Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain (PROAP)

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: Hand Osteoarthritis

Treatments: Device: Transcutaneous pulsed radiofrequency; Device: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT05217979

P21.101

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Transcutaneous pulsed radiofrequency

Active Comparator group

Description:

After signing informed consent, patients assigned to the intervention group by randomization will receive a single treatment with transcutaneous pulsed radiofrequency.

Treatment:

Device: Transcutaneous pulsed radiofrequency

Sham

Sham Comparator group

Description:

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.

Treatment:

Device: Sham