CLINICAL TRIAL

Treatment for Fibromyalgia

Recruiting · 18+ · All Sexes · Chicago, IL

Nitrous Oxide as Treatment for Fibromyalgia

See full description

About the trial for Fibromyalgia

Eligible Conditions
Fibromyalgia · Myofascial Pain Syndromes · Neuralgia · Central Neuropathic Pain

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Control Group 1
Nitrous oxide gas for inhalation
DRUG
Control Group 2
Placebo
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
2016 American College of Rheumatology Revised criteria for fibromyalgia (2016-ACR)
Subjects 18 -75 years of age.
Self-reported pain of at least 4 on the Numeric Pain Rating Scale (NPRS) at screening and baseline.
Subject receives and agrees to remain on their stable fibromyalgia treatment plan established at least 4 weeks prior to dosing. Stable means no change in dose or any pain medication.
You are currently on psychotherapy show original
You are able to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Over 8-weeks from baseline
Screening: ~3 weeks
Treatment: Varies
Reporting: Over 8-weeks from baseline
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Over 8-weeks from baseline.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome, 4 secondary outcomes, and 1 other outcome in patients with Fibromyalgia. Measurement will happen over the course of Over 8-weeks from baseline (length of study participation).

Changes in FIQR
OVER 8-WEEKS FROM BASELINE (LENGTH OF STUDY PARTICIPATION)
Evaluation of response and remission will be based on 'Fibromyalgia Impact Questionnaire-Revised' (FIQR). This validated self-report diagnostic contains 21-questions to rate fibromyalgia effects over the prior 7-days. Domain 1: 9-questions rating function: 'No difficulty = 0' to 'Very difficult = 10' Domain 2: 2-questions rating overall impact: 'Never = 0' to 'Always = 10' Domain 3: 10-questions rating symptom intensity: 'None = 0' to 'Worst = 10' First: Sum the scores for each of the 3 domains (function, overall, and symptoms). Second: Divide domain 1 score by 3, leave domain 2 score unchanged, and divide domain 3 score by 2. Third: Add the 3 resulting domain scores to obtain the total FIQR score.
OVER 8-WEEKS FROM BASELINE (LENGTH OF STUDY PARTICIPATION)
Changes in Global Impression of Change Scale
OVER 8-WEEKS FROM BASELINE (LENGTH OF STUDY PARTICIPATION)
The Global Impression of Change Scale (PGI-C), a two question, self-report diagnostic evaluating the patients belief of treatment efficacy. - Patients rate their neuropathic pain ['No pain = 0' to 'Worst = 10'], and evaluate treatment effectiveness ['Very Much Improved'; 'Much Improved'; 'Minimally'; 'Improved'; 'No Change'; 'Minimally Worse'; 'Much Worse'; 'Very Much Worse']
OVER 8-WEEKS FROM BASELINE (LENGTH OF STUDY PARTICIPATION)
Hospital Anxiety and Depression Scale
OVER 8-WEEKS FROM BASELINE (LENGTH OF STUDY PARTICIPATION)
The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire comprising of 14-questions (7-anxiety and 7-depression), with response scores ranging: '0' to '3' Sum Depression scores = 0 to 21 Sum Anxiety scores = 0 to 21 Score range for each item (depression and anxiety): 0-7 = Normal 8-10 = Borderline abnormal (mild) 11-14 = Abnormal (moderate) 15-21 = Severe
OVER 8-WEEKS FROM BASELINE (LENGTH OF STUDY PARTICIPATION)
Monitor changes in NPRS score
OVER 8-WEEKS FROM BASELINE (LENGTH OF STUDY PARTICIPATION)
Monitoring changes in 'Numeric Pain Rating Scale' (NPRS) diagnostic score to determine effectiveness a 60-minute session of inhaled 50% nitrous oxide vs placebo has on symptoms associated with fibromyalgia. The NPRS is a validated self-report diagnostic asking patients to indicate the intensity of current, best, and worst pain levels over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable). Response and remission will be based on a 30% improvement in average daily mean (max and min) NPRS score.
OVER 8-WEEKS FROM BASELINE (LENGTH OF STUDY PARTICIPATION)
Adverse events
OVER 8-WEEKS (LENGTH OF STUDY PARTICIPATION)
AEs such as nausea and vomiting; or any other AEs determined probably, possibly, or unrelated to the study intervention. Study patient safety is monitored by the investigators (MD) with experience in critical care anesthesia, as well as an experienced clinical research team responsible for recording and reporting events.
OVER 8-WEEKS (LENGTH OF STUDY PARTICIPATION)
Computerize Adaptive Testing - Mental Health (CAT-MH) measurements
OVER 8-WEEKS FROM BASELINE
This CAT-MH is a validated self-reporting diagnostic that adaptively selects a small optimal set of items from a large bank of approximately 1,500 items, targeted to individuals current or historical level of severity and likelihood of 'depression'. Generated scores include severity and liklihood percentile: depression = (%) normal, mild, moderate, severe
OVER 8-WEEKS FROM BASELINE

Patient Q & A Section

Ask a question about the study

Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Fibromyalgia by sharing your contact details with the study coordinator.