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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
Must not have
Unwillingness to receive brief experimental pain
Current use of opioid analgesics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not willing to experience brief experimental pain.
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I am currently taking opioid painkillers.
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I have an ongoing inflammatory or autoimmune condition.
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I am currently experiencing a severe pain condition.
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I have a chronic pain condition more painful than my fibromyalgia.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brain Imaging-fMRI
Secondary study objectives
Brain Imaging-EEG
Other study objectives
Brief Pain Inventory (BPI) - Pain Interference

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
138 Previous Clinical Trials
10,931 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,158 Total Patients Enrolled
Vitaly Napadow, PhDPrincipal InvestigatorSpaulding Rehabilitation Hospital
4 Previous Clinical Trials
153 Total Patients Enrolled
~67 spots leftby Jun 2027
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