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Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03973177
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
David Walega, 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.


Condition or disease Intervention/treatment Phase
Pain, Chronic Drug: Phenol Injection Drug: Methylprednisolone Injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial
Actual Study Start Date : May 24, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Treatment Group: 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
Drug: Phenol Injection
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.
Other Name: Phenol

Control Group: 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
Drug: Methylprednisolone Injection
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.
Other Name: Methylprednisolone acetate




Primary Outcome Measures :
  1. Oxford Knee Score [ Time Frame: 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 :
  1. Numeric Rating Scale Score [ Time Frame: 3months ]
    The proportion of subjects who have > 50% reduction in pain based on the Numeric Rating Scale at 3 months. The NRS is a scale of 0 (no pain) to 10 (worst pain imaginable)

  2. Numeric Rating Scale Score [ Time Frame: 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)

  3. Patients Global Impression of Change [ Time Frame: 3 Months ]
    Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)

  4. Patients Global Impression of Change [ Time Frame: 6 Months ]
    Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)

  5. Opioid analgesic use at 3 months [ Time Frame: 3 months ]
    Opioid analgesic daily use by self reporting .

  6. Opioid analgesic use at 6 months [ Time Frame: 6 months ]
    Opioid analgesic daily use by self reporting.

  7. Non-opioid analgesic use at 3 months [ Time Frame: 3 Months ]
    Non opioid analgesic daily use by self reporting.

  8. Non-opioid analgesic use at 6 months [ Time Frame: 6 Months ]
    Non opioid analgesic daily use by self reporting.

  9. PROMIS Pain Intensity Short Form 3a [ Time Frame: Baseline ]
    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)

  10. PROMIS Pain Intensity Short Form 3a [ Time Frame: 3 Months ]
    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)

  11. PROMIS Pain Intensity Short Form 3a [ Time Frame: 6 Months ]
    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)

  12. PROMIS Sleep Disturbance Short Form 4a [ Time Frame: Baseline ]
    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)

  13. PROMIS Sleep Disturbance Short Form 4a [ Time Frame: 3 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)

  14. PROMIS Sleep Disturbance Short Form 4a [ Time Frame: 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)

  15. PROMIS Pain Interference Short Form 6b [ Time Frame: Baseline ]
    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)

  16. PROMIS Pain Interference Short Form 6b [ Time Frame: 3 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)

  17. PROMIS Pain Interference Short Form 6b [ Time Frame: 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)

  18. Oxford Knee Score [ Time Frame: Baseline ]
    12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.

  19. Oxford Knee Score [ Time Frame: 6 Months ]
    12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.

  20. Hospital Anxiety and Depression Scale [ Time Frame: Baseline ]
    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.

  21. Hospital Anxiety and Depression Scale [ Time Frame: 3 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.

  22. Hospital Anxiety and Depression Scale [ Time Frame: 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.



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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973177


Contacts
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Contact: David Walega, MD 312-695-2500 d-walega@northwestern.edu

Locations
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United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: David Walega, MD    312-695-2500    d-walega@northwestern.edu   
Principal Investigator: David Walega, MD         
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: David Walega, MD Northwestern University
Publications:

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Responsible Party: David Walega, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT03973177    
Other Study ID Numbers: STU00209591
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by David Walega, Northwestern University:
Total knee arthroplasty
Chronic Pain
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Phenol
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Sclerosing Solutions
Pharmaceutical Solutions