Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain

Phase 4

Withdrawn

• Conditions: Pain, Chronic
• Interventions: Drug: Phenol Injection; Drug: Methylprednisolone Injection

• Registration Number: NCT03973177
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2019-05-24
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-28
• Primary Completion: 2022-07
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Group: Phenol injection	Phenol Injection	6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target sites
Control Group: Methylprednisolone injection	Methylprednisolone Injection	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

Primary Outcome Measures

Name	Time	Method
Oxford Knee Score	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Opioid analgesic use at 3 months	3 months	Opioid analgesic daily use by self reporting .
PROMIS Sleep Disturbance Short Form 4a	6 Months	4 question sleep survey. First section is quality of sleep rated on a 5 response (very poor)- (very good) scale.Section rating quality of sleep based on 5 response choices (not at all) to (very much)
Numeric Rating Scale Score	6 months	The proportion of subjects who have \> 50% reduction in pain based on the Numeric Rating Scale at 6 months. The NRS is a scale of 0 (no pain) to 10 (worst pain imaginable)
Non-opioid analgesic use at 3 months	3 Months	Non opioid analgesic daily use by self reporting.
Oxford Knee Score	6 Months	12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.
Hospital Anxiety and Depression Scale	6 Month	Hospital Anxiety and Depression Scale (HADS) is a 14 question survey (7 anxiety and 7 depression) questions answered on a 0 (low) - 3 (high) scale. Total score of 0-7 is normal, 8-10 is baseline abnormal and a score between 11-21 is abnormal.
Opioid analgesic use at 6 months	6 months	Opioid analgesic daily use by self reporting.
Non-opioid analgesic use at 6 months	6 Months	Non opioid analgesic daily use by self reporting.
PROMIS Pain Interference Short Form 6b	6 Months	6 question pain survey. First section is interference of pain rated on a 5 response (not at all)- (very much) scale. Section is one socialization question with 5 response choices (never)- (always)
Patients Global Impression of Change	6 Months	Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)
PROMIS Pain Intensity Short Form 3a	6 Months	3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)