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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
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.
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.
Time frame: 3 months
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)
Time frame: 3months
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)
Time frame: 6 months
Patients Global Impression of Change
Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)
Time frame: 3 Months
Patients Global Impression of Change
Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)
Time frame: 6 Months
Opioid analgesic use at 3 months
Opioid analgesic daily use by self reporting .
Time frame: 3 months
Opioid analgesic use at 6 months
Opioid analgesic daily use by self reporting.
Time frame: 6 months
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Non-opioid analgesic use at 3 months
Non opioid analgesic daily use by self reporting.
Time frame: 3 Months
Non-opioid analgesic use at 6 months
Non opioid analgesic daily use by self reporting.
Time frame: 6 Months
PROMIS Pain Intensity Short Form 3a
3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
Time frame: Baseline
PROMIS Pain Intensity Short Form 3a
3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
Time frame: 3 Months
PROMIS Pain Intensity Short Form 3a
3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
Time frame: 6 Months
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)
Time frame: Baseline
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)
Time frame: 3 Months
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)
Time frame: 6 Months
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)
Time frame: Baseline
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)
Time frame: 3 Months
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)
Time frame: 6 Months
Oxford Knee Score
12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.
Time frame: Baseline
Oxford Knee Score
12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.
Time frame: 6 Months
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.
Time frame: Baseline
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.
Time frame: 3 Month
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.
Time frame: 6 Month