Back to resultsRadiofrequency Ablation in the Pain Management of Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Radio-frequency ablation
Intra-articular steroids
Pulsed Radio-frequency
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- patients diagnosed with KOA based on the American College of Rheumatology criteria
- age 18-70 years
- grade 2 or 3 KOA based on the Kellgren-Lawrence classification
- patients who did not respond to conservative treatment (physiotherapy, oral NSAIDs, and/or intraarticular injections of hyaluronic acid and corticosteroid) for 3 months
- duration of knee pain ≥ 3 months
- numeric rating scale (NRS) ≥ 5 points within 24 h prior to admission.
Exclusion Criteria:
- grade 1 or 4 KOA based on the Kellgren-Lawrence classification
- severe liver, kidney, cardiovascular, and respiratory disease
- abnormal blood coagulation
- skin infections in the puncture region
- patients who previously underwent knee arthroscopy, TKA, RFTGN, or IAPRF
- mental disorders or inability to complete the follow-up observational form
- patients with bilateral knee pain.
Sites / Locations
- Assiut University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
RFT group
IAPRF group
IAS group
Arm Description
The treatment of the patients in the radio frequency thermo-coagulation of the genicular nerves was conducted under the guidance of C-arm X-ray machine . The C-arm machine showed that the radiofrequency cannula needle was advanced percutaneously towards the periosteal areas connecting the shaft of the femur to bilateral epicondyles and the shaft of the tibia to the medial epicondyle while the lateral image showed that the depth of the needle insertion was about 50% of the diameter of the femur or tibia. The radiofrequency electrodes were connected and tested. These induced abnormal pain around the knee joint at 50 Hz and 0.1-0.3 V, but did not induce contraction of the muscles of the knee joint at 2 Hz and > 2.0 V. The location of the needle tip was confirmed by the C-arm, and 0.5 mL of 1% lidocaine was used for local anesthesia. The temperature of RFT was increased gradually to 70°C for 180 seconds.
The puncture site was selected in the middle of the medial or lateral edge of the patella. After local anesthesia was administered with 0.5% lidocaine, the radiofrequency cannula needle was inserted slowly between the patella and femoral condyles. The needle was gradually inserted into the joint cavity, and then a small volume of saline was administered using a syringe. If any resistance was encountered, which indicated that the needle tip was located in a ligament or tendon, the surgeon readjusted the needle tip until the injection proceeded without any significant resistance. After entering the joint cavity, the C-arm x-ray is used confirm that the cannula needle was located in the middle of the joint space. Subsequently, sensory stimulation using 50 Hz/2 Hz was performed at > 2 V, to prevent inducing pain or muscle contraction. Then, an automatic PRF mode ≤ 45 V (≤ 42°C, 2 Hz, pulse width of 20 ms) was administered for 300 seconds.
The puncture procedure was similar to that for the IAPRF group. After the cannula needle was inserted to the articular cavity, 1 mL compound betamethasone (2 mg betamethasone sodium phosphate and 5 mg betamethasone dipropionate) was injected. Then, the needle was withdrawn, and the puncture site was dressed aseptically.
Outcomes
Primary Outcome Measures
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").
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.
Secondary Outcome Measures
Duration of pain free periods
Duration of pain free periods since the intervention has been done
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05303766
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RFT group
Arm Type
Experimental
Arm Description
The treatment of the patients in the radio frequency thermo-coagulation of the genicular nerves was conducted under the guidance of C-arm X-ray machine . The C-arm machine showed that the radiofrequency cannula needle was advanced percutaneously towards the periosteal areas connecting the shaft of the femur to bilateral epicondyles and the shaft of the tibia to the medial epicondyle while the lateral image showed that the depth of the needle insertion was about 50% of the diameter of the femur or tibia. The radiofrequency electrodes were connected and tested. These induced abnormal pain around the knee joint at 50 Hz and 0.1-0.3 V, but did not induce contraction of the muscles of the knee joint at 2 Hz and > 2.0 V. The location of the needle tip was confirmed by the C-arm, and 0.5 mL of 1% lidocaine was used for local anesthesia. The temperature of RFT was increased gradually to 70°C for 180 seconds.
Arm Title
IAPRF group
Arm Type
Experimental
Arm Description
The puncture site was selected in the middle of the medial or lateral edge of the patella. After local anesthesia was administered with 0.5% lidocaine, the radiofrequency cannula needle was inserted slowly between the patella and femoral condyles. The needle was gradually inserted into the joint cavity, and then a small volume of saline was administered using a syringe. If any resistance was encountered, which indicated that the needle tip was located in a ligament or tendon, the surgeon readjusted the needle tip until the injection proceeded without any significant resistance. After entering the joint cavity, the C-arm x-ray is used confirm that the cannula needle was located in the middle of the joint space. Subsequently, sensory stimulation using 50 Hz/2 Hz was performed at > 2 V, to prevent inducing pain or muscle contraction. Then, an automatic PRF mode ≤ 45 V (≤ 42°C, 2 Hz, pulse width of 20 ms) was administered for 300 seconds.
Arm Title
IAS group
Arm Type
Experimental
Arm Description
The puncture procedure was similar to that for the IAPRF group. After the cannula needle was inserted to the articular cavity, 1 mL compound betamethasone (2 mg betamethasone sodium phosphate and 5 mg betamethasone dipropionate) was injected. Then, the needle was withdrawn, and the puncture site was dressed aseptically.
Intervention Type
Device
Intervention Name(s)
Radio-frequency ablation
Other Intervention Name(s)
Radiofrequency generator
Intervention Description
Radiofrequency thermocoagulation of the genicular nerves
Intervention Type
Drug
Intervention Name(s)
Intra-articular steroids
Other Intervention Name(s)
Betafos®
Intervention Description
Intra-articular steroids for Knee osteoarthritis
Intervention Type
Device
Intervention Name(s)
Pulsed Radio-frequency
Other Intervention Name(s)
Radiofrequency generator
Intervention Description
Intraarticular Pulsed Radiofrequency of the knee
Primary Outcome Measure Information:
Title
Numeric rating scale (NRS)
Description
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").
Time Frame
9 months and after procedure
Title
Oxford Knee Score
Description
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.
Time Frame
9 months and after procedure
Secondary Outcome Measure Information:
Title
Duration of pain free periods
Description
Duration of pain free periods since the intervention has been done
Time Frame
9 months and after procedure
Title
Site of pain
Description
Patients undergo physical knee examination to determine the site of knee pain at right or left knee , medial or lateral joint line
Time Frame
9 months and after procedure
Title
Total consumption of analgesics ( e.g NSAIDS , weak opioids… ect )
Description
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.
Time Frame
9 months and after procedure
Title
Improvement of knee joint function
Description
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.
Time Frame
9 months and after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients diagnosed with KOA based on the American College of Rheumatology criteria
age 18-70 years
grade 2 or 3 KOA based on the Kellgren-Lawrence classification
patients who did not respond to conservative treatment (physiotherapy, oral NSAIDs, and/or intraarticular injections of hyaluronic acid and corticosteroid) for 3 months
duration of knee pain ≥ 3 months
numeric rating scale (NRS) ≥ 5 points within 24 h prior to admission.
Exclusion Criteria:
grade 1 or 4 KOA based on the Kellgren-Lawrence classification
severe liver, kidney, cardiovascular, and respiratory disease
abnormal blood coagulation
skin infections in the puncture region
patients who previously underwent knee arthroscopy, TKA, RFTGN, or IAPRF
mental disorders or inability to complete the follow-up observational form
patients with bilateral knee pain.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Golnar Mohamed Fathy
Phone
01009160566
Email
Golnar_fathy@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ola Mahmoud Wahba
Phone
01013046017
Email
Olawahba69@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esraa M Osman, MBBCH
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD to be shared
IPD Sharing Time Frame
Starting in March 2023
IPD Sharing Access Criteria
Open access
Learn more about this trial
Radiofrequency Ablation in the Pain Management of Knee Osteoarthritis
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