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Clinical Trials/NCT02436434
NCT02436434
Withdrawn
Not Applicable

The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis

Tri-Service General Hospital2 sites in 1 countryMay 2015
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Tri-Service General Hospital
Locations
2
Primary Endpoint
Change from baseline of pain on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
Status
Withdrawn
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
November 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yung-Tsan Wu

Attending Physician, Department of Physical Medicine and Rehabilitation

Tri-Service General Hospital

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

  • Joint contracture
  • Coagulopathy
  • Pregnancy
  • Status of Pacemaker
  • Inflammation status
  • Operative history of treated joint

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 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 strength on 4th, 8th,12th and 16th weeks after treatment.(Pre-treatment 4th, 8th,12th and 16th weeks after treatment.)

Study Sites (2)

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