Ultrasound-guided Genicular Nerve Block With Phenol for the Treatment of Chronic Pain Due to Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee, Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Phenol
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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.
Sites / Locations
- Federal University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Phenol
Arm Description
Patients will undergo neurolysis of genicular nerves with 1,5 mL of 7% phenol in each of the genicular nerves (superior, medial and lateral).
Outcomes
Primary Outcome Measures
Change from Baseline Pain score
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
Change from Baseline WOMAC score
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).
Full Information
NCT ID
NCT03601533
First Posted
July 12, 2018
Last Updated
July 24, 2018
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03601533
Brief Title
Ultrasound-guided Genicular Nerve Block With Phenol for the Treatment of Chronic Pain Due to Knee Osteoarthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
November 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phenol
Arm Type
Other
Arm Description
Patients will undergo neurolysis of genicular nerves with 1,5 mL of 7% phenol in each of the genicular nerves (superior, medial and lateral).
Intervention Type
Drug
Intervention Name(s)
Phenol
Intervention Description
1,5 mL of 7% phenol will be injected in each of genicular nerves (superior, medial and lateral).
Primary Outcome Measure Information:
Title
Change from Baseline Pain score
Description
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.
Time Frame
15 days, 1 month, 2 months and 3 months after the procedure.
Secondary Outcome Measure Information:
Title
Change from Baseline WOMAC score
Description
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).
Time Frame
15 days, 1 month, 2 months and 3 months after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo HC Ferraro, PhD
Phone
+551155764069
Email
leohcferraro1@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo HC Ferraro, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04024002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo HC Ferraro, PhD
Phone
+551155764069
Email
leohcferraro1@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27822391
Citation
Wong J, Bremer N, Weyker PD, Webb CA. Ultrasound-Guided Genicular Nerve Thermal Radiofrequency Ablation for Chronic Knee Pain. Case Rep Anesthesiol. 2016;2016:8292450. doi: 10.1155/2016/8292450. Epub 2016 Oct 16.
Results Reference
result
PubMed Identifier
21684382
Citation
Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011 Jun 18;377(9783):2115-26. doi: 10.1016/S0140-6736(11)60243-2.
Results Reference
result
PubMed Identifier
21055873
Citation
Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
Results Reference
result
PubMed Identifier
15135143
Citation
Brenner SS, Klotz U, Alscher DM, Mais A, Lauer G, Schweer H, Seyberth HW, Fritz P, Bierbach U. Osteoarthritis of the knee--clinical assessments and inflammatory markers. Osteoarthritis Cartilage. 2004 Jun;12(6):469-75. doi: 10.1016/j.joca.2004.02.011.
Results Reference
result
PubMed Identifier
26431143
Citation
Yasar E, Kesikburun S, Kilic C, Guzelkucuk U, Yazar F, Tan AK. Accuracy of Ultrasound-Guided Genicular Nerve Block: A Cadaveric Study. Pain Physician. 2015 Sep-Oct;18(5):E899-904.
Results Reference
result
PubMed Identifier
23703432
Citation
Gebhardt R, Wu K. Transversus abdominis plane neurolysis with phenol in abdominal wall cancer pain palliation. Pain Physician. 2013 May-Jun;16(3):E325-30.
Results Reference
result
PubMed Identifier
27228515
Citation
Koyyalagunta D, Engle MP, Yu J, Feng L, Novy DM. The Effectiveness of Alcohol Versus Phenol Based Splanchnic Nerve Neurolysis for the Treatment of Intra-Abdominal Cancer Pain. Pain Physician. 2016 May;19(4):281-92.
Results Reference
result
PubMed Identifier
20699159
Citation
Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001. Erratum In: Clin Geriatr Med. 2013 May;29(2):ix.
Results Reference
result
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Ultrasound-guided Genicular Nerve Block With Phenol for the Treatment of Chronic Pain Due to Knee Osteoarthritis
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