Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain (PROAP)

November 9, 2023 updated by: Margreet Kloppenburg, MD PhD, Leiden University Medical Center
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333 ZA
        • Recruiting
        • Leiden University Medical Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hand pain at 6 weeks after trancutaneous pulsed radiofrequency or sham
Time Frame: 6 weeks
Hand pain measured in a 0-10 numeric rating scale after trancutaneous pulsed radiofrequency or sham
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hand pain at 12 weeks after trancutaneous pulsed radiofrequency or sham
Time Frame: 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks
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.
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of local inflammation at baseline on the efficacy of tPRF
Time Frame: 6 weeks, 12 weeks
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
Time Frame: 6 weeks, 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Leiden University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Margreet Kloppenburg, Prof. Dr., LUMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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