The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis

November 30, 2016 updated by: Yung-Tsan Wu, Tri-Service General Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Neihu District
      • Taipei, Neihu District, Taiwan, 886
        • Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
      • Taipei, Neihu District, Taiwan, 886
        • Tri-Service General Hospital, National Defense Medical Center,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pulsed radiofrequency
Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint
Device: pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)
Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint
Sham Comparator: Sham pulsed radiofrequency
Sham intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in controlled joint
Device: pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)
Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of pain on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
Time Frame: 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.
Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in severity of symptoms and functional status on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
Pre-treatment 4th, 8th,12th and 16th weeks after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 1, 2015

First Submitted That Met QC Criteria

May 1, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TriServiceGH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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