Fibromyalgia, Neuropathic Pain
Conditions
Keywords
Neuropathic pain - Fibromyalgia - deep rTMS
Brief summary
This study will investigate the efficacy and safety of "deep" rTMS on neuropathic pain or fibromyalgia. It will be randomized and sham controlled and will last 3 months. Patients will be randomized to receive acctive rTMS or sham rTMS and will receive repeated rTMS sessions (5 daily sessions then one session per week then every 2 to 3 weeks for up to 10 weeks).
Detailed description
This double blind sham controlled parallel group bicenter study will assess the efficacy and safety of repeated sessions of deep rTMS using H coil in patients with neuropathic pain or fibromyalgia. Primary outcome will be % of pain relief at week 13.
Interventions
DEVICEDeep active rTMS with Hesed coil
This brain neurostimulation method targets the motor cortex bilaterally
DEVICESham rTMS with Hesed coil
This brain sham neurostimulation method targets the motor cortex bilaterally
Sponsors
Nadine ATTAL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Chronic pain ≥ 6 months, at least 4/10 on a 0-10 NRS, present every day or nearly every day * Neuropathic pain (confirmed with Douleur Neuropathique en 4 questions and international criteria from NeuPSIG) or fibromyalgia (revised ACR criteria) * Stable concomitant medications for pain for at least one month * Able to fill out questionnaires and understand and speak French
Exclusion criteria
* Contraindications to rTMS * Prior treatment with rTMS * Progressive severe condition (eg cancer) * Psychosis * Psychoactive drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of rTMS versus sham rTMS on pain relief at 13 weeks | 13 weeks | Pain relief scale from the Brief Pain Inventory rated from 0 to 100 % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of rTMS vs sham on average pain intensity | Each follow up visit at the pain center for up to 13 weeks | Average pain intensity from the Brief Pain Inventory rated from 0 to 10 on a 0-10 numerical pain scale |
| Effects of rTMS vs sham on pain interference | Baseline then each follow up visit at the pain center for up to 13 weeks | pain interference from Brief Pain Inventory rated from 0 to 70 (total score) |
| Effects of rTMS vs sham on quality of life | Baseline then each follow up vist at the pain center for up to 13 weeks | Euroqol scale which includes 5 dimensions of quality of life and a 0-100 visual analog scale |
| Side effects of rTMS or sham | Each follow up visit at the pain center for up to 13 weeks | Any side effects reported by the patients assessed at each visit after each treatment session and rated as mild, moderate or severe |
| Comparison of the efficacy of rTMS on the primary outcome between patients with neuropathic pain and fibromyalgia | Week 13 | Comparison of both populations on the pain relief scale from the Brief Pain Inventory (0-100 %) |
| Blinding assessment | 13 weeks | Blindinq questionnaire at 13 weeks(end of the study) |
| Patient global impression of change | 13 weeks | Patient global impression of change at 13 weeks (from much improved to much deteriorated) |
| Self-reported pain intensity | Baseline then every day at the same time of day (morning or evening) | Average pain intensity from past 24 hours based on 0-10 numerical pain scale |
| Effects of rTMS versus sham on anxiety and depressive symptoms | Baseline then each follow up visit at the pain center for up to 13 weeks | Anxiety and depressive symptoms of the Hospital Anxiety and Depressive scale rated from 0 to 21 for anxiety and 0 to 21 for depression |
| Effects of rTMS vs sham on pain as its worst from Brief Pain Inventory | Baseline then each follow up visit at the pain center for up to 13 weeks | pain intensity on 0-10 numerical rating scale |
| Effects of rTMS vs sham on pain as its least from Brief Pain Inventory | Baseline then each follow up visit at the pain center for up to 13 weeks | pain intensiy on 0-10 numerical rating scale |
| Effects of rTMS vs sham on sleep | Baseline then each follow up visit at the pain center for up to 13 weeks | Sleep assessed using the sleep scale from the Medical Outcome Survey |
| Effects of rTMS vs sham on pain right now from Brief Pain Inventory | Baseline then each follow up visit at the pain center for up to 13 weeks | pain intensiy on 0-10 numerical rating scale |
| Effects on Global Impression of change assessed by the clinician | 13 weeks (end of the treatment) | Clinician global impression of change (from much improved to much deteriorated) |
Countries
France
Contacts
CONTACTNadine ATTAL
STUDY_DIRECTORNadine ATTAL
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed