Electroacupuncture Analgesia for Fibromyalgia

N/A

Recruiting

Led By Vitaly Napadow, PhD, LicAc

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

Study Summary

This trial aims to study how the brain and body's responses of patients and acupuncturists during treatment are related to the outcomes of the patients. Both healthy men and women as well as fib

Who is the study for?

This trial is for right-handed, English-speaking clinicians aged 25-60 and fibromyalgia patients aged 21-60. Patients must have been diagnosed with fibromyalgia for at least a year and be on stable medication doses for 30 days prior without changes during the trial.Check my eligibility

What is being tested?

The study examines how brain and body responses of both acupuncturists and patients during acupuncture affect patient outcomes. It involves electroacupuncture analgesia and use of a rapid cuff inflator to measure these responses.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include typical acupuncture risks such as minor bleeding, bruising, or soreness at needle sites; discomfort from the cuff inflator could also occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 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

Magnitude of patient/clinician concordance in brain activation of mirror brain circuitry during electroacupuncture therapy

Secondary outcome measures

Brain

Trial Design

3Treatment groups

Experimental Treatment

Group I: No InteractionExperimental Treatment2 Interventions

Phase 1: The clinician and the patient will first be introduced at the MRI sessions. During the MRI sessions, the patient will receive experimental pressure pain via the Hokanson Rapid Cuff Inflator and electroacupuncture analgesia to the leg for pain relief.

Group II: LongitudinalExperimental Treatment2 Interventions

Phase 2: Prior to first MRI session, both clinician and patient will go through a training visit. During the first MRI session, the patient will receive experimental pressure pain to the left leg via Hokanson Rapid Cuff Inflator and electroacupuncture to the same leg for pain relief. Following the first MRI session, the patient will attend biweekly acupuncture treatment sessions with the clinician (6 treatments total). During the first session the clinician will be introduced to the patient and do a general intake in addition to the acupuncture treatment. The final MRI session will be identical to the first. The patient will receive experimental pressure pain via Hokanson Rapid Cuff Inflator and electroacupuncture to the same leg for pain relief.

Group III: InteractionExperimental Treatment2 Interventions

Phase 1: Prior to the MRI sessions, the clinician will be introduced to the patient and do a general intake of physical examination. During the MRI sessions, the patient will receive experimental pressure pain via the Hokanson Rapid Cuff Inflator and electroacupuncture analgesia to the leg for pain relief.

Do I qualify?Apply below to find out