Radio-frequency Ablation in Knee Osteoarthritis by Three Needles Technique

Three Needles Approach... A New Technique of Genicular Nerve Radio-frequency Ablation for Pain Relief in Advanced Knee Osteoarthritis

The study is designed to evaluate and compare the efficacy of three needles approach as a new technique in radiofrequency neurotomy of genicular nerve versus the traditional single needle approach as a treatment of advanced knee osteoarthritic pain. Primary outcome:

1. Pain intensity via the visual analogue score (VAS).
2. Function and pain via the Oxford Knee Score. Evaluated after 6 months of the procedure

Secondary outcome:

1. Failure rate.
2. Incidence of any complication.
3. Total analgesic requirement during the period of follow up.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Radiation: Radio-frequency ablation of genicular nerves

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61111
    • Faculty of Medicine, Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1- Age 35-85 years old 2- Patients with stage 3 or higher OA-related radiological changes based on Kellgren-Lawrence (K/L) rating scale 3- Knee pain for at least 3 months 4-Patients are clinically unresponsive to conservative treatment modalities (physical therapy and rehabilitation practices, orally administered analgesics and anti-inflammatory drugs).

Exclusion Criteria:

• 1- Patients with other causes of pain as radiculopathy, neurological disorders or intermittent claudication. 2- Previous knee trauma. 3- Previous knee surgery. 4- Patients received intra-articular injection during the previous three months.

  5- Acute knee pain. 6- Crystal arthropathy. 7- Joint effusion. 8- Serious neurological or psychiatric disorders. 9- On anticoagulant medication. 10- Any other connective tissue disorder that affects the knee joint. 11- skin infection at the site of injection. 12-patient refusal.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Three needles group	Radiation: Radio-frequency ablation of genicular nerves; Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis
Active Comparator: Single needle group	Radiation: Radio-frequency ablation of genicular nerves; Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue score	Pain intensity via the visual analogue score (VAS).	6 months after the procedure
Oxford knee score	Follow up of pain and function via the Oxford knee score	6 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure rate	Persistence of pain after the procedure	6 months after the procedure
Incidence of complication	Any infection, heamatoma	6 months after the procedure

Collaborators and Investigators

• Sponsor: Alaa Fouli Gaber Ebrahim
• Investigators: Study Director: Omyma Sh Mohamed, Ass. prof., Minia University; Study Chair: And El raheem Ma Mohamed, Lecturer, Assist university; Study Chair: Sarah Mo Omar, Lecturer, Minia University; Principal Investigator: Alaa Fo Gaber, Resident, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2018
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Genicular nerve radio-frequency ablation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 60-2/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No