The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis

Study Overview
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Brief Summary
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Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue. In contrast with conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many studies have shown its benefits in pain relief for certain kinds of chronic pain conditions. For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF is difficult and complicated because the supplying nerve of joint is complex or small. Hence, some authors perform intra-articular PRF on the chronic painful joint for example, knee osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and shoulder joint and the excellent long-term effects are reported. The purpose of this study is to investigate the effect of intra-articular PRF in osteoarthritis.

Detailed Description
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Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue. In contrast with conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many studies have shown its benefits in pain relief for certain kinds of chronic pain conditions. For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF is difficult and complicated because the supplying nerve of joint is complex or small. Hence, some authors perform intra-articular PRF on the chronic painful joint for example, knee osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and shoulder joint and the excellent long-term effects are reported. However, the definite effect of intra-articular PRF for osteoarthritis from current published studies are insufficiently proved because of small patient numbers and lack of placebo-controlled design. The purpose of this study is to investigate the effect of intra-articular PRF in osteoarthritis.

Official Title
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The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 30-75 year-old Clear consciousness No receive steroid injection, hyaluronic acid, platelet rich plasma in past 6 months The pain (VAS) more than 4 Symptom duration at least 6 months Exclusion Criteria: Cancer Joint contracture Coagulopathy Pregnancy Status of Pacemaker Inflammation status Operative history of treated joint

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pulsed radiofrequency<br>Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint | Device: pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)<br>* Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint<br>|
| Sham Comparator: Sham pulsed radiofrequency<br>Sham intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in controlled joint | Device: pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)<br>* Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of pain on1st, 2th, 4th, 8th,12th and 16th weeks after treatment. | Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. | Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in severity of symptoms and functional status on1st, 2th, 4th, 8th,12th and 16th weeks after treatment. | Use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment. | Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment. | 
| Change from baseline of range of motion on1st, 2th, 4th, 8th,12th and 16th weeks after treatment. | Use the goniometer to measure the ROM before treatment and multiple time frame after treatment. | Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment. | 
| Change from baseline of strength on 4th, 8th,12th and 16th weeks after treatment. | Use the isokinetic machine to measure the ROM before treatment and multiple time frame after treatment. | Pre-treatment 4th, 8th,12th and 16th weeks after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulsed radiofrequency, osteoarthritis