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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03601533
• Other study ID #: Phenol
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: July 2018
• Source: Federal University of São Paulo
• Contact: Leonardo HC Ferraro, PhD
• Phone: +551155764069
• Email: leohcferraro1[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Phenol
1,5 mL of 7% phenol will be injected in each of genicular nerves (superior, medial and lateral).

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. Review. — View 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. — View 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):481-7. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4. — View 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. — View 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. — View 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. Epub 2016 Oct 16. — View Citation

Yasar E, Kesikburun S, Kiliç C, Güzelküçük Ü, Yazar F, Tan AK. Accuracy of Ultrasound-Guided Genicular Nerve Block: A Cadaveric Study. Pain Physician. 2015 Sep-Oct;18(5):E899-904. — View 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. Review. Erratum in: Clin Geriatr Med. 2013 May;29(2):ix. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 days, 1 month, 2 months and 3 months after the procedure.
Secondary	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).	15 days, 1 month, 2 months and 3 months after the procedure