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Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain (PROAP)

Primary Purpose

Hand Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Transcutaneous pulsed radiofrequency
Sham
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Osteoarthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Carpal tunnel syndrome
  • Diabetes
  • History of chemo- and/or radiotherapy
  • Spinal surgery or spinal trauma with lasting complaints
  • Cognitive impairment
  • Pregnancy or breast-feeding
  • Eye surgery
  • Use of hard contact lenses for 3 or more months
  • Presence of an implantable cardioverter-defibrillator (ICD), neurostimulator or pacemaker

Sites / Locations

  • Leiden University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Transcutaneous pulsed radiofrequency

Sham

Arm Description

After signing informed consent, patients assigned to the intervention group by randomization will receive a single treatment with transcutaneous pulsed radiofrequency.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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)
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)
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)
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
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
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
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
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

Full Information

First Posted
December 17, 2021
Last Updated
July 1, 2022
Sponsor
Leiden University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05217979
Brief Title
Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain
Acronym
PROAP
Official Title
Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous pulsed radiofrequency
Arm Type
Active Comparator
Arm Description
After signing informed consent, patients assigned to the intervention group by randomization will receive a single treatment with transcutaneous pulsed radiofrequency.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous pulsed radiofrequency
Intervention Description
single treatment with transcutaneous pulsed radiofrequency, for a duration of 15 minutes, at a strength of 800 mA.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
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
Primary Outcome Measure Information:
Title
Hand pain at 6 weeks after trancutaneous pulsed radiofrequency or sham
Description
Hand pain measured in a 0-10 numeric rating scale after trancutaneous pulsed radiofrequency or sham
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Hand pain at 12 weeks after trancutaneous pulsed radiofrequency or sham
Description
Hand pain measured in a 0-10 numeric rating scale after trancutaneous pulsed radiofrequency or sham
Time Frame
12 weeks
Title
Efficacy of transcutaneous pulsed radiofrequency on hand function
Description
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)
Time Frame
6 weeks, 12 weeks
Title
Efficacy of transcutaneous pulsed radiofrequency on hand stiffness
Description
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)
Time Frame
6 weeks, 12 weeks
Title
Efficacy of transcutaneous pulsed radiofrequency on the number of tender joints
Description
Efficacy of trancutaneous pulsed radiofrequency on the number of tender joints (Tender joint count)
Time Frame
6 weeks, 12 weeks
Title
Efficacy of trancutaneous pulsed radiofrequency on anxiety
Description
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
Time Frame
6 weeks, 12 weeks
Title
Efficacy of trancutaneous pulsed radiofrequency on depression
Description
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
Time Frame
6 weeks, 12 weeks
Title
Global perceived effect of recovery due to trancutaneous pulsed radiofrequency
Description
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
Time Frame
6 weeks, 12 weeks
Title
Global perceived effect of satisfaction with trancutaneous pulsed radiofrequency
Description
Global perceived effect of satisfaction with trancutaneous pulsed radiofrequency, range 0-7, with lower scores indicating better outcomes, reported by patients with hand osteoarthritis
Time Frame
6 weeks, 12 weeks
Title
Effect of transcutaneous pulsed radiofrequency therapy on health related quality of life
Description
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
Time Frame
6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 Carpal tunnel syndrome Diabetes History of chemo- and/or radiotherapy Spinal surgery or spinal trauma with lasting complaints Cognitive impairment Pregnancy or breast-feeding Eye surgery Use of hard contact lenses for 3 or more months Presence of an implantable cardioverter-defibrillator (ICD), neurostimulator or pacemaker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margreet Kloppenburg, Prof. Dr.
Phone
+31(0)715263423
Email
g.kloppenburg@lumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Vlot, MSc
Phone
+31(0)715263592
Email
j.a.vlot@lumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margreet Kloppenburg, Prof. Dr.
Organizational Affiliation
LUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Centre
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margreet Kloppenburg, Prof. Dr.
Phone
+31715263423
Email
g.kloppenburg@lumc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain

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