Osteoarthritis Clinical Trial
Official title:
The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis
Verified date | November 2016 |
Source | Tri-Service General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Ministry of Health and Welfare |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | 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 |
Lead Sponsor | Collaborator |
---|---|
Tri-Service General Hospital |
Taiwan,
Karaman H, Tüfek A, Kavak GÖ, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. — View Citation
Masala S, Fiori R, Raguso M, Morini M, Calabria E, Simonetti G. Pulse-dose radiofrequency for knee osteoartrithis. Cardiovasc Intervent Radiol. 2014 Apr;37(2):482-7. doi: 10.1007/s00270-013-0694-z. — View Citation
Rahimzadeh P, Imani F, Faiz SH, Entezary SR, Nasiri AA, Ziaeefard M. Investigation the efficacy of intra-articular prolotherapy with erythropoietin and dextrose and intra-articular pulsed radiofrequency on pain level reduction and range of motion improvement in primary osteoarthritis of knee. J Res Med Sci. 2014 Aug;19(8):696-702. — View Citation
Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Yes |
Secondary | 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. | Yes |
Secondary | 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. | Yes |
Secondary | 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. | Yes |
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