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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptom duration of at least 3 months
Tender points: having >10/18 tender points
Must not have
Peripheral neuropathy
Subjects scheduled for surgery will not be eligible to participate in this study until 6 weeks post-surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15
Summary
This trial will explore the use of microcurrent therapy for fibromyalgia patients and evaluate its effect on generalized pain and quality of life. The goal is to determine if microcurrent therapy can be self-administered by the patient as an adjunct to medical pain management.
Who is the study for?
This trial is for Active Duty or DoD beneficiaries aged 18-74 with fibromyalgia, experiencing widespread pain for at least 3 months and having more than 10 tender points. Participants must have had a neck injury in the past and be able to receive care at Nellis Air Force Base.
What is being tested?
The study tests if microcurrent therapy using a Transcutaneous Electrical Nerve Stimulator (TENS) can reduce generalized pain and improve life quality in fibromyalgia patients compared to a placebo device.
What are the potential side effects?
Microcurrent TENS may cause mild skin irritation where the electrodes are placed. There's also a small risk of discomfort or increased pain due to electrical stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My symptoms have lasted for at least 3 months.
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I have more than 10 tender points on my body.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have nerve damage in my hands or feet.
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I have not had surgery in the last 6 weeks.
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I have had surgery on my brain or spine.
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I have had surgery for trapped nerves.
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My cancer is currently active.
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I have received an organ transplant.
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I have severe bone deformities or stiff joints.
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I do not have any active infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measure Yourself Medical Outcome Profile (MYMOP)
Revised Fibromyalgia Impact Questionnaire (FIQR)
active range of motion (AROM)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MicrocurrentExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Paul CrawfordLead Sponsor
5 Previous Clinical Trials
917 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have nerve damage in my hands or feet.You have been diagnosed with fibromyalgia according to specific guidelines from the American College of Rheumatology.I do not abuse alcohol or drugs, but I may use medical marijuana.You have serious mental health problems.You must be able to receive medical care at Nellis Air Force Base to take part in this study.My symptoms have lasted for at least 3 months.I have not had surgery in the last 6 weeks.You have a pacemaker or other implanted electronic devices.You have had a strong allergic reaction to the surface electrode.Other medical conditions are ruled out.I have a heart rhythm problem.I have more than 10 tender points on my body.I have had surgery on my brain or spine.I am between 18 and 74 years old and am either active duty or a DoD beneficiary.I have had surgery for trapped nerves.My cancer is currently active.I have received an organ transplant.I have severe bone deformities or stiff joints.You have had a neck injury at any point in your life.I do not have any active infections.I experience pain in all areas of my body.I am between 18 and 74 years old and either active duty or a DoD beneficiary.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Microcurrent
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Fibromyalgia Patient Testimony for trial: Trial Name: NCT04949100 — N/A
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