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Pain, ChronicNCT06336447

VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain

A study testing Experimental: Group #1: Virtual Reality Headset and Group 2 No Virtual Reality Headset in people with Pain, Chronic, run by Northwestern University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Chronic
What is being tested?
Experimental: Group #1: Virtual Reality Headset and Group 2 No Virtual Reality Headset
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
12 Jan 2024to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing genicular RFA will be eligible for inclusion in the study
  • Patients with knee pain, baseline average of > 4/10
  • X-ray evidence of osteoarthritis of the knee
  • Pain duration of >6 weeks and no previous knee surgeries
  • Patients will also only be included who have never undergone a RFA on the affected knee

Who cannot join

  • Individuals who do not have evidence of osteoarthritis on X-ray,
  • Secondary gain expected to influence treatment outcomes
  • Poorly controlled psychiatric condition that could affect outcome (e.g. active substance abuse) or impose a barrier to participation
  • Chronic opioid use and anticoagulation therapy that cannot be stopped and could warrant a different treatment approach (e.g. phenol ablation)
  • Severe motion sickness
  • Seizure disorder
Show all 9Show fewer
  • Vision loss
  • Pregnant
  • Nursing

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Paul Fitzgerald, RN,BSN,MS contact

312-695-1064

p-fitzgerald2@northwestern.edu

United States1 site, 1 recruiting

  • Northwestern Medicine Pain Center

    Chicago, Illinois, 60611

    Paul Fitzgerald, 312-695-1064, p-fitzgerald2@northwestern.edu

    Jason Ross, MD

    Recruiting

Other trials in United States

About this study

Official title: Can Virtual Reality Improve Patient Tolerance in Patients Undergoing Water Cooled Genicular Nerve Radio Frequency Ablation in Patients With Chronic Knee Pain? A Randomized Controlled Trial

This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain.

The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures.

Conditions
Pain, Chronic
Being tested
Experimental: Group #1: Virtual Reality Headset, Group 2 No Virtual Reality Headset
Keywords
Pain, Knee Pain, Virtual Reality, Radio Frequency Ablation, Genicular Nerve Block
Medical subject headings
Chronic Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Group #1: Virtual Reality HeadsetOther

    Group 1 will be assigned to the Virtual Realtity Headset. Participants will wear the device for at least 10 minutes prior to the planned procedure. Subjects will receive standard procedure. The VR Headset will be removed 10 minutes after the planned procedure.

  • Group 2 No Virtual Reality HeadsetOther

    Group 2 will receive standard care without the use of the Virtuality Reality Heaset.

Study groups in NCT06336447
Study groupRoleWhat they receive
Group #1: Virtual Reality HeadsetExperimentalGroup 1 will be assigned to the Virtual Realtity Headset. Participants will wear the headset for at least 10 minutes prior to the planned procedure. Subjects will receive standard procedure. The VR Headset will be removed 10 minutes after the planned procedure.
Receives: Other: Experimental: Group #1: Virtual Reality Headset
Group 2 No Virtual Reality HeadsetActive comparatorGroup 2 will receive standard care without the use of the Virtuality Reality Headset.
Receives: Other: Group 2 No Virtual Reality Headset

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedural related pain

    Reported procedural related pain on a 0-10 verbal rating scale (VRS)

    Measured: 10 minutes after procedure

Secondary outcomes (5)

  1. Procedure related satisfaction

    Procedure related satisfaction on a 1-5 Likert scale (5=most satisfied, 1=least satisfied)

    Measured: 10 minutes after prodedure

  2. Post procedure anxiety

    Post-procedural numerical rating scale (NRS) for anxiety on an 11-point scale (0=no anxiety 10=worst possible level of anxiety)

    Measured: 10 minutes after procedure

  3. Mean reduction in pain 1 month after procedure

    Mean reduction on a 0-10 numerical rating scale (NRS) pain scores for average and worst knee pain at 1 month

    Measured: 30 days after procedure

  4. Midazolam administered

    Milligrams of midazolam administered during procedure for sedation

    Measured: 10 minutes before procedure to end of prodedure

  5. Fentanyl administered

    Micrograms of fentanyl administered during procedure

    Measured: 10 minutes before procedure to end of prodedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2024
  2. Study start12 Jan 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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
Model description
Randomized controlled trail.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06336447
Sponsor's protocol ID
STU00220295
Status last verified
Oct 2026
First submitted
21 Mar 2024
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.

    PubMed 24553908

  • Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/

    PubMed 29939661

  • Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.

    PubMed 34308957

  • Iannaccone F, Dixon S, Kaufman A. A Review of Long-Term Pain Relief after Genicular Nerve Radiofrequency Ablation in Chronic Knee Osteoarthritis. Pain Physician. 2017 Mar;20(3):E437-E444.

    PubMed 28339444

  • Hoffman HG, Richards TL, Van Oostrom T, Coda BA, Jensen MP, Blough DK, Sharar SR. The analgesic effects of opioids and immersive virtual reality distraction: evidence from subjective and functional brain imaging assessments. Anesth Analg. 2007 Dec;105(6):1776-83, table of contents. doi: 10.1213/01.ane.0000270205.45146.db.

    PubMed 18042882

  • Ding J, He Y, Chen L, Zhu B, Cai Q, Chen K, Liu G. Virtual reality distraction decreases pain during daily dressing changes following haemorrhoid surgery. J Int Med Res. 2019 Sep;47(9):4380-4388. doi: 10.1177/0300060519857862. Epub 2019 Jul 25.

    PubMed 31342823

  • Bair MJ, Wu J, Damush TM, Sutherland JM, Kroenke K. Association of depression and anxiety alone and in combination with chronic musculoskeletal pain in primary care patients. Psychosom Med. 2008 Oct;70(8):890-7. doi: 10.1097/PSY.0b013e318185c510. Epub 2008 Sep 16.

    PubMed 18799425

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Group #1: Virtual Reality Headset and Group 2 No Virtual Reality Headset in people with Pain, Chronic, run by Northwestern University at 1 site in United States.

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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. 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 United States. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paul Fitzgerald, RN,BSN,MS (312-695-1064, p-fitzgerald2@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural related pain (time frame: 10 minutes after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06336447, which also lists 7 linked publications.

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 29 Oct 2026.

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