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Microcurrent for Fibromyalgia

NCT04949100 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-12

No results posted yet for this study

Summary

Explore the use of microcurrent therapy for fibromyalgia patients and evaluate its effect on generalized pain and quality of life.

Determine if microcurrent therapy be effectively self-administered by the patient as an adjunct to medical pain management.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief

* Duration: 60 minutes. * Electrode placement: There will be one lead placed on the back of the neck and one placed on lower abdomen. * Frequency: Each lead delivers a dual channel microcurrent of 10 and 40 Hz simultaneously. * Amperage: Adjusted according to BMI: 100 μA for an underweight BMI less 20, 300μA for an overweight BMI greater than 30, and 200μA for normal BMI (20-30). Amperage may be adjusted to 20-300 μA according to comfort. * Positioning: The patient remains seated for the first 10 minutes with the investigator watching for any side effects. The patient may stand, sit, lie supine, et cetera for the remainder of treatment.

DEVICE

PLACEBO Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief

* Duration: 60 minutes. * Frequency: None * Electrode placement: There will be one lead placed on the back of the neck and one placed on lower abdomen. * Amperage: None * Positioning: The patient remains seated for the first 10 minutes, again, with the investigator watching for any side effects. The patient may stand, sit, lie supine, et cetera for the remainder of treatment.

Sponsors & Collaborators

  • Paul Crawford

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04949100 on ClinicalTrials.gov