Ultrasound-guided Genicular Nerve Block With Phenol for the Treatment of Chronic Pain Due to Knee Osteoarthritis

July 24, 2018 updated by: Leonardo Henrique Cunha Ferraro, Federal University of São Paulo

Prospective Study of the Efficacy of Ultrasound-guided Genicular Nerve Block With Phenol for the Treatment of Chronic Pain Due to Knee Osteoarthritis

Osteoarthritis (OA) is one of the most frequent causes of chronic pain, often intense, debilitating and responsible for a large percentage of the elderly. The disease affects about 10% of adults and the knees are the most affected joints. The diagnosis of OA in the knee is predominantly clinical, and can be confirmed by radiological examination. Systemic drugs are indicated before invasive procedures, but pharmacological therapies may offer limited benefits. Thermal radiofrequency lesions of genicular nerves has been used to relieve chronic knee pain, as adjuvant therapy, but with high costs and low availability in the public system. The use of phenol for peripheral analgesic blocks has emerged as a good option and at low cost and can be used in any service of Pain Treatment. The aim of the study is to evaluate the efficacy of 6% phenol for ultrasound-guided genicular nerves neurolysis for the treatment of patients with chronic knee pain due to osteoarthritis.

METHODS: A prospective study will be carried out with 15 patients with chronic pain (more than 4 months) and diagnosis of arthrosis by imaging, with pain intensity greater than 4 (from zero to 10) that will be submitted to ultrasound-guided genicular nerves block. The test block will be performed with 0.25% -1,5 mL bupivacaine on each nerve. Patients who present pain improvement> 50% will undergo neurolysis of genicular nerves with 1,5 mL of 7% phenol in each of the genicular nerves. After the procedure, the patients will be evaluated for 3 months in relation to the intensity of pain at rest and movement and duration of analgesia provided by the intervention, range of movements and functionality of the knee joint.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04024002
        • Recruiting
        • Federal University of São Paulo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signature of the free, informed consent form
  • Age over 18 years old
  • Knee pain for more than six months without improvement with clinical treatment
  • Clinical and imaging diagnosis (radiography) of knee osteoarthritis
  • Moderate pain intensity (pain greater than 4, by the numerical scale).

Exclusion Criteria:

  • Cognitive impairment or psychiatric disease
  • Other causes of knee pain (trauma, complex regional pain syndrome)
  • Puncture site infection
  • Coagulopathy or use of anticoagulant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Phenol
Patients will undergo neurolysis of genicular nerves with 1,5 mL of 7% phenol in each of the genicular nerves (superior, medial and lateral).
Drug: Phenol
1,5 mL of 7% phenol will be injected in each of genicular nerves (superior, medial and lateral).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Pain score
Time Frame: 15 days, 1 month, 2 months and 3 months after the procedure.
Patients will be evaluated before the procedure (baseline) and for 3 months in relation to the intensity of pain at rest and movement . The numeric pain scale from 0 (best condition) to 10 (worst condition) will be used to evaluate the patients.
15 days, 1 month, 2 months and 3 months after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline WOMAC score
Time Frame: 15 days, 1 month, 2 months and 3 months after the procedure
Patients will be evaluated before the procedure (baseline) and for 3 months after the procedure in relation to the WOMAC score. The WOMAC range from 0 (best condition) to 100 ( worst condition).
15 days, 1 month, 2 months and 3 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Chair: Leonardo HC Ferraro, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2018

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Phenol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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