Fibromyalgia Clinical Trial
Official title:
The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients
The purpose of this study is to determine whether persons treated with a low-intensity, noninvasive form of cortical electrical stimulation experience a reduction in symptoms of fibromyalgia different than persons receiving a sham treatment. Outcome measures include reduction in patient pain levels and improvement in sleep measures.
There is increasing acceptance that pain in fibromyalgia is a result of dysfunctional
sensory processing in the spinal cord and brain. Electrical cortical stimulation is a
device-based form of therapy that is increasingly being considered as an adjuvant to current
medical modalities for the treatment of chronic pain conditions such as fibromyalgia. The
investigators propose that stimulation of cortical areas believed to be involved in
dysfunctional sensory processing may have a beneficial influence on fibromyalgia symptoms.
The aim of this randomized double blind, placebo controlled study is to evaluate the
efficacy, safety, and tolerability of noninvasive cortical stimulation in the management of
fibromyalgia symptoms. More specifically, an active treatment group of subjects will receive
the study's cortical stimulation protocol twice a week for 11 weeks and will be evaluated
within 14 days following end of treatment, for a total timeframe of 13 weeks. In comparison,
a similar group of subjects will receive the same treatment protocol without the actual
stimulation signal being applied. The signal utilized is a modulated form that permits very
low-intensity signals to pass through outer tissues with less attenuation due to tissue
impedance. The signals are of a sufficiently low strength that they are below the level of
perception. Hence subjects cannot feel the signal, and are therefore blinded to treatment
arm. Investigators and clinical staff are also blinded. Outcome measures include
post-treatment to baseline changes in tender points, sleep characteristics as measured by
visual analog scales, and outcomes instruments including the Fibromyalgia Impact
Questionnaire.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05659862 -
Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT03042728 -
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
|
N/A | |
Recruiting |
NCT06097091 -
Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia
|
N/A | |
Recruiting |
NCT04554784 -
Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
|
N/A | |
Completed |
NCT03300635 -
Metabolism, Muscle Function and Psychological Factors in Fibromyalgia
|
N/A | |
Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
Completed |
NCT03166995 -
Postural Exercises in Women With Fibromyalgia
|
N/A | |
Completed |
NCT03227952 -
Sensory Stimulation in Fibromyalgia
|
N/A | |
Recruiting |
NCT06237595 -
Vagus Nerve Stimulation in Fibromyalgia
|
N/A | |
Completed |
NCT01888640 -
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
|
N/A | |
Completed |
NCT03641495 -
Pain Education and Therapeutic Exercise for Fibromyalgia
|
N/A | |
Recruiting |
NCT05581628 -
FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
|
||
Active, not recruiting |
NCT05128162 -
Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia
|
Phase 2 | |
Completed |
NCT04674878 -
Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia
|
N/A | |
Active, not recruiting |
NCT04084795 -
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
|
N/A | |
Completed |
NCT03129906 -
Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
|
N/A | |
Completed |
NCT05058911 -
Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia
|
N/A | |
Recruiting |
NCT04571528 -
Effectiveness of VIRTUAL FIBROWALK STUDY
|
N/A | |
Recruiting |
NCT04571853 -
New Educational Tool for FM
|
N/A |