FibromyalgiaPhase 3NCT00374673
Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders
A Phase 3 study testing Repetitive transcranial magnetic stimulation in people with Fibromyalgia and Irritable Bowel Syndrome, run by Hospital Ambroise Paré Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibromyalgia, Irritable Bowel Syndrome, Burning Mouth Syndrome
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain related to Fibromyalgia (ACR criteria) or IBS (Rome II criteria) or burning mouth syndrome (IHS criteria 2004)
- Chronic pain for at least 6 months
- Pain for at least 4 days a week
- Mean average pain score at inclusion and randomization ≥ 4/10 (numerical scale)
- Patients aged 18 years and less than 80 years
- Informed consent
- Stable antalgic treatment
Who cannot join
- Contraindications to TMS (electroconvulsive therapy, epilepsy, head trauma, intracranial hypertension, metallic clip, pace maker, pregnancy)
- Major depression (DSM IV criteria) or psychosis
- Disorder preventing an accurate understanding of the testing and protocol
- Intermittent pain
- Pain for less than 6 months
- Other pain more severe than the pain evaluated for the trial
- Alcohol/psychoactive drugs abuse
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Repetitive transcranial magnetic stimulation
- Keywords
- TMS, chronic pain, fibromyalgia, IBS, burning mouth syndrome, predictive factors
- Medical subject headings
- Fibromyalgia, Irritable Bowel Syndrome, Burning Mouth Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
Also called placebo stimulation, rTMS
Repetitive transcranial magnetic stimulation of the motor cortex (10 Hz) every day during 5 days then every week for 3 weeks then every two weeks for 2 months then every month for 3 additional months
| Study group | Role | What they receive |
|---|---|---|
| transcranial magnetic stimulation | Experimental | repetitive transcranial magnetic stimulation of the motor cortex Receives: Device: Repetitive transcranial magnetic stimulation |
| placebo stimulation | Sham comparator | repetitive placebo stimulation of the motor cortex Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain over the last 24 hours at each visit -pain diary at baseline to see the stability of the measures
Brief Pain inventory
Measured: at each visit before the stimulation session
Secondary outcomes (9)
Sensory and affective pain scores (McGill pain questionnaire)
Short form MPQ was used
Measured: at baseline, then day 1, 5, weeks 3, 9, and 25 after the induction phase
Quality of life (brief pain inventory)
Brief Pain inventory (Cleeland and Ryan 1992) interference items (7)
Measured: at baseline, days 1, 5,weeks 3, 9, and 25 after the induction phase
Disability ( FIQ)
FIQ only for fibromyalgia patients
Measured: at days 1, 5, weeks 3, 9 and 25 after the induction phase
Comorbidities (HAD)
21 item Hospital anxiety and depression scale
Measured: at week 3 7, 13, 25 after the induction phase
Catastrophizing (PCS)
Pain Catastrophizing Scale (Sullivan et al 1995)
Measured: at weeks 3, 7, 13 and 25 after the induction phase
Predictors of the response based on psychological factors and measures of cortical excitability
Measured: at inclusion
Safety including cognitive evaluation
Cognitive tests were performed by a neuropsychologists and included measures of attention and memory
Measured: at 6 months (cognitive evaluation) ; safety assessed every month for up to 12 months
Comparison of the efficacy of TMS between 3 different pain disorders
this can only be made when the two other groups of patients will have finished the enrollment - for now the study on fibromyalgia is finished and results analysed - the other groups are still being recruited (ie, IBS, burning mouth syndrome)
Measured: during the whole study period -ie, days 1, 5, then before each stimulation throughout the study
assessment of cortical excitability
determination of rest motor threshold, suprathreshold motor evoiked potentials (MEP), SICI and ICF, for the left hemisphere
Measured: day 1, 5, weeks 3, 9 and 21 after the induction phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine ATTAL, Hospital Ambroise Paré Paris
- Investigators
- Nadine ATTAL, MD, PhD, Principal investigator, INSERM U 987 and AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374673
- Sponsor's protocol ID
- TMS-chronic pain 1
- Status last verified
- Dec 2015
- First submitted
- 8 Sep 2006
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Idiopathic Pain Syndromes : a Double Blind Sham Controlled Study
- ClinicalTrials.gov ID
- NCT00374673
- Acronym / sponsor ID
- TMS-chronic pain 1
- Keywords
- TMS, chronic pain, fibromyalgia, IBS, burning mouth syndrome, predictive factors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial magnetic stimulation | Experimental | Device: Repetitive transcranial magnetic stimulationrepetitive transcranial magnetic stimulation of the motor cortex |
| placebo stimulation | Sham comparator | Device: Repetitive transcranial magnetic stimulationrepetitive placebo stimulation of the motor cortex |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pain related to Fibromyalgia (ACR criteria) or IBS (Rome II criteria) or burning mouth syndrome (IHS criteria 2004)
- Chronic pain for at least 6 months
- Pain for at least 4 days a week
- Mean average pain score at inclusion and randomization ≥ 4/10 (numerical scale)
- Patients aged 18 years and less than 80 years
Key exclusion criteria (7 listed)
- Contraindications to TMS (electroconvulsive therapy, epilepsy, head trauma, intracranial hypertension, metallic clip, pace maker, pregnancy)
- Major depression (DSM IV criteria) or psychosis
- Disorder preventing an accurate understanding of the testing and protocol
- Intermittent pain
- Pain for less than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulationAlso: placebo stimulation, rTMSRepetitive transcranial magnetic stimulation of the motor cortex (10 Hz) every day during 5 days then every week for 3 weeks then every two weeks for 2 months then every month for 3 additional months | Device | placebo stimulation, transcranial magnetic stimulation |
Primary outcome
Average pain over the last 24 hours at each visit -pain diary at baseline to see the stability of the measures
Time frame: at each visit before the stimulation session
Brief Pain inventory
9 secondary outcomes
Sensory and affective pain scores (McGill pain questionnaire)
Time frame: at baseline, then day 1, 5, weeks 3, 9, and 25 after the induction phase
Quality of life (brief pain inventory)
Time frame: at baseline, days 1, 5,weeks 3, 9, and 25 after the induction phase
Disability ( FIQ)
Time frame: at days 1, 5, weeks 3, 9 and 25 after the induction phase
Comorbidities (HAD)
Time frame: at week 3 7, 13, 25 after the induction phase
Catastrophizing (PCS)
Time frame: at weeks 3, 7, 13 and 25 after the induction phase
Predictors of the response based on psychological factors and measures of cortical excitability
Time frame: at inclusion
Safety including cognitive evaluation
Time frame: at 6 months (cognitive evaluation) ; safety assessed every month for up to 12 months
Comparison of the efficacy of TMS between 3 different pain disorders
Time frame: during the whole study period -ie, days 1, 5, then before each stimulation throughout the study
assessment of cortical excitability
Time frame: day 1, 5, weeks 3, 9 and 21 after the induction phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine ATTAL, MD, PhD principal investigator
INSERM U 987 and AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Repetitive transcranial magnetic stimulation in people with Fibromyalgia and Irritable Bowel Syndrome, run by Hospital Ambroise Paré Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain over the last 24 hours at each visit -pain diary at baseline to see the stability of the measures (time frame: at each visit before the stimulation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.