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

Sponsor
Federal University of São Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT03601533
Collaborator
(none)
15
1
1
4.9
3.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Study of the Efficacy of Ultrasound-guided Genicular Nerve Block With Phenol for the Treatment of Chronic Pain Due to Knee Osteoarthritis
Actual Study Start Date :
Jun 5, 2018
Anticipated Primary Completion Date :
Oct 1, 2018
Anticipated Study Completion Date :
Nov 1, 2018

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Pain score [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.

Secondary Outcome Measures

  1. Change from Baseline WOMAC score [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federal University of Sao Paulo Sao Paulo Brazil 04024002

Sponsors and Collaborators

  • Federal University of São Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leonardo Henrique Cunha Ferraro, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT03601533
Other Study ID Numbers:
  • Phenol
First Posted:
Jul 26, 2018
Last Update Posted:
Jul 26, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2018