The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis
- Conditions
- Osteoarthritis
- Interventions
- Device: pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)
- Registration Number
- NCT02436434
- Lead Sponsor
- Tri-Service General Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Cancer
- Joint contracture
- Coagulopathy
- Pregnancy
- Status of Pacemaker
- Inflammation status
- Operative history of treated joint
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham pulsed radiofrequency pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) Sham intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in controlled joint pulsed radiofrequency pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint
- Primary Outcome Measures
Name Time Method Change from baseline of pain on1st, 2th, 4th, 8th,12th and 16th weeks after treatment. Pre-treatment, 1st, 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.
- Secondary Outcome Measures
Name Time Method Change from baseline of range of motion on1st, 2th, 4th, 8th,12th and 16th weeks after treatment. Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment. Use the goniometer to measure the ROM before treatment and multiple time frame after treatment.
Change from baseline in severity of symptoms and functional status on1st, 2th, 4th, 8th,12th and 16th weeks after treatment. Pre-treatment, 1st, 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.
Change from baseline of strength on 4th, 8th,12th and 16th weeks after treatment. Pre-treatment 4th, 8th,12th and 16th weeks after treatment. Use the isokinetic machine to measure the ROM before treatment and multiple time frame after treatment.
Trial Locations
- Locations (2)
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
🇨🇳Taipei, Neihu District, Taiwan
Tri-Service General Hospital, National Defense Medical Center,
🇨🇳Taipei, Neihu District, Taiwan