Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain

NCT ID: NCT05217979

Last Updated: 2023-11-14

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2025-02-01

Brief Summary

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Different types of pain may be present in patients with hand osteoarthritis, including nociceptive pain and non-nociceptive pain. This makes adequate pain treatment difficult, and thus new treatment options are needed. To this end, this trial will evaluate the effect of transcutaneous pulsed radiofrequency for the treatment of hand osteoarthritis pain.

Detailed Description

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In this randomized clinical trial, patients with hand osteoarthritis, recruited from the Leiden University Medical Center Rheumatology outpatient clinic, aged 18-80 and fulfilling hand pain criteria will be randomized to undergo trancutaneous pulsed radiofrequency therapy of the hand or a sham. The effect will be measured in change in 10 point numeric rating scale for pain in the hand over 6 weeks. This RCT will have little burdens and risk for the subjects. The proposed intervention, tPRF, is well tolerated, with no known serious side effects.

Conditions

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Hand Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

Transcutaneous pulsed radiofrequency

Intervention Type DEVICE

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.

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

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.

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18-80
* Hand osteoarthritis according to the ACR criteria
* Hand pain of at least 30mm on a 100mm VAS
* Chronic hand pain

Exclusion Criteria

* Known inflammatory rheumatic diseases
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Margreet Kloppenburg, MD PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Margreet Kloppenburg, Prof. Dr.

Role: CONTACT

+31(0)715263423

Miranda Van Lunteren, Dr

Role: CONTACT

+31(0)715263592

Facility Contacts

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Margreet Kloppenburg, Prof. Dr.

Role: primary

+31715263423

Other Identifiers

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P21.101

Identifier Type: -

Identifier Source: org_study_id

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