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Procedure

Cognitive Training + Electroacupuncture for Fibromyalgia

N/A

Recruiting

Led By Vitaly Napadow, PhD

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

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

Must have

Pain duration of at least 6 months

Are on stable doses of medication for 30 days prior to entering the study and agree not to change medications or dosages during the trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial will assess the effectiveness of a new non-medicinal, multi-faceted therapy for fibromyalgia pain relief. It will also look into how patient-therapist relationships can help.

Who is the study for?

This trial is for individuals with Myofascial Pain Syndrome or Fibromyalgia who meet specific criteria, have a pain intensity of at least 4/10, and have been in pain for over six months. Participants must be on stable medication doses and agree not to change them during the study. They can't join if they work in pain treatment, have certain mental health conditions, contraindications to fMRI scans like metal implants or pacemakers, use opioids, or are pregnant.Check my eligibility

What is being tested?

The trial tests cognitive training combined with electroacupuncture to see if it improves brain coordination and reduces chronic pain. It's non-drug-based and follows recommendations for managing chronic pain. The study will also explore how therapeutic relationships affect pain outcomes using neural models.See study design

What are the potential side effects?

While the document does not specify side effects directly related to cognitive training or electroacupuncture within this context, generally these interventions may cause discomfort at needle insertion sites for acupuncture and temporary soreness.

Eligibility Criteria

Inclusion Criteria

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

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I have been experiencing pain for at least 6 months.

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I have been on the same medication dose for 30 days and agree not to change it during the trial.

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My pain level is at least a 4 out of 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brain Imaging-fMRI

Secondary outcome measures

Brain Imaging-EEG

Other outcome measures

Brief Pain Inventory (BPI) - Pain Interference

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive TrainingExperimental Treatment2 Interventions

Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia.

Group II: Education TrainingActive Control2 Interventions

Participants will meet with a pain specialist to receive education training related to fibromyalgia.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Training

2008

Completed Phase 3

~4100

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,750 Total Patients Enrolled

4 Trials studying Fibromyalgia

9,732 Patients Enrolled for Fibromyalgia

Spaulding Rehabilitation HospitalLead Sponsor

135 Previous Clinical Trials

10,955 Total Patients Enrolled

5 Trials studying Fibromyalgia

388 Patients Enrolled for Fibromyalgia

Vitaly Napadow, PhDPrincipal InvestigatorSpaulding Rehabilitation Hospital

4 Previous Clinical Trials

153 Total Patients Enrolled

1 Trials studying Fibromyalgia

20 Patients Enrolled for Fibromyalgia

Frequently Asked Questions

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

Is this investigation accommodating participants aged twenty or older?

"This experiment is only open to those that are above the age of consent and under 65 years old."

Answered by AI

May I join in on this investigation?

"To be considered for this fibromyalgia trial, an individual must have a diagnosis of the condition and fall within the 18 to 65 age range. A total cohort size of 100 has been recruited."

Answered by AI

Are there any remaining vacancies available for trial participants?

"According to clinicaltrials.gov, this medical study is not currently enrolling patients. The trial was launched on December 1st 2023 and has since been edited on November 27th of the same year. However, there are 102 other trials actively seeking participants in the present moment."

Answered by AI