Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain
Primary Purpose
Pain, Chronic
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Phenol Injection
Methylprednisolone Injection
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic focused on measuring Total knee arthroplasty, Chronic Pain
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment Group: Phenol injection
Control Group: Methylprednisolone injection
Arm Description
6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target sites
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Numeric Rating Scale Score
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)
Numeric Rating Scale Score
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)
Patients Global Impression of Change
Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)
Patients Global Impression of Change
Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)
Opioid analgesic use at 3 months
Opioid analgesic daily use by self reporting .
Opioid analgesic use at 6 months
Opioid analgesic daily use by self reporting.
Non-opioid analgesic use at 3 months
Non opioid analgesic daily use by self reporting.
Non-opioid analgesic use at 6 months
Non opioid analgesic daily use by self reporting.
PROMIS Pain Intensity Short Form 3a
3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
PROMIS Pain Intensity Short Form 3a
3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
PROMIS Pain Intensity Short Form 3a
3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
PROMIS Sleep Disturbance Short Form 4a
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)
PROMIS Sleep Disturbance Short Form 4a
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)
PROMIS Sleep Disturbance Short Form 4a
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)
PROMIS Pain Interference Short Form 6b
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)
PROMIS Pain Interference Short Form 6b
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)
PROMIS Pain Interference Short Form 6b
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)
Oxford Knee Score
12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.
Oxford Knee Score
12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.
Hospital Anxiety and Depression Scale
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.
Hospital Anxiety and Depression Scale
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.
Hospital Anxiety and Depression Scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03973177
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Covid restrictions on recruitment
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
Total knee arthroplasty, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group: Phenol injection
Arm Type
Experimental
Arm Description
6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target sites
Arm Title
Control Group: Methylprednisolone injection
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Phenol Injection
Other Intervention Name(s)
Phenol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Injection
Other Intervention Name(s)
Methylprednisolone acetate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxford Knee Score
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Numeric Rating Scale Score
Description
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)
Time Frame
3months
Title
Numeric Rating Scale Score
Description
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)
Time Frame
6 months
Title
Patients Global Impression of Change
Description
Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)
Time Frame
3 Months
Title
Patients Global Impression of Change
Description
Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)
Time Frame
6 Months
Title
Opioid analgesic use at 3 months
Description
Opioid analgesic daily use by self reporting .
Time Frame
3 months
Title
Opioid analgesic use at 6 months
Description
Opioid analgesic daily use by self reporting.
Time Frame
6 months
Title
Non-opioid analgesic use at 3 months
Description
Non opioid analgesic daily use by self reporting.
Time Frame
3 Months
Title
Non-opioid analgesic use at 6 months
Description
Non opioid analgesic daily use by self reporting.
Time Frame
6 Months
Title
PROMIS Pain Intensity Short Form 3a
Description
3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
Time Frame
Baseline
Title
PROMIS Pain Intensity Short Form 3a
Description
3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
Time Frame
3 Months
Title
PROMIS Pain Intensity Short Form 3a
Description
3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
Time Frame
6 Months
Title
PROMIS Sleep Disturbance Short Form 4a
Description
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)
Time Frame
Baseline
Title
PROMIS Sleep Disturbance Short Form 4a
Description
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)
Time Frame
3 Months
Title
PROMIS Sleep Disturbance Short Form 4a
Description
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)
Time Frame
6 Months
Title
PROMIS Pain Interference Short Form 6b
Description
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)
Time Frame
Baseline
Title
PROMIS Pain Interference Short Form 6b
Description
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)
Time Frame
3 Months
Title
PROMIS Pain Interference Short Form 6b
Description
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)
Time Frame
6 Months
Title
Oxford Knee Score
Description
12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.
Time Frame
Baseline
Title
Oxford Knee Score
Description
12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.
Time Frame
6 Months
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Baseline
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
3 Month
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
6 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Walega, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain
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