Radiofrequency Ablation in the Pain Management of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05303766
• Other study ID #: Radiofrequency Ablation KOA
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: March 2023

Study information

• Verified date: April 2022
• Source: Assiut University
• Contact: Golnar Mohamed Fathy
• Phone: 01009160566
• Email: Golnar_fathy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Radio-frequency ablation
Radiofrequency thermocoagulation of the genicular nerves

Drug:
• Intra-articular steroids
Intra-articular steroids for Knee osteoarthritis

Device:
• Pulsed Radio-frequency
Intraarticular Pulsed Radiofrequency of the knee

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rating scale (NRS)	Using the numerical rating score , a score from ( 0 to 10 ) for evaluation of pain intensity. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	9 months and after procedure
Primary	Oxford Knee Score	Using oxford knee score for follow up of pain of knee osteoarthritis , a score from 0 to 48 . if the score is 0 to 19 this may indicate sever arthritis , and if it's from 40 to 48 it means satisfactory joint function . This scrore is based on a 12-question report about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks.	9 months and after procedure
Secondary	Duration of pain free periods	Duration of pain free periods since the intervention has been done	9 months and after procedure
Secondary	Site of pain	Patients undergo physical knee examination to determine the site of knee pain at right or left knee , medial or lateral joint line	9 months and after procedure
Secondary	Total consumption of analgesics ( e.g NSAIDS , weak opioids… ect )	Different analgesics used by the patients to alleviate the pain. The patient is asked about how frequent he/she uses an analgesic for pain relief.	9 months and after procedure
Secondary	Improvement of knee joint function	Using The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for evaluation of knee osteoarthritis. t is a self-administered questionnaire consisting of 24 items divided into 3 subscales: 1- Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright.; 2-Stiffness (2 items): after first waking and later in the day. 3- Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.	9 months and after procedure