Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain
NCT ID: NCT05217979
Last Updated: 2023-11-14
Study Results
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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RECRUITING
NA
60 participants
INTERVENTIONAL
2022-04-04
2025-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Transcutaneous pulsed radiofrequency
After signing informed consent, patients assigned to the intervention group by randomization will receive a single treatment with transcutaneous pulsed radiofrequency.
Transcutaneous pulsed radiofrequency
single treatment with transcutaneous pulsed radiofrequency, for a duration of 15 minutes, at a strength of 800 mA.
Sham
After signing informed consent, patients assigned to the sham group by randomization will receive a single treatment with sham, which is indistinguishable from the active treatment. This is achieved by putting the device in demo mode, which gives all the same audiovisual signals as the active mode, but no treatment. Given that the treatment is not felt by patients, this ensures blinding.
Sham
Sham treatment by turning on the device in demo mode. No treatment delivered, but indistinguishable by sound or visual signals or sensations felt by the study participant
Interventions
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Transcutaneous pulsed radiofrequency
single treatment with transcutaneous pulsed radiofrequency, for a duration of 15 minutes, at a strength of 800 mA.
Sham
Sham treatment by turning on the device in demo mode. No treatment delivered, but indistinguishable by sound or visual signals or sensations felt by the study participant
Eligibility Criteria
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Inclusion Criteria
* Hand osteoarthritis according to the ACR criteria
* Hand pain of at least 30mm on a 100mm VAS
* Chronic hand pain
Exclusion Criteria
* Psoriasis
* Seropositivity for rheumatoid factor of anti-CCP antibodies
* No understanding of the Dutch language
* Fibromyalgia (Following the ACR 2011 classification criteria)
* Neurological disorders interfering with pain perception and measurements
* Carpal tunnel syndrome interfering with pain perception and measurements
* History of chemo- and/or radiotherapy
* Spinal surgery or spinal trauma with lasting complaints interfering with pain perception and measurements
* Cognitive impairment or psychiatric conditions interfering with pain perception and measurements
* Pregnancy or breast-feeding
* Eye surgery for glaucoma or keratoconus or other surgery of the cornea in the three preceding months
* Presence of an implantable cardioverter-defibrillator (ICD), neurostimulator or pacemaker
* Metal implants in the hand, arm, shoulder or neck of the side that is to be treated
18 Years
80 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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Margreet Kloppenburg, MD PhD
Professor
Principal Investigators
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Margreet Kloppenburg, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
LUMC
Locations
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Leiden University Medical Centre
Leiden, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P21.101
Identifier Type: -
Identifier Source: org_study_id
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