Knee Osteoarthritis
Conditions
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.
Interventions
DEVICERadio-frequency ablation
Radiofrequency thermocoagulation of the genicular nerves
DRUGIntra-articular steroids
Intra-articular steroids for Knee osteoarthritis
DEVICEPulsed Radio-frequency
Intraarticular Pulsed Radiofrequency of the knee
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale (NRS) | 9 months and after procedure | 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 | 9 months and after procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of pain free periods | 9 months and after procedure | Duration of pain free periods since the intervention has been done |
| Site of pain | 9 months and after procedure | 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 ) | 9 months and after procedure | 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 | 9 months and after procedure | 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. |
Countries
Egypt
Contacts
Primary ContactGolnar Mohamed Fathy
Backup ContactOla Mahmoud Wahba
Outcome results
None listed