Osteoarthritis, Knee, Osteoarthritis, Pain, Chronic
Conditions
Keywords
intra-articular pulsed radiofrequency, knee osteoarthritis, intra-articular steroid injection
Brief summary
The aim of this study is to investigate the additional effect of Intra-articular Pulsed Radiofrequency (IAPRF) on pain and functional activities in addition to intra-articular steroids in patients with grade II and III knee osteoarthritis.
Detailed description
This randomized controlled trial included patients over 18 years of age with knee pain persisting for more than 3 months and stage II-III knee OA according to the Kellgren-Lawrence scale. The participants were randomized into two groups: the IAPRF + steroid injection (Group 1) and only steroid injection (Group 2) groups. The injections were administered under fluoroscopic guidance in both groups, and the needle was advanced to the midline of the tibiofemoral joint in the anteroposterior and lateral views. Group 1 received 8 mg of intra-articular dexamethasone after IAPRF application for 360 s at 45 V voltage, with the temperature not exceeding 42°C. Group 2 received 8 mg of intra-articular dexamethasone only. Pain intensity and participation in daily activities were evaluated using the numerical rating scale (NRS) and Western Ontario and McMaster Universities arthritis index (WOMAC), respectively, before the procedure and 1, 4, and 12 weeks after the procedure.
Interventions
A 22-gauge 10 cm radiofrequency cannula with a 10-mm active tip was advanced to the mid-tibiofemoral joint under fluoroscopic guidance. After needle insertion, paresthesia-pain and motor stimulation tests were performed using sensory (50 Hz) and motor (2 Hz, 1 V) stimulation to confirm the absence of stimulation. Intra-articular Pulsed Radiofrequency (IAPRF) was applied at 45 V voltage for 20 ms pulse width for 360 s, followed by a 480 ms silent phase. The tissue temperature was adjusted to not exceed 42°C.
8 mg dexamethasone was applied into the tibio-femoral joint with a 22-gauge, 10 cm needle under fluoroscopy.
Sponsors
Başakşehir Çam & Sakura City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Procedures and evaluations were performed by different practitioners
Intervention model description
Single-center, single-blinded, randomized prospective trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years, * Having knee pain persisting for more than 3 months due to knee osteoarthritis (OA), * Kellgren-Lawrence Classification grades II and III OA, * Giving written and verbal informed consents.
Exclusion criteria
* Patients with a history of undergoing knee surgery and/or receiving any intra-articular knee injection within the previous 6 months, * Having a local or systemic infection or a coagulation disorder, * Patients who refused to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale | 0, 1, 4 and 12 weeks | Pain levels before and 1, 4, 12 weeks after the procedure were evaluated with Numeric Rating Scale (NRS). The patients were instructed to score their pain intensity on a scale of 0 to 10, where 0 represents no pain at all and 10 represents worst pain ever possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Arthritis Index | 0, 1, 4 and 12 weeks | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to assess daily living activities at all evaluation points.The WOMAC consists of 24 items on three subscales: pain, stiffness, and physical function. All items were scored on a scale of 0 to 4, where 0 represents none, 1 represents mild, 2 represents moderate, 3 represents severe, and 4 represents extreme. The total score ranges from 0 to 96, with a higher score indicating poorer function in daily living activities. |
Countries
Turkey (Türkiye)
Outcome results
None listed