chronic knee pain, Osteoarthritis
Conditions
Interventions
All patients in group A and B wil receive a diagnostic nerve block and will be
randomised to either RFA or phenol ablation of genicular nerves.
- Diagnostic blocks will be performed by injection of
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Adult patients of both sexes, older then 35 years who are not a candidate for TKA (total knee arthroplasty) due to young age, old age, comorbidity or technical reasons. 2.OKS under 30 on a scale from 0 (severe function) to 48 points (satisfactory function). 3. Continued pain in the target knee that is moderate to severe (defined as NRS >= 6 on an 11-point NRS scale) either constantly or with motion despite at least 3 months of conservative treatments. Conservative treatment can include: active physiotherapy, pharmacological treatment of pain (acetaminophen or NSAIDs) and intra-articular corticosteroid infiltration. 4. Radiologic confirmation of arthritis for the target knee. Defined as the Kellgren Lawrence (KL) score of 2 or more on X-ray or MRI.
Exclusion criteria
Exclusion criteria: Patient with prior ablation of the genicular nerves, prior partial, resurfacing, or TKA of the target knee (residual hardware). Patient with a history of neurovascular injury or recent trauma of the lower extremities. Patient with chronic widespread pain. Polyneuropathy and/or radicular pain in the lower extremities. Patient is currently implanted with a neurostimulator.Local or systemic infection (bacteraemia).Uncontrolled immune suppression. This means immune suppression leading to symptoms as frequent infections. Intramuscular or intra-articular injection with steroids in the target knee within 42 days from randomisation or intra-articular injections with hyaluronic acid, platelet enriched plasma or stem cells in the target knee within 90 days from randomisation. Arthroscopic debridement/lavage into the target knee within 180 days from randomisation. Allergies to products used during the procedure (lidocaine, phenol, contrast dye).Patients who have a planned TKA in the near future, defined as patients who already have agreed on a date for the TKA procedure.Patients with psychosocial problems as determined by the investigator.Patients who are not able to perform the performance based tests as determined by the investigator. Symptoms of a locked knee. This means obstruction of knee movement, most frequently caused by torn fragments (meniscus tears) that become lodged between the femur and tibia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter, the OKS (Oxford Knee Score) will be collected at baseline, and at 6 weeks, 3 months, 6 months and 12 months after the intervention. The OKS is scored in different ways. We will use the 0 to 48 system which is considered the best. In this system each question is scored between 0 and 4, with 4 being the best outcome. This produces overall scores from 0 to 48, with 48 being the best outcome and a lower score indicates more functional limitations and pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) will be collected just before the genicular nerve ablation, and at 6 weeks, 3 months, 6 months and 12 months follow up. 2. Pain in rest and during the performance based tests will be measured with the NRS. 3. Three Performance based tests • 30 second chair stand test (30-s CST): • 40 meters (4x10m) fast-paced walk test (40-m FPWT): • 9-steps stair-climb test (9-step SCT): 4. The EQ-5D-5L questionnaire. 5. Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS) 6. Catastrophizing measured by the Pain Catastrophizing Scale (PCS) 7. The cut-off value for the diagnostic block 8. The patient satisfaction with the result of treatment will be measured with a 5-point Likert scale (1-5). T 9. The Patient Global Impression of Change (PGIC) in pain and function will be measured with a 5-point Likert scale (1-5). 10. MIC: We will use distribution and anchor based methods to determine the MIC on the patient reported outcomes OKS and performance based tests. For the EQ-5D-5L we will use an instrument defined method. 11.Adverse events: The reported treatment related or probably treatment related adverse events will be listed as numbers with frequencies per treatment. 12. Medication: The patients will be asked to report changes in the use of NSAIDs and opioids during the follow-up visits. The results will be summarised as increased use, no change, decrease in use and use of opioids will be reported as MME (Morphine Milligram Equivalents). 13. The number of TKAs (total knee arthroplasties) during the study follow-up will be documented including the point in time since the intervention. If applicable, we will use the Kaplan-Meier estimator to estimate the survival function. 14. The total procedure time of chemical ablation and RFA will be measured in minutes. The measurement starts as soon as the treating physician puts on his sterile gloves and will end when the sterile draping | — |
Countries
Netherlands
Contacts
Public ContactG.T.M.L Oei
Dijklander Ziekenhuis
Outcome results
None listed