Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain

NCT03973177 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: STU00209591
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic knee pain from osteoarthritis (OA) is commonly treated with total knee arthroplasty (TKA) when conservative therapies fail to provide pain relief. More than 600,000 TKAs are performed in the U.S. annually, a number that continues to increase. A logistic-regression model suggests that the incidence rate of TKA will increase by 143% in the United States by 2050 compared to 2012. Although TKA is successful in reducing knee pain and joint stiffness in most cases, it can be associated with a 7-35% incidence of persistent refractory post-surgical knee pain. Aim: To determine whether chemical neurolysis of the genicular nerves with 6% aqueous phenol is non-inferior in reducing knee pain as compared to corticosteroid injection of the genicular nerves, in patients with refractory chronic knee pain for more than 6 months after total knee replacement. Hypothesis: Chemical neurolysis of genicular nerves with phenol will provide equal or superior pain relief than corticosteroid genicular nerve injections at 3 months, as measured by the Oxford Knee Score.

Conditions

Pain, Chronic

Keywords

Total knee arthroplasty; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Oxford Knee Score

  Oxford Knee Score is a tool which measures 6 post operative items (pain,flexion contracture, extension lag, total range of flexion, alignment of varus and valgus,stability (antero-posterior and mediolateral). The scoring is: below 60 is poor, scoring 60-69 fair, scoring 70-79 good, 80-100 excellent.

  3 months

Secondary Outcomes (22)

• Numeric Rating Scale Score

  3months

• Numeric Rating Scale Score

  6 months

• Patients Global Impression of Change

  3 Months

• Patients Global Impression of Change

  6 Months

• Opioid analgesic use at 3 months

  3 months

Study Arms (2)

Treatment Group: Phenol injection

EXPERIMENTAL

6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target sites

Drug: Phenol Injection

Control Group: Methylprednisolone injection

OTHER

Methylprednisolone acetate 10 mg with 2 mL preservative free saline and 0.5 mL iopamidol 300 will be injected at each of the target site

Drug: Methylprednisolone Injection

Interventions

Phenol Injection DRUG

6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target site with live, pulsed fluoroscopy (5-8 seconds at each location) to observe the contrast dye-tagged phenol covering the lateral margin of the femur or tibia respectively on AP and lateral views. The needles will then be removed and band-aids placed.

Also known as: Phenol

Treatment Group: Phenol injection

Methylprednisolone Injection DRUG

Methylprednisolone acetate 10 mg with 2 mL preservative saline and 0.5 mL iopamidol 300 will be injected at each of the 3 target sites with live, pulsed fluoroscopy (5-8 seconds at each location) to observe the contrast dye-tagged steroid mixture covering the lateral margin of the femur or tibia respectively on AP and lateral views; the needles will be removed and band-aids placed.

Also known as: Methylprednisolone acetate

Control Group: Methylprednisolone injection

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 40-95 years
• Patients with knee pain, on average \> 4 (NRS) persisting more than 6 months after TKA
• Willingness to undergo image guided diagnostic nerve block and the study intervention

You may not qualify if:

• Pain score (NRS) \< 4 at time of study enrollment
• Conditions that preclude the diagnostic block or the study intervention (e.g., irreversible coagulopathy or bleeding disorder, allergic reaction/contraindication to local anesthetic, contrast dye, steroids, and/or phenol, pregnancy, severe or uncontrolled medical illness).
• Evidence of indolent infection of the knee prosthesis (elevated C-reactive protein assessed when clinically indicated)
• Inability to write, speak, or read in English
• Pregnancy

Sponsors & Collaborators

• Northwestern University: lead

Related Publications (15)

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• Drosos GI, Triantafilidou T, Ververidis A, Agelopoulou C, Vogiatzaki T, Kazakos K. Persistent post-surgical pain and neuropathic pain after total knee replacement. World J Orthop. 2015 Aug 18;6(7):528-36. doi: 10.5312/wjo.v6.i7.528. eCollection 2015 Aug 18.

  PMID: 26301182 BACKGROUND

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  PMID: 18627367 BACKGROUND

• Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected increase in total knee arthroplasty in the United States - an alternative projection model. Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803. doi: 10.1016/j.joca.2017.07.022. Epub 2017 Aug 8.

  PMID: 28801208 BACKGROUND

• Sylvester LN, Goree JH. Genicular Radiofrequency Ablation for Treatment of Post Total Knee Arthroplasty Posterior Thigh Pain: A Case Report. A A Case Rep. 2017 Nov 15;9(10):292-293. doi: 10.1213/XAA.0000000000000596.

  PMID: 28697032 BACKGROUND

• Qudsi-Sinclair S, Borras-Rubio E, Abellan-Guillen JF, Padilla Del Rey ML, Ruiz-Merino G. A Comparison of Genicular Nerve Treatment Using Either Radiofrequency or Analgesic Block with Corticosteroid for Pain after a Total Knee Arthroplasty: A Double-Blind, Randomized Clinical Study. Pain Pract. 2017 Jun;17(5):578-588. doi: 10.1111/papr.12481. Epub 2016 Sep 19.

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• Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014 Apr;6(4):373-6. doi: 10.1016/j.pmrj.2013.10.003. Epub 2013 Dec 27.

  PMID: 24373908 BACKGROUND

• Walega DR, McCormick ZL. Chemical Neurolysis of the Genicular Nerves for Chronic Knee Pain: Reviving an Old Dog and an Old Trick. Pain Med. 2018 Sep 1;19(9):1882-1884. doi: 10.1093/pm/pny023. No abstract available.

  PMID: 29514315 BACKGROUND

• 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.

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  PMID: 17151902 BACKGROUND

• Kirazli Y, On AY, Kismali B, Aksit R. Comparison of phenol block and botulinus toxin type A in the treatment of spastic foot after stroke: a randomized, double-blind trial. Am J Phys Med Rehabil. 1998 Nov-Dec;77(6):510-5. doi: 10.1097/00002060-199811000-00012.

  PMID: 9862538 BACKGROUND

• Ahmed A, Arora D, Kochhar AK. Ultrasound-guided alcohol neurolysis of lateral femoral cutaneous nerve for intractable meralgia paresthetica: a case series. Br J Pain. 2016 Nov;10(4):232-237. doi: 10.1177/2049463716668811. Epub 2016 Sep 16.

  PMID: 27867513 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Phenol; Methylprednisolone; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• David Walega, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Pilot Prospective, Randomized, Crossover Trial. (Block randomization scheme with 2:1 allocation (phenol neurolysis : perineural steroid injection) The crossover will occur in subjects who received the steroid injection who did not achieve adequate pain relief at 3 months.

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 4, 2019
• Study Start: May 24, 2019
• Primary Completion: July 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share