Clinical trial NCT05217979: Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain
Official title: Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Osteoarthritis
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Hand pain at 6 weeks after trancutaneous pulsed radiofrequency or sham
timeFrame: 6 weeks
Secondary outcomes:
measure: Hand pain at 12 weeks after trancutaneous pulsed radiofrequency or sham
timeFrame: 12 weeks
measure: Efficacy of transcutaneous pulsed radiofrequency on hand function
timeFrame: 6 weeks, 12 weeks
measure: Efficacy of transcutaneous pulsed radiofrequency on hand stiffness
timeFrame: 6 weeks, 12 weeks
measure: Efficacy of transcutaneous pulsed radiofrequency on the number of tender joints
timeFrame: 6 weeks, 12 weeks
measure: Efficacy of trancutaneous pulsed radiofrequency on anxiety
timeFrame: 6 weeks, 12 weeks
measure: Efficacy of trancutaneous pulsed radiofrequency on depression
timeFrame: 6 weeks, 12 weeks
measure: Global perceived effect of recovery due to trancutaneous pulsed radiofrequency
timeFrame: 6 weeks, 12 weeks
measure: Global perceived effect of satisfaction with trancutaneous pulsed radiofrequency
timeFrame: 6 weeks, 12 weeks
measure: Effect of transcutaneous pulsed radiofrequency therapy on health related quality of life
timeFrame: 6 weeks, 12 weeks
measure: Effect of transcutaneous pulsed radiofrequency therapy on temporal summation assessed using a 256 mN PinPrick
timeFrame: 6 weeks
measure: Effect of transcutaneous pulsed radiofrequency therapy on numbness of the hand.
timeFrame: 6 weeks
measure: Effect of transcutaneous pulsed radiofrequency therapy on allodynia
timeFrame: 6 weeks
measure: Effect of transcutaneous pulsed radiofrequency therapy on PainDETECT scores
timeFrame: 6 weeks, 12 weeks
measure: Effect of transcutaneous pulsed radiofrequency therapy on Michigan Hand Outcome Questionnaire
timeFrame: 6 weeks, 12 weeks
measure: Effect of transcutaneous pulsed radiofrequency therapy on AUSCAN pain scores
timeFrame: 6 weeks, 12 weeks
measure: Effect of transcutaneous pulsed radiofrequency therapy on central sensitization index scores
timeFrame: 6 weeks, 12 weeks
Other outcomes:
measure: Effect of local inflammation at baseline on the efficacy of tPRF
timeFrame: 6 weeks, 12 weeks
measure: Effect of different QST profiles on tPRF efficacy
timeFrame: 6 weeks, 12 weeks
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
state: Zuid-Holland
Study officials:
affiliation: LUMC
name: Margreet Kloppenburg, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: