Fibromyalgia Clinical Trial
Official title:
Efficacy of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Idiopathic Pain Syndromes : a Double Blind Sham Controlled Study
Objectives : To investigate the analgesic effects of repeated sessions of unilateral rTMS in
patients with chronic pain syndrome due to fibromyalgia, IBS or burning mouth syndrome.
Primary outcome will be numerical pain scores.
Methods : The study will be randomized and performed in parallel groups and double blind
versus sham stimulation, and will include 90 patients (45 patients per treatment arm). The
randomization will be computerized and performed for each aetiological group separately. The
rTMS will be performed on the left motor cortex, 5 consecutive days , then once a week
during 3 weeks then twice a month during 2 months, then once a month during 6 months.
Clinical assessment will include an assessment of pain, quality of life, sleep, depression
and anxiety, catastrophizing, and a neuropsychological evaluation.
Conclusion : this study should allow to determine for the first time the long term efficacy
and safety of rTMS in the treatment of dysfunctional or idiopathic chronic pain syndromes
which are often refractory to conventional treatments.
Several lines of evidence suggest that fibromyalgia syndrome, Irritable Bowel syndrome (IBS)
and burning mouth syndrome are chronic pain disorders affecting pain modulation. Repetitive
transcranial magnetic stimulation (rTMS) is a recent, safe and non-invasive technique for
stimulating the cerebral cortex, which has recently been reported to induce short term
analgesic effects in patients with chronic focal pain. We have also recently shown in a
double blind randomized trial, that rTMS could have short term analgesic effects in patients
with fibromyalgia.
Objectives : Our aim is to investigate the long term analgesic effects of repeated sessions
of unilateral rTMS in patients with chronic pain syndrome due to fibromyalgia, IBS or
burning mouth syndrome. Primary outcome will be numerical pain scores on brief pain
inventory at each visit.
Methods : This study will be randomized and performed in parallel groups and double blind
versus sham stimulation. It will include at least 30 patients per pain disorder, ie 90
patients. Randomization will be computerized and performed for each of the aetiological
groups separately (ie, there will be 3 distinct randomization procedures for fibromyalgia,
IBS and stomatodynia);. Stimulation will be applied to the right motor area corresponding to
the contralateral hand. The treatment will consist in a first period of 5 consecutive days
of stimulation, followed by a stimulation once a week during 3 weeks then a stimulation
twice a month during 2 months then stimulation once a month during 3 additional months.
Clinical assessment will be performed at baseline, then at day 1, 5, weeks 3, 5, 7, 9, 13
and 25. It will include depending on the visits an assessment of pain intensity and
characteristics, quality of life, sleep, depression and anxiety, catastrophizing, and a
brief neuropsychological evaluation (focusing on memory, attention and vigilance). In
patients with fibromyalgia, the evaluation will also include specifically the number of
tender points. In patients with IBS, evaluation of bowel dysfunction will also be performed.
Conclusion : This study should allow to determine for the first time the long term efficacy
and safety of rTMS in the treatment of dysfunctional or idiopathic chronic pain syndromes
which are often refractory to conventional treatments.
;
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 |
NCT03227952 -
Sensory Stimulation in Fibromyalgia
|
N/A | |
Completed |
NCT03166995 -
Postural Exercises in Women With 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 |
NCT04571853 -
New Educational Tool for FM
|
N/A | |
Recruiting |
NCT04571528 -
Effectiveness of VIRTUAL FIBROWALK STUDY
|
N/A |