patients [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141529


Locations
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Turkey
Cukurova University Faculty of Medicine Research Hospital
Adana, Turkey, 01130
Sponsors and Collaborators
Cukurova University
Investigators
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Principal Investigator: Ersel Gulec, Assist.Prof. Cukurova University Faculty of Medicine
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ersel GULEC, Assist.Prof., Cukurova University
ClinicalTrials.gov Identifier: NCT02141529    
Other Study ID Numbers: IAPRF01
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by Ersel GULEC, Cukurova University:
Intraarticular
pulsed radiofrequency
osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases