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Transcutaneous Electrical Nerve Stimulation Device

Auricular transcutaneous electrical nerve stimulation device for Fibromyalgia

N/A
Waitlist Available
Led By Jian Kong
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet the American College of Rheumatology (ACR) 1990 classification criteria and the ACR 2010 diagnostic criteria for fibromyalgia as determined by clinicians.
Willingness to complete a 4-week, twice-a-day treatments.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2 and week 4.
Awards & highlights

Study Summary

This trial will test if TENS can relieve pain for those with Fibromyalgia. 60 subjects will be enrolled at Massachusetts General Hospital.

Eligible Conditions
  • Fibromyalgia

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2 and week 4.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2 and week 4. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Revised Fibromyalgia Impact Questionnaire (FIQR)
Secondary outcome measures
Beck Depression Inventory-II (BDI-II)
Blood inflammation markers (optional)
Brief Quantitative Sensory Testing (QST)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: taVNS Group1Experimental Treatment1 Intervention
This group will receive taVNS for 4 weeks.
Group II: taVNS Group 2Experimental Treatment1 Intervention
This group will receive taVNS for 4 weeks.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,775 Total Patients Enrolled
7 Trials studying Fibromyalgia
594 Patients Enrolled for Fibromyalgia
Jian KongPrincipal InvestigatorMGH
4 Previous Clinical Trials
257 Total Patients Enrolled

Frequently Asked Questions

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

Are participants currently being accepted to this research project?

"Affirmative. The information accessible on clinicaltrials.gov indicates that this medical examination has been actively searching for participants since its inception on 8/30/2021, with the most recent update occurring a day later. This trial is hoping to enlist 60 patients from a single site."

Answered by AI

May I participate in this experiment?

"Sixty individuals aged between 18 and 65 are sought for this fibromyalgia study. In order to qualify, participants must demonstrate a willingness to complete two-fold daily treatments over the course of four weeks, as well as meet American College of Rheumatology (ACR) 1990 classification criteria and ACR 2010 diagnostic requirements determined by clinicians."

Answered by AI

What is the sample size of this research project?

"Affirmative, the clinicaltrials.gov website displays that this research trial is currently looking for volunteers to join in. This study was introduced on August 30th 2021 and has yet been updated at the same date. The experiment requires 60 individuals across 1 site of enrollment to take part in it."

Answered by AI

Are any participants aged 25 and older accepted into this clinical investigation?

"This research study is open to participants aged 18-65. Moreover, there are 7 trials for minors and 75 studies for seniors."

Answered by AI
~17 spots leftby Mar 2025