Fibromyalgia Clinical Trial
Official title:
A Study of the Effect of Rhythmic Sensory Stimulation on Fibromyalgia
Fibromyalgia is a chronic pain disorder associated with widespread pain that dramatically impacts patient's quality of life. The present research aims to determine the effectiveness of Rhythmic Sensory Stimulation with rhythmic gamma-frequency (30 - 120 Hz) acoustic-driven stimulation of mechanoreceptors in the body on the treatment of fibromyalgia. The proposed treatment involves 30 minutes of daily rhythmic vibroacoustic stimulation at gamma range, 5 days per week, for 5 weeks. Measures of pain severity, fibromyalgia symptoms, sleep quality, and depression, will be compared before and after treatment between the treatment and control groups. The results of the present study will help to better understand the effectiveness of Rhythmic Sensory Stimulation to the treatment of chronic pain disorders, such as fibromyalgia, and contribute to the development of future studies to investigate the neural driving effects of therapies based on Rhythmic Sensory Stimulation.
Fibromyalgia is a chronic pain disorder associated with widespread pain that dramatically
impacts patients' quality of life. Its exact cause has not yet been identified, however,
recent studies indicate that fibromyalgia is associated with a significant imbalance of the
connectivity within brain networks associated with pain, decreased functional connectivity in
the descending pain-modulating system, and increased activity in the pain matrix related to
central sensitization. It has been suggested that treatments that stimulate or induce
coherent neuronal activity, and synchronize dysregulated brain circuitry, have significant
benefits in improving pain management and enhancing patients' quality of life.
An example of a non-invasive treatment that is thought to indirectly stimulate neuronal
coherence is Rhythmic Sensory Stimulation (RSS) in gamma frequencies. RSS stimulates the
mechanoreceptors in the body using gamma-frequency sounds (e.g., 40 Hz) by means of speakers
in a chair. Previous research demonstrates significantly improved pain management in several
pain conditions (e.g., rheumatoid arthritis, low-back pain, sports injuries); however, little
is known about the effect of RSS with gamma-frequency sound stimulation on fibromyalgia. The
use of RSS to treat fibromyalgia was first explored very recently and findings indicate that
this treatment could be effective for individuals with fibromyalgia given that
gamma-frequency sound stimulation indirectly stimulates neuronal coherence.
Aim: The present study aims to examine the effects of gamma frequency rhythmic sensory
stimulation on fibromyalgia symptoms. Treatment effectiveness will be assessed by examining
whether sensory stimulation will produce clinically meaningful changes in fibromyalgia
symptom severity and whether treatment response will differ between the two treatment
parameters.
Intervention: Fifty patients with a formal diagnosis of fibromyalgia were randomly assigned
to two test groups. One group received vibrotactile stimulation from a continuous sine wave
single-frequency stimulation (40 Hz) for 30 minutes, five days per week, over five weeks,
concomitant with usual care. The second group completed the same treatment protocol but
received different stimulation consisting of random and intermittent complex wave gamma-range
vibrotactile stimulation. Measures of pain severity, fibromyalgia symptoms, sleep quality,
and depression will be compared before and after treatment between the two groups.
The results of the present study will help to better understand the effectiveness of RSS for
treatment of chronic pain disorders, such as fibromyalgia, and contribute to the development
of future studies to investigate the mechanisms underlying clinical responses to rhythmic
sensory stimulation.
;
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
|
||
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 |
NCT04571853 -
New Educational Tool for FM
|
N/A | |
Recruiting |
NCT04571528 -
Effectiveness of VIRTUAL FIBROWALK STUDY
|
N/A |