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Radiofrequency Neurotomy In Relieving 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: NCT03224637
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Emad Zarief , MD, Assiut University

Brief Summary:
Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Pain, Chronic Procedure: radiofrequency Drug: Paracetamol (conventional) Drug: Ketorolac Tromethamine (conventional) Not Applicable

Detailed Description:
Osteoarthritis (OA) is commonest chronic arthritis affecting patients usually aged above 45 years. OA decreased health-related quality of life and increased economic costs. Radiofrequency (RF), was used for the treatment of chronic pain unresponsive to conservative therapies. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic Knee Osteoarthritis : A Single-blind Randomized Controlled Trial.
Actual Study Start Date : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: radiofrequency group
radiofrequency was done in the three genicular nerves upper medial and upper lateral and lower medial
Procedure: radiofrequency
radiofrequency done in the three genicular nerves upper medial and upper lateral and lower medial

Active Comparator: conventional group
the patients received conventional paracetamol and non steroidal antiinflammatory
Drug: Paracetamol (conventional)
Drug: Ketorolac Tromethamine (conventional)



Primary Outcome Measures :
  1. pain assessment by VAS scale [ Time Frame: 6 months ]
    assessing pain by VAS scale


Secondary Outcome Measures :
  1. patient satisfaction by Likert scale [ Time Frame: 6 months ]
    Likert scale to assess patients satisfaction

  2. patient disability by Western Ontario McMaster Universities OA index [ Time Frame: 6 months ]
    Western Ontario McMaster Universities OA index to assess disability



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic arthritis according to the American College of Rheumatology criteria
  • diagnosed radiologically patients in stage 3 and 4, according to the Kellgren-Lawrence classification

Exclusion Criteria:

  • other causes of pain such as radiculopathy, neurological disorders, or intermittent claudication.
  • patients receive intraarticular steroid or hyaluronic acids during previous three months.
  • patients did previous knee surgery.
  • Patients with general contraindication to the application of invasive intervention such as hemorrhage, coagulation disorder, systemic infection or local infection.
  • patients with other connective tissue disease affecting the knee. And 6-psychiatric disorders.

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): NCT03224637


Locations
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Egypt
Emad Zarief Kamel Said
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emad Zarief , MD, Lecturer of Anesthesia and ICU, Assiut University
ClinicalTrials.gov Identifier: NCT03224637    
Other Study ID Numbers: IRB00009913
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Chronic Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Rheumatic Diseases
Acetaminophen
Ketorolac
Ketorolac Tromethamine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action