Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain (PROAP)

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.

Study Overview

• Status: Recruiting
• Conditions: Hand Osteoarthritis
• Intervention / Treatment: Device: Transcutaneous pulsed radiofrequency; Device: Sham

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margreet Kloppenburg, Prof. Dr.; Phone Number: +31(0)715263423; Email: g.kloppenburg@lumc.nl
• Study Contact Backup: Name: Miranda Van Lunteren, Dr; Phone Number: +31(0)715263592; Email: onderzoekcoreum@lumc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Recruiting
      • Leiden University Medical Centre
      • Contact: Margreet Kloppenburg, Prof. Dr.; Phone Number: +31715263423; Email: g.kloppenburg@lumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transcutaneous pulsed radiofrequency; After signing informed consent, patients assigned to the intervention group by randomization will receive a single treatment with transcutaneous pulsed radiofrequency.	Device: Transcutaneous pulsed radiofrequency; single treatment with transcutaneous pulsed radiofrequency, for a duration of 15 minutes, at a strength of 800 mA.
Sham Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand pain at 6 weeks after trancutaneous pulsed radiofrequency or sham	Hand pain measured in a 0-10 numeric rating scale after trancutaneous pulsed radiofrequency or sham	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand pain at 12 weeks after trancutaneous pulsed radiofrequency or sham	Hand pain measured in a 0-10 numeric rating scale after trancutaneous pulsed radiofrequency or sham	12 weeks
Efficacy of transcutaneous pulsed radiofrequency on hand function	Efficacy of trancutaneous pulsed radiofrequency on hand function (Australian/Canadian Hand Osteoarthritis Index [AUSCAN] function subscale, range 0-36, with higher scores indicating lower function)	6 weeks, 12 weeks
Efficacy of transcutaneous pulsed radiofrequency on hand stiffness	Efficacy of trancutaneous pulsed radiofrequency on hand stiffness (Australian/Canadian Hand Osteoarthritis Index [AUSCAN] stiffness subscale, range 0-4, with higher scores indicating more stiffness)	6 weeks, 12 weeks
Efficacy of transcutaneous pulsed radiofrequency on the number of tender joints	Efficacy of trancutaneous pulsed radiofrequency on the number of tender joints (Tender joint count)	6 weeks, 12 weeks
Efficacy of trancutaneous pulsed radiofrequency on anxiety	Efficacy of trancutaneous pulsed radiofrequency on anxiety measured with the Hospital Anxiety and Depression Scale, anxiety subscale, range 0-21, with higher scores indicating higher likeliness of anxiety, in patients with hand osteoarthritis	6 weeks, 12 weeks
Efficacy of trancutaneous pulsed radiofrequency on depression	Efficacy of trancutaneous pulsed radiofrequency on depression measured with the Hospital Anxiety and Depression Scale, depression subscale, range 0-21, with higher scores indicating higher likeliness of depression, in patients with hand osteoarthritis	6 weeks, 12 weeks
Global perceived effect of recovery due to trancutaneous pulsed radiofrequency	Global perceived effect of recovery due to trancutaneous pulsed radiofrequency, range 0-7, with lower scores indicating better outcomes, reported by patients with hand osteoarthritis	6 weeks, 12 weeks
Global perceived effect of satisfaction with trancutaneous pulsed radiofrequency	Global perceived effect of satisfaction with trancutaneous pulsed radiofrequency, range 0-7, with lower scores indicating better outcomes, reported by patients with hand osteoarthritis	6 weeks, 12 weeks
Effect of transcutaneous pulsed radiofrequency therapy on health related quality of life	Effect of transcutaneous pulsed radiofrequency therapy on health related quality of life measured with Short Form-36. Scores are standardized with a mean of 50 and sd of 10, with higher scores indicating better outcomes	6 weeks, 12 weeks
Effect of transcutaneous pulsed radiofrequency therapy on temporal summation assessed using a 256 mN PinPrick	Effect of transcutaneous pulsed radiofrequency therapy on abnormalities measured with temporal summation, scored as present or absent. Patients will receive a single stimulation with the pinprick, scored 0-10 on NRS pain, followed by 10 stimuli with the pinprick, of which the last stimulus is scores 0-10 on NRS pain. This is repeated 5 times. The single stimuli are averaged, as are the 10th stimuli, and the ratio between these averages is calculated. A ratio >2 is indicative of temporal summation.	6 weeks
Effect of transcutaneous pulsed radiofrequency therapy on numbness of the hand.	Effect of transcutaneous pulsed radiofrequency therapy on numbness scored as present or absent, based on 5 stimuli with the PinPrick. Any stimulus rated as numb is regarded abnormal.	6 weeks
Effect of transcutaneous pulsed radiofrequency therapy on allodynia	Effect of transcutaneous pulsed radiofrequency therapy on allodynia, scored as present or absent. Scoring based on stimuli with a standardized brush, which is used to apply 5 stimuli to the back of the hand. Any of the stimuli evoking pain (score of >0 on a 0-10 NRS) is regarded as abnormal.	6 weeks
Effect of transcutaneous pulsed radiofrequency therapy on PainDETECT scores	Effect of transcutaneous pulsed radiofrequency therapy on PainDETECT scores (range -1 to 38, with scores <13 indicating presence of neuropathic pain is unlikely, scores 13-18 indicating presence of neuropathic pain is undetermined and scores >18 indicating neuropathic pain presence is likely).	6 weeks, 12 weeks
Effect of transcutaneous pulsed radiofrequency therapy on Michigan Hand Outcome Questionnaire	Effect of transcutaneous pulsed radiofrequency therapy on MHOQ scores, ranged 0-100 per domain, with higher scores indicating better oucomes.	6 weeks, 12 weeks
Effect of transcutaneous pulsed radiofrequency therapy on AUSCAN pain scores	Effect of transcutaneous pulsed radiofrequency therapy on AUSCAN pain scores (Australian/Canadian Hand Osteoarthritis Index [AUSCAN] pain subscale, range 0-20, with higher scores indicating more pain)	6 weeks, 12 weeks
Effect of transcutaneous pulsed radiofrequency therapy on central sensitization index scores	Effect of transcutaneous pulsed radiofrequency therapy on central sensitization index scores, range 0-100, with higher scores indicating more signs of central sensitization.	6 weeks, 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of local inflammation at baseline on the efficacy of tPRF	Effect of local inflammation at baseline as measured by ultrasonography based on power doppler signal, effusion and gray scale synovitis, on the efficacy of tPRF in reducing pain in hand osteoarthritis.	6 weeks, 12 weeks
Effect of different QST profiles on tPRF efficacy	Effect of different profiles based on quantitative sensory testing on tPRF efficacy in treating pain in hand osteoarthritis.	6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: Margreet Kloppenburg, Prof. Dr., LUMC

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: P21.101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No