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The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis

NCT ID: NCT02436434

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-11-30

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.

Conditions

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Osteoarthritis

Keywords

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Pulsed radiofrequency, osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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pulsed radiofrequency

Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint

Group Type ACTIVE_COMPARATOR

pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)

Intervention Type DEVICE

Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint

Sham pulsed radiofrequency

Sham intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in controlled joint

Group Type SHAM_COMPARATOR

pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)

Intervention Type DEVICE

Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint

Interventions

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pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)

Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint

Intervention Type DEVICE

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yung-Tsan Wu

Attending Physician, Department of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yung-Tsan Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Locations

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Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, Taiwan

Site Status

Tri-Service General Hospital, National Defense Medical Center,

Taipei, Neihu District, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 18211593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25422652 (View on PubMed)

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. Epub 2013 Aug 14.

Reference Type BACKGROUND
PMID: 23942592 (View on PubMed)

Karaman 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.

Reference Type BACKGROUND
PMID: 21872812 (View on PubMed)

Other Identifiers

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TriServiceGH

Identifier Type: -

Identifier Source: org_study_id