Clinical trial NCT03601533: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Chronic Pain
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from Baseline Pain score
timeFrame: 15 days, 1 month, 2 months and 3 months after the procedure.
Secondary outcomes:
measure: Change from Baseline WOMAC score
timeFrame: 15 days, 1 month, 2 months and 3 months after the procedure
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Leonardo HC Ferraro, PhD
role: STUDY_CHAIR
References:
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.
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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.
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.
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.
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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.
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.