Pulsed radiofrequency therapy for hand osteoarthritis pain
This study is testing whether a new type of pain treatment using pulsed radiofrequency can help people aged 18 to 80 with chronic hand pain from osteoarthritis feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, Zuid-Holland) |
| Trial ID | NCT05217979 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of transcutaneous pulsed radiofrequency therapy in treating pain associated with hand osteoarthritis. Patients aged 18-80 with chronic hand pain will be randomly assigned to receive either the active treatment or a sham procedure. The primary outcome will be measured using a 10-point numeric rating scale for pain over a period of six weeks. The intervention is designed to be low-risk and well-tolerated by participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with chronic hand pain due to osteoarthritis.
Not a fit: Patients with inflammatory rheumatic diseases or other conditions affecting pain perception may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve the quality of life for patients suffering from hand osteoarthritis.
How similar studies have performed: While the approach of using pulsed radiofrequency therapy is relatively novel for this condition, similar studies have shown promise in other pain management contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leiden, Zuid-Holland
- Leiden University Medical Centre — Leiden, Zuid-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Margreet Kloppenburg, Prof. Dr. — Lumc
- Study coordinator: Margreet Kloppenburg, Prof. Dr.
- Email: g.kloppenburg@lumc.nl
- Phone: +31(0)715263423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.