Radio-frequency Ablation in Knee Osteoarthritis by Three Needles Technique

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03613610
• Other study ID #: 60-2/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: November 2018

Study information

• Verified date: August 2018
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Radiation:
• Radio-frequency ablation of genicular nerves
Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, minia university	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Alaa Fouli Gaber Ebrahim

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue score	Pain intensity via the visual analogue score (VAS).	6 months after the procedure
Primary	Oxford knee score	Follow up of pain and function via the Oxford knee score	6 months after the procedure
Secondary	Failure rate	Persistence of pain after the procedure	6 months after the procedure
Secondary	Incidence of complication	Any infection, heamatoma	6 months after the procedure