Clinical trial NCT05303766: Radiofrequency Ablation in the Pain Management of Knee Osteoarthritis
Official title: Comparing the Safety and Effectiveness of Radiofrequency Thermocoagulation on Genicular Nerve, Intraarticular Pulsed Radiofrequency With Steroid Injection in the Pain Management of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the safety and efficacy of radio frequency thermo-coagulation on the genicular nerve (RFTGN) and intra-articular pulsed radio frequency (IAPRF) for Knee Osteoarthritis (KOA) to improve physical activity , range of joint movement , pain intensity and quality of life.

Detailed description: After obtaining the consent from patients and being informed about the study and potential risks , all patients were randomly assigned to the RFTGN, IAPRF, and intraarticular steroid injection (IAS) groups. All procedures were performed under the guidance of C-arm X-ray machine. The observation indicators of this study were the numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE). The time points for the assessment were 1-week, 1-month, 3-months, 6-months and 9-months after the treatment.

Eligibility criteria: * Inclusion Criteria:

  1. patients diagnosed with KOA based on the American College of Rheumatology criteria
  2. age 18-70 years
  3. grade 2 or 3 KOA based on the Kellgren-Lawrence classification
  4. patients who did not respond to conservative treatment (physiotherapy, oral NSAIDs, and/or intraarticular injections of hyaluronic acid and corticosteroid) for 3 months
  5. duration of knee pain ≥ 3 months
  6. numeric rating scale (NRS) ≥ 5 points within 24 h prior to admission.
* Exclusion Criteria:

  1. grade 1 or 4 KOA based on the Kellgren-Lawrence classification
  2. severe liver, kidney, cardiovascular, and respiratory disease
  3. abnormal blood coagulation
  4. skin infections in the puncture region
  5. patients who previously underwent knee arthroscopy, TKA, RFTGN, or IAPRF
  6. mental disorders or inability to complete the follow-up observational form
  7. patients with bilateral knee pain.

Primary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: 9 months and after procedure
measure: Oxford Knee Score
timeFrame: 9 months and after procedure
Secondary outcomes:
measure: Duration of pain free periods
timeFrame: 9 months and after procedure
measure: Site of pain
timeFrame: 9 months and after procedure
measure: Total consumption of analgesics ( e.g NSAIDS , weak opioids… ect )
timeFrame: 9 months and after procedure
measure: Improvement of knee joint function
timeFrame: 9 months and after procedure
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Esraa M Osman, MBBCH
role: PRINCIPAL_INVESTIGATOR
References: