Study Stopped
The effect is poor
The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
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Started May 2015
2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedDecember 1, 2016
November 1, 2016
1.5 years
May 1, 2015
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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.
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.
Change from baseline of strength on 4th, 8th,12th and 16th weeks after treatment.
Pre-treatment 4th, 8th,12th and 16th weeks after treatment.
Study Arms (2)
pulsed radiofrequency
ACTIVE COMPARATORIntra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint
Sham pulsed radiofrequency
SHAM COMPARATORSham intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in controlled joint
Interventions
Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cancer
- Joint contracture
- Coagulopathy
- Pregnancy
- Status of Pacemaker
- Inflammation status
- Operative history of treated joint
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 886, Taiwan
Tri-Service General Hospital, National Defense Medical Center,
Taipei, Neihu District, 886, Taiwan
Related Publications (4)
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. No abstract available.
PMID: 18211593BACKGROUNDRahimzadeh 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.
PMID: 25422652BACKGROUNDMasala 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. Epub 2013 Aug 14.
PMID: 23942592BACKGROUNDKaraman H, Tufek A, Kavak GO, 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. Epub 2011 Jul 23.
PMID: 21872812BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yung-Tsan Wu, MD
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician, Department of Physical Medicine and Rehabilitation
Study Record Dates
First Submitted
May 1, 2015
First Posted
May 6, 2015
Study Start
May 1, 2015
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
December 1, 2016
Record last verified: 2016-11