Hand OsteoarthritisPROAPNCT05217979
Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain
A study testing Transcutaneous pulsed radiofrequency in people with Hand Osteoarthritis, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Transcutaneous pulsed radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Apr 2022to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Hand osteoarthritis according to the ACR criteria
- Hand pain of at least 30mm on a 100mm VAS
- Chronic hand pain
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Centre
Leiden, South Holland, 2333 ZA
Margreet Kloppenburg, Prof. Dr., +31715263423, g.kloppenburg@lumc.nl
About this study
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.
Read the 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.
- Conditions
- Hand Osteoarthritis
- Being tested
- Transcutaneous pulsed radiofrequency, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous pulsed radiofrequencyDevice
single treatment with transcutaneous pulsed radiofrequency, for a duration of 15 minutes, at a strength of 800 mA.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (16)
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start4 Apr 2022
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margreet Kloppenburg, MD PhD, Leiden University Medical Center
- Investigators
- Margreet Kloppenburg, Prof. Dr., Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217979
- Sponsor's protocol ID
- P21.101
- Acronym
- PROAP
- Status last verified
- Nov 2023
- First submitted
- 17 Dec 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain
- ClinicalTrials.gov ID
- NCT05217979
- Acronym / sponsor ID
- PROAP / P21.101
- Conditions
- Hand Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous pulsed radiofrequency | Active comparator | Device: Transcutaneous pulsed radiofrequencyAfter signing informed consent, patients assigned to the intervention group by randomization will receive a single treatment with transcutaneous pulsed radiofrequency. |
| Sham | Sham comparator | Device: ShamAfter 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80
- Hand osteoarthritis according to the ACR criteria
- Hand pain of at least 30mm on a 100mm VAS
- Chronic hand pain
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous pulsed radiofrequencysingle treatment with transcutaneous pulsed radiofrequency, for a duration of 15 minutes, at a strength of 800 mA. | Device | Transcutaneous pulsed radiofrequency |
| ShamSham 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 | Device | Sham |
Primary outcome
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
16 secondary outcomes
Hand pain at 12 weeks after trancutaneous pulsed radiofrequency or sham
Time frame: 12 weeks
Efficacy of transcutaneous pulsed radiofrequency on hand function
Time frame: 6 weeks, 12 weeks
Efficacy of transcutaneous pulsed radiofrequency on hand stiffness
Time frame: 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 anxiety
Time frame: 6 weeks, 12 weeks
Efficacy of trancutaneous pulsed radiofrequency on depression
Time frame: 6 weeks, 12 weeks
Global perceived effect of recovery due to trancutaneous pulsed radiofrequency
Time frame: 6 weeks, 12 weeks
Global perceived effect of satisfaction with trancutaneous pulsed radiofrequency
Time frame: 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 temporal summation assessed using a 256 mN PinPrick
Time frame: 6 weeks
Effect of transcutaneous pulsed radiofrequency therapy on numbness of the hand.
Time frame: 6 weeks
Effect of transcutaneous pulsed radiofrequency therapy on allodynia
Time frame: 6 weeks
Effect of transcutaneous pulsed radiofrequency therapy on PainDETECT scores
Time frame: 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 AUSCAN pain scores
Time frame: 6 weeks, 12 weeks
Effect of transcutaneous pulsed radiofrequency therapy on central sensitization index scores
Time frame: 6 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margreet Kloppenburg, Prof. Dr. principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous pulsed radiofrequency in people with Hand Osteoarthritis, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margreet Kloppenburg, Prof. Dr. (+31(0)715263423, g.kloppenburg@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand pain at 6 weeks after trancutaneous pulsed radiofrequency or sham (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.