NCT05217979

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

December 17, 2021

Last Update Submit

November 9, 2023

Conditions

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Hand pain at 12 weeks after trancutaneous pulsed radiofrequency or sham

    12 weeks

  • Efficacy of transcutaneous pulsed radiofrequency on hand function

    6 weeks, 12 weeks

  • Efficacy of transcutaneous pulsed radiofrequency on hand stiffness

    6 weeks, 12 weeks

  • Efficacy of transcutaneous pulsed radiofrequency on the number of tender joints

    6 weeks, 12 weeks

  • Efficacy of trancutaneous pulsed radiofrequency on anxiety

    6 weeks, 12 weeks

  • +11 more secondary outcomes

Other Outcomes (2)

  • Effect of local inflammation at baseline on the efficacy of tPRF

    6 weeks, 12 weeks

  • Effect of different QST profiles on tPRF efficacy

    6 weeks, 12 weeks

Study Arms (2)

Transcutaneous pulsed radiofrequency

ACTIVE COMPARATOR

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

Sham

SHAM COMPARATOR

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

Interventions

Transcutaneous pulsed radiofrequencyDEVICE

single treatment with transcutaneous pulsed radiofrequency, for a duration of 15 minutes, at a strength of 800 mA.

Transcutaneous pulsed radiofrequency
ShamDEVICE

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

Sham

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Centre

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Study Officials

  • Margreet Kloppenburg, Prof. Dr.

    LUMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margreet Kloppenburg, Prof. Dr.

CONTACT

+31(0)715263423g.kloppenburg@lumc.nl

Miranda Van Lunteren, Dr

CONTACT

+31(0)715263592onderzoekcoreum@lumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 17, 2021

First Posted

February 1, 2022

Study Start

April 4, 2022

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)