What side effects are associated with this type of intervention?

Common treatments for chronic pain that involve distraction and sensory modulation, such as virtual reality (VR) and audiovisual (A/V) distraction, generally have few negative side effects. Mild adverse events associated with these treatments can include discomfort from the device, dizziness, and, in rare cases, motion sickness. These non-pharmacological interventions are considered safe and effective for reducing pain and discomfort during medical procedures.

What prior FDA approvals exist?

The FDA has approved several treatments for chronic pain that involve neuromodulation and sensory modulation. These include transcranial magnetic stimulation (TMS), which has shown efficacy in reducing pain in patients with episodic migraine with aura, and spinal cord stimulation (SCS), which is used for conditions like failed back surgery syndrome and chronic radicular pain. Additionally, noninvasive vagus nerve stimulation (nVNS) has been explored for episodic migraine. While VR for pain management is still under investigation, these approved treatments share a common mechanism of altering neural activity to alleviate pain.

What other types of research exist?

Promising novel alternatives to Virtual Reality for chronic pain treatment include remote electrical neuromodulation, transcranial magnetic stimulation (TMS), and noninvasive vagus nerve stimulation (nVNS). These therapies have demonstrated efficacy in clinical trials for pain relief and are non-invasive, making them suitable options for chronic pain management.

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Virtual Reality Therapy for Complex Regional Pain Syndrome

N/A

Recruiting

Led By Miles Fontenot, MD, Ph.D

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to wear a VR head-mounted display

Average pain score in the affected CRPS limb(s) greater than or equal to 3 out of 10

Must not have

Personal history of severe motion sickness

Severe systemic disease that is a constant threat to life (ASA class IV+)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 14 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using VR goggles can help people with chronic pain from CRPS by distracting them with a virtual world and teaching them relaxation techniques. Virtual reality (VR) has shown promising results for pain management, including chronic pain.

Who is the study for?

This trial is for adults over 18 with a confirmed diagnosis of CRPS I or II in one or both upper limbs, experiencing pain scores of 3 out of 10 or higher. Participants must have been on a stable treatment plan for at least four weeks and be able to use VR equipment and communicate in English. It's not suitable for those with severe motion sickness, life-threatening systemic diseases, or prisoners.

What is being tested?

The study examines whether immersive VR can alleviate chronic pain from CRPS. Participants will either do VR exercises in the clinic only, or they'll also get 'VR homework' to do outside the clinic. The effectiveness of these two approaches will be compared.

What are the potential side effects?

While VR is noninvasive and generally safe, some side effects may include temporary discomfort like headaches, eye strain, dizziness, or nausea—especially if prone to motion sickness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can wear a VR headset.

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My average pain score in the affected limb is 3 or more out of 10.

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I have been diagnosed with CRPS in my arm(s) according to the Budapest Criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a severe history of getting motion sick.

Select...

I have a severe illness that constantly threatens my life.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Patient Global Impression of Change scale (PGIC), regarding CRPS pain.

The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities

The Patient Global Impression of Change scale (PGIC), regarding functionality/physical abilities.

Secondary study objectives

Brief Pain Inventory (BPI) Short form, Pain interference scale.

CES-D Center for Epidemiologic Studies Depression Scale (CES-D), NIMH.

Mindfulness.

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Roosevelt "in Clinic VR" + "VR homeworks"Experimental Treatment1 Intervention

Patients in this group will receive VR physical therapy exercises "in clinic", during the two week treatment phase of the study (approximately 10 treatment sessions). They will also take a VR system home and will be encouraged to do VR home works at home, during this first two week period. After the first 2 weeks, all patients will do VR homeworks, including VR exercises and VR mindfulness.

Group II: Roosevelt "in clinic VR"Active Control1 Intervention

Patients in this group will receive VR physical therapy exercises "in clinic" only, during the two week treatment phase of the study (approximately 10 treatment sessions). After the first 2 weeks, all patients will do VR homeworks, including VR exercises and VR mindfulness.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for chronic pain, such as Virtual Reality (VR), interventional therapies, pharmacologic treatments, and mind-body practices, work through various mechanisms to alleviate pain. VR uses distraction and sensory modulation to alter pain perception by engaging the brain in immersive experiences, thereby reducing the focus on pain. Interventional therapies, like nerve blocks and spinal cord stimulation, target specific pain generators or modulate pain signals at the spinal level. Pharmacologic treatments, including NSAIDs, muscle relaxants, and antidepressants, work by reducing inflammation, relaxing muscles, or altering neurotransmitter levels to decrease pain. Mind-body practices, such as yoga and cognitive-behavioral therapy (CBT), aim to improve coping skills and reduce pain through psychological and physical engagement. These treatments are crucial for chronic pain patients as they offer multiple avenues to manage pain, improve function, and enhance quality of life.

The Use of Virtual Reality in Back Pain Rehabilitation: A Systematic Review and Meta-Analysis.The analgesic effects of opioids and immersive virtual reality distraction: evidence from subjective and functional brain imaging assessments.