Pain, Chronic
Conditions
Keywords
Total knee arthroplasty, Chronic Pain
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.
Interventions
DRUGPhenol 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.
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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patients Global Impression of Change | 3 Months | Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse) |
| Opioid analgesic use at 3 months | 3 months | Opioid analgesic daily use by self reporting . |
| Opioid analgesic use at 6 months | 6 months | Opioid analgesic daily use by self reporting. |
| Non-opioid analgesic use at 3 months | 3 Months | Non opioid analgesic daily use by self reporting. |
| Non-opioid analgesic use at 6 months | 6 Months | Non opioid analgesic daily use by self reporting. |
| Numeric Rating Scale Score | 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) |
| PROMIS Sleep Disturbance Short Form 4a | 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) |
| PROMIS Pain Interference Short Form 6b | 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) |
| Oxford Knee Score | Baseline | 12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living. |
| Hospital Anxiety and Depression Scale | 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. |
| PROMIS Pain Intensity Short Form 3a | Baseline | 3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe) |
Outcome results
None listed