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The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02436434
Recruitment Status : Withdrawn (The effect is poor)
First Posted : May 6, 2015
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Device: pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis
Study Start Date : May 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436434


Locations
Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, Taiwan, 886
Tri-Service General Hospital, National Defense Medical Center,
Taipei, Neihu District, Taiwan, 886
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Publications:
Responsible Party: Yung-Tsan Wu, Attending Physician, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02436434     History of Changes
Other Study ID Numbers: TriServiceGH
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
Pulsed radiofrequency, osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases