Radio-frequency Ablation in Knee Osteoarthritis by Three Needles Technique

NCT ID: NCT03613610

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-26

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Three needles group

Group Type ACTIVE_COMPARATOR

Radio-frequency ablation of genicular nerves

Intervention Type RADIATION

Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis

Single needle group

Group Type ACTIVE_COMPARATOR

Radio-frequency ablation of genicular nerves

Intervention Type RADIATION

Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis

Interventions

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Radio-frequency ablation of genicular nerves

Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alaa Fouli Gaber Ebrahim

OTHER

Sponsor Role lead

Responsible Party

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Alaa Fouli Gaber Ebrahim

Resident of anesthesia and intensive care

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Omyma Sh Mohamed, Ass. prof.

Role: STUDY_DIRECTOR

Minia University

And El raheem Ma Mohamed, Lecturer

Role: STUDY_CHAIR

Assist university

Sarah Mo Omar, Lecturer

Role: STUDY_CHAIR

Minia University

Alaa Fo Gaber, Resident

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

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Faculty of Medicine, minia university

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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60-2/2018

Identifier Type: -

Identifier Source: org_study_id

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