Repetitive Transcranial Magnetic Stimulation of Relief of Fibromyalgia Pain

JRCT ID: jRCTs052190087

Registered date:23/12/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: fibromyalgia
• Date of first enrollment: 25/06/2020
• Target sample size: 10
• Countries of recruitment: Brazil,Japan,France,Japan,Australia,Japan,Spain,Japan
• Study type: Interventional
• Intervention(s): repetitive transcranial magnetic stimulation

Outcome(s)

Primary Outcome

Pain intensity (NRS 0-10) at the 8th week of treatment
(Percentage of responders based on the reduction of >=50% in pain intensity (NRS 0-10) compared to baseline)

Secondary Outcome

1. Global impression of change (% of very much and much improved) at the 8th week and 16th week.
2. Pain intensity (NRS 0-10) at the end of the induction period (10th day) and after the end of fortnight maintenance stimulation period (12th week).
3. Mood (Hospital Anxiety and Depression Scale) (8th week)
4. Medication use (Brief Pain Inventory) (8th week)
5. Fibromyalgia Impact Questionnaire (FIQ) (8th week and 16th week)
6. American college of rheumatology 2016 fibromyalgia criteria (8th week)
7. Adverse events (standardized assessment)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Female

Include criteria

(1) Female patients with diagnosis fibromyalgia according to the ACR 2016 criteria (patient satisfies modified 2016 fibromyalgia criteria if the following 3 conditions are met
i) widespread pain index (WPI) >= 7 and symptom severity scale (SSS) score >= 5 or WPI of 3-6 and SSS score >= 9.
ii) Generalized pain, defined as pain in at least 4 of 5 regions, must be present. Jaw, chest, and abdominal pain are not included in generalized pain definition.
iii) Symptoms have been generally present for at least 3 months.
(2) Persistent pain for more than 6 months before enrollment.
(3) Stable treatment for atleast 2 months before enrollment and throughout the study.
(4) Age of 20 to 80 years.
(5) Right-handed patients.
(6) Be able to understand study protocol and give signed, written informed consent.
(7) NRS score >= 4/10

Exclude criteria

(1) Known abuse of alcohol or illicit drugs
(2) Known psychiatric conditions (DSM-V)
(3) Contraindications to rTMS (Head trauma or concussion, metal implants in the skull, cardiac pacemaker, medication infusion devices, previous troubles with TMS or MRI)
(4) Pregnancy or breastfeeding
Being under chronic contraceptive use (intrauterine dispositive or oral contraceptive)
(5) Other medical conditions demand hospitalization;
(6) Participation in other clinical studies at the same time
(7) Use of strong opioids
(8) Transcranial magnetic stimulation-naive
(9) Inflammatory rheumatic disease, autoimmune disease, or other painful disorders that might confound the assessment of fibromyalgia pain
(10) On medications known to increase the risk of TMS-induced seizures (eg, theophylline, Ritalin, high-dose thyroid supplementation)
(11) If they had medication changes within 4 weeks of starting the trial or during the trial
(12) Neurologic disorders
(13) If they had stroke, bipolar disorder, or schizophrenia

Related Information

• Primary Sponsor: Kishima Haruhiko
• Secondary ID(s): NCT03658694