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The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Pulsed radiofrequency, osteoarthritis

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
  • Tri-Service General Hospital, National Defense Medical Center,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

pulsed radiofrequency

Sham pulsed radiofrequency

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 1, 2015
Last Updated
November 30, 2016
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02436434
Brief Title
The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis
Official Title
The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The effect is poor
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Pulsed radiofrequency, osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pulsed radiofrequency
Arm Type
Active Comparator
Arm Description
Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint
Arm Title
Sham pulsed radiofrequency
Arm Type
Sham Comparator
Arm Description
Sham intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in controlled joint
Intervention Type
Device
Intervention Name(s)
pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)
Intervention Description
Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint
Primary Outcome Measure Information:
Title
Change from baseline of pain on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
Description
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
Secondary Outcome Measure Information:
Title
Change from baseline in severity of symptoms and functional status on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
Description
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.
Time Frame
Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
Title
Change from baseline of range of motion on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
Description
Use the goniometer to measure the ROM before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
Title
Change from baseline of strength on 4th, 8th,12th and 16th weeks after treatment.
Description
Use the isokinetic machine to measure the ROM before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment 4th, 8th,12th and 16th weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan
Facility Name
Tri-Service General Hospital, National Defense Medical Center,
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18211593
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. No abstract available.
Results Reference
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PubMed Identifier
25422652
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.
Results Reference
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PubMed Identifier
23942592
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. Epub 2013 Aug 14.
Results Reference
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PubMed Identifier
21872812
Citation
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.
Results Reference
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The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis

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