The nitrous oxide group for Complex Regional Pain Syndrome

Phase 3

Waitlist Available

Led By Jason Hale, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one-week and one-month follow-ups.

Awards & highlights

Pivotal Trial

Summary

This trial tests if breathing a mix of nitrous oxide and oxygen can help chronic pain patients, especially those with spinal cord stimulators, by reducing their pain and making them feel more relaxed. Nitrous oxide has been used in various settings for pain management, including emergency departments and dental treatments, showing potential for both acute and chronic pain relief.

Eligible Conditions

Complex Regional Pain Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one-week and one-month follow-ups after treatments were ended

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one-week and one-month follow-ups after treatments were ended

This trial's timeline: 3 weeks for screening, Varies for treatment, and one-week and one-month follow-ups after treatments were ended for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pain Score

Secondary study objectives

PGIC Scale

PROMIS-29 Survey Physical Health Z-score, Mental Health Z-score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: The nitrous oxide groupActive Control1 Intervention

Nitrous oxide group will receive 50% nitrous oxide mixed with 50% oxygen, inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit.

Group II: The Control GroupPlacebo Group1 Intervention

Control group will receive 50% oxygen, inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit.

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