Clinical trial NCT03973177: Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain
Official title: Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain, Chronic
Keywords: Total knee arthroplasty
Chronic Pain
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Oxford Knee Score
timeFrame: 3 months
Secondary outcomes:
measure: Numeric Rating Scale Score
timeFrame: 3months
measure: Numeric Rating Scale Score
timeFrame: 6 months
measure: Patients Global Impression of Change
timeFrame: 3 Months
measure: Patients Global Impression of Change
timeFrame: 6 Months
measure: Opioid analgesic use at 3 months
timeFrame: 3 months
measure: Opioid analgesic use at 6 months
timeFrame: 6 months
measure: Non-opioid analgesic use at 3 months
timeFrame: 3 Months
measure: Non-opioid analgesic use at 6 months
timeFrame: 6 Months
measure: PROMIS Pain Intensity Short Form 3a
timeFrame: Baseline
measure: PROMIS Pain Intensity Short Form 3a
timeFrame: 3 Months
measure: PROMIS Pain Intensity Short Form 3a
timeFrame: 6 Months
measure: PROMIS Sleep Disturbance Short Form 4a
timeFrame: Baseline
measure: PROMIS Sleep Disturbance Short Form 4a
timeFrame: 3 Months
measure: PROMIS Sleep Disturbance Short Form 4a
timeFrame: 6 Months
measure: PROMIS Pain Interference Short Form 6b
timeFrame: Baseline
measure: PROMIS Pain Interference Short Form 6b
timeFrame: 3 Months
measure: PROMIS Pain Interference Short Form 6b
timeFrame: 6 Months
measure: Oxford Knee Score
timeFrame: Baseline
measure: Oxford Knee Score
timeFrame: 6 Months
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: 3 Month
measure: Hospital Anxiety and Depression Scale
timeFrame: 6 Month
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: David Walega, MD
role: PRINCIPAL_INVESTIGATOR
References:
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