Fibromyalgia (FM)NCT02146495
Targeted Limbic Self-modulation as a Potential Treatment for Patients Suffering From Fibromyalgia
A study testing Simultaneous EEG and fMRI recordings and Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Trial in people with Fibromyalgia (FM), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The goal of this study is to test whether voluntary regulation of limbic system activation is possible in patients with fibromyalgia and to examine the neurobehavioral effects of specific neuromodulation of this circuit on somatosensory, limbic, and cognitive processes. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- Simultaneous EEG and fMRI recordings and Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Trial
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Aug 2022
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-55
- Fibromyalgia diagnosis by a specialist in internal medicine, Neurology or Pain medicine
- Subjective complaints about sleep disorder
- Pain does not stop despite regular medication- at least three events per week of pain ranked five out of ten
- chronic drug treatment should not be change in the near future (6 weeks).
- Hebrew speaker
- Accepted criteria for MRI scan for medical use will be followed, according to the procedures prescribed in the MRI institute of the Tel-Aviv Sourasky medical center.
Who cannot join
- Non-Hebrew speakers
- Diagnosis of another pain chronic syndrome or any significant medical illness.
- History of psychiatric or neurological diseases requiring hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanistic Perspective on EEG Based Amygdala Driven NF in Fibromyalgia
The goal of this study is to test whether voluntary regulation of limbic system activation is possible in patients with fibromyalgia and to examine the neurobehavioral effects of specific neuromodulation of this circuit on somatosensory, limbic, and cognitive processes. This goal will be achieved by using a method previously developed for the construction of an fMRI-enriched EEG model ("EEG-Finger-Print", EFP) that selectively targets the amygdala BOLD activation (Amyg-EFP). The investigators conducted two studies: In the first study, the investigators conducted simultaneous recordings of EEG and fMRI during Amyg-EFP NF training on patients with FM. The main objective is to demonstrate target engagement following Amyg-EFP-NF training in FM patients. In the second study, the investigators aim to conduct a randomized clinical trial to examine the causal effect of the Amyg-EFP NF trial. The investigators will compare neurobehavioral effects between three groups. I. Amyg-EFP-NF group: a multisession NF trial using the Amyg-EFP model. II. Control group 1- sham-NF: a multisession NF trial using sham feedback. III. Control group 2: patients in this group will continue their usual treatment without intervention.
Read the detailed description
The current study aims to focus on the neural mechanism and brain-guided therapy of Fibromyalgia (FM); a chronic pain syndrome. Despite intense investigations, the pathophysiology of fibromyalgia remains elusive. Several studies demonstrated that morphological and functional changes in the central nervous system may play an important role in FM development and progression. The unknown etiopathology of FM contributed greatly to the absence of mechanism-specific cures. The insufficient treatment for FM, along with the understanding that CNS abnormality constitutes a major factor in FM pathophysiology, emphasizes the need for mechanism-based therapeutic intervention and opens the door for advanced neuromodulation techniques. Guided by this approach, the investigators aspired to establish a multi-function model with the potential to exert neuromodulation effects. To address this goal, the investigators employ a method previously developed for the construction of an fMRI-enriched EEG model ("EEG-Finger-Print", EFP). In this approach, EEG is used to predict specific brain activity, as measured by fMRI in a given region. Our main objective is to explore the neural mechanisms that underlie limbic neuromodulation and to gain a profound understanding of the functional processes that can potentially modify deficient functions in FM. The investigators intend to conduct two studies. In the first study, the investigators focus on the previously developed EFP model that selectively targets the amygdala BOLD activation (Amyg-EFP). The investigators aspired to investigate Amyg-EFP-NF effects on chronic pain in FM. To do so, the investigators conducted simultaneous recordings of EEG and fMRI during Amyg-EFP NF training on patients with FM. The main research objective of this study is to demonstrate target engagement following Amyg-EFP-NF training in FM patients. In the second study, the investigators aim to conduct a randomized clinical trial to examine the causal effect of the Amyg-EFP on patients with FM and to explore the clinical effect of this model on a wide range of symptoms related to FM. To examine the neural, clinical, and behavioral specific effects of the EFP-NF training, the investigators will implement a comprehensive clinical assessment. Furthermore, the investigators will conduct an MRI/fMRI scan before and after the EFP-NF trial, in order to explore the neural modification effects. Clinical follow-up will be conducted after 10-12 months from the post-intervention evaluation. The investigators will compare the neural, clinical, and behavioral effects between three groups. I. Amyg-EFP-NF group: a multisession NF trial using feedback driven by the Amyg-EFP model. II. Control group I- sham-NF: a multisession NF trial using sham feedback. III. Control group II: patients in this group will continue their usual treatment without any intervention. The investigators hypothesize that patients in the Amyg -EFP-NF group will exhibit wider and more robust changes in neural and behavioral outcomes associated with the wide range of symptoms related to FM. This study can significantly advance the understanding of the neural processes that mediate modification of somatic-affective functions in patients with FM and, therefore, enable the establishment of better treatment prediction and possibly more personalized procedures in future studies.
- Conditions
- Fibromyalgia (FM)
- Being tested
- Simultaneous EEG and fMRI recordings, Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Trial, Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Sham Trial
- Keywords
- Fibromyalgia, neurofeedback, fMRI, EEG
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous EEG and fMRI recordingsDevice
Amygdala-Electrical Fingerprint (Amyg-EFP)-NF TrialDevice
Neurofeedback training utilizing Amygdala Electrical Fingerprint (Amyg-EFP) methodology
Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Sham TrialDevice
Sham neurofeedback training based on a randomized artificial Amyg-EFP signal.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous EEG/ fMRI Recordings during Amyg-EFP-NF | Experimental | Patients with FM will undergo concurrent EEG and fMRI recordings. During the fMRI scans, they will engage in Amyg-EFP NF training. Receives: Device: Simultaneous EEG and fMRI recordings |
| Amyg-EFP-NF Trial | Active comparator | The EFP-NF procedure will include a multisession NF trial (10 sessions) using feedback driven by the Amyg-EFP model. Receives: Device: Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Trial |
| Amyg-EFP-NF Sham Trial | Sham comparator | The sham NF procedure will include a multisession NF trial (10 sessions) using sham feedback; in this condition, the feedback will be provided based on a randomized Amyg-EFP signal. Receives: Device: Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Sham Trial |
| Treatment As Usual | No intervention | Patients in this group will continue their usual treatment without any intervention. Patients in this control group will undergo a complete clinical and neural evaluation at the beginning and end of a defined period, similar to the NF intervention period, and a clinical follow-up (after 10-12 months). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement using the Fibromyalgia Impact Questionnaire (FIQ) to evaluate FM symptoms
Scoring from 0 (no impairment) to 80 (maximum), with subscales ranging up to 10 (maximum).
Measured: Immediately post-intervention relative to the baseline level
Clinical improvement using the Symptom Severity Score (SSS)
Ranges from 0 to 12 (highest severity).
Measured: Immediately post-intervention relative to the baseline level
Clinical improvement using the Widespread Pain Index (WPI)
Ranges from 0 to 19 (highest level of pain distribution).
Measured: Immediately post-intervention relative to the baseline level
Clinical improvement using the SF-36 Health Survey (SF-36) to evaluate daily impacts of FM
Scores from 0 to 100 (higher scores indicate better health).
Measured: Immediately post-intervention relative to the baseline level
Clinical improvement using the Trait Anxiety Inventory (STAI-T) to evaluate the level of anxiety
Ranges from 20 to 80 (highest anxiety level).
Measured: Immediately post-intervention relative to the baseline level
Clinical improvement using the Beck Depression Inventory (BDI) to evaluate the level of depression
Ranges from 0 to 63 (highest depression level).
Measured: Immediately post-intervention relative to the baseline level
Long-term clinical improvement using the Fibromyalgia Impact Questionnaire (FIQ) to evaluate FM symptoms
Scoring from 0 (no impairment) to 80 (maximum), with subscales ranging up to 10 (maximum).
Measured: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Long-term clinical improvement using the Symptom Severity Score (SSS)
Ranges from 0 to 12 (highest severity).
Measured: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Long-term clinical improvement using the Widespread Pain Index (WPI)
Ranges from 0 to 19 (highest level of pain distribution).
Measured: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Long-term clinical improvement using the SF-36 Health Survey (SF-36) to evaluate daily impacts of FM
Scores from 0 to 100 (higher scores indicate better health).
Measured: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Long-term clinical improvement using the Trait Anxiety Inventory (STAI-T) to evaluate the level of anxiety
Ranges from 20 to 80 (highest anxiety level).
Measured: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Long-term clinical improvement using the Beck Depression Inventory (BDI) to evaluate the level of depression
Ranges from 0 to 63 (highest depression level).
Measured: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Secondary outcomes (1)
Neural Prediction
Simultaneous fMRI/EEG scan in order to identify whether the Amyg-EFP signal reliably predicts the amygdala BOLD activity
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJan 2017
- Primary completionAug 2022
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ayelet Or-Borichev, PhD, Principal investigator, Sagol Brain Institute, Tel Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146495
- Sponsor's protocol ID
- TASMC-14-HS-0044-CTIL
- Status last verified
- Feb 2024
- First submitted
- 21 May 2014
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Or-Borichev A, Lerner Y, Hamrani Y, Gurevitch G, Mor N, Doron M, Sarna N, Ablin JN, Hendler T, Sharon H. Targeted limbic self-neuromodulation for alleviating central sensitization symptoms in fibromyalgia. BMC Med. 2025 May 28;23(1):304. doi: 10.1186/s12916-025-04138-3.
PubMed 40437546
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Perspective on EEG Based Amygdala Driven NF in Fibromyalgia
- ClinicalTrials.gov ID
- NCT02146495
- Acronym / sponsor ID
- TASMC-14-HS-0044-CTIL
- Conditions
- Fibromyalgia (FM)
- Keywords
- Fibromyalgia, neurofeedback, fMRI, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2017 (actual)
- Primary completion
- Aug 2022 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 23 May 2014 (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.
The goal of this study is to test whether voluntary regulation of limbic system activation is possible in patients with fibromyalgia and to examine the neurobehavioral effects of specific neuromodulation of this circuit on somatosensory, limbic, and cognitive processes. This goal will be achieved by using a method previously developed for the construction of an fMRI-enriched EEG model ("EEG-Finger-Print", EFP) that selectively targets the amygdala BOLD activation (Amyg-EFP). The investigators conducted two studies: In the first study, the investigators conducted simultaneous recordings of EEG and fMRI during Amyg-EFP NF training on patients with FM. The main objective is to demonstrate target engagement following Amyg-EFP-NF training in FM patients. In the second study, the investigators aim to conduct a randomized clinical trial to examine the causal effect of the Amyg-EFP NF trial. The investigators will compare neurobehavioral effects between three groups. I. Amyg-EFP-NF group: a multisession NF trial using the Amyg-EFP model. II. Control group 1- sham-NF: a multisession NF trial using sham feedback. III. Control group 2: patients in this group will continue their usual treatment without intervention.
Detailed description
The current study aims to focus on the neural mechanism and brain-guided therapy of Fibromyalgia (FM); a chronic pain syndrome. Despite intense investigations, the pathophysiology of fibromyalgia remains elusive. Several studies demonstrated that morphological and functional changes in the central nervous system may play an important role in FM development and progression. The unknown etiopathology of FM contributed greatly to the absence of mechanism-specific cures. The insufficient treatment for FM, along with the understanding that CNS abnormality constitutes a major factor in FM pathophysiology, emphasizes the need for mechanism-based therapeutic intervention and opens the door for advanced neuromodulation techniques. Guided by this approach, the investigators aspired to establish a multi-function model with the potential to exert neuromodulation effects. To address this goal, the investigators employ a method previously developed for the construction of an fMRI-enriched EEG model ("EEG-Finger-Print", EFP). In this approach, EEG is used to predict specific brain activity, as measured by fMRI in a given region. Our main objective is to explore the neural mechanisms that underlie limbic neuromodulation and to gain a profound understanding of the functional processes that can potentially modify deficient functions in FM. The investigators intend to conduct two studies. In the first study, the investigators focus on the previously developed EFP model that selectively targets the amygdala BOLD activation (Amyg-EFP). The investigators aspired to investigate Amyg-EFP-NF effects on chronic pain in FM. To do so, the investigators conducted simultaneous recordings of EEG and fMRI during Amyg-EFP NF training on patients with FM. The main research objective of this study is to demonstrate target engagement following Amyg-EFP-NF training in FM patients. In the second study, the investigators aim to conduct a randomized clinical trial to examine the causal effect of the Amyg-EFP on patients with FM and to explore the clinical effect of this model on a wide range of symptoms related to FM. To examine the neural, clinical, and behavioral specific effects of the EFP-NF training, the investigators will implement a comprehensive clinical assessment. Furthermore, the investigators will conduct an MRI/fMRI scan before and after the EFP-NF trial, in order to explore the neural modification effects. Clinical follow-up will be conducted after 10-12 months from the post-intervention evaluation. The investigators will compare the neural, clinical, and behavioral effects between three groups. I. Amyg-EFP-NF group: a multisession NF trial using feedback driven by the Amyg-EFP model. II. Control group I- sham-NF: a multisession NF trial using sham feedback. III. Control group II: patients in this group will continue their usual treatment without any intervention. The investigators hypothesize that patients in the Amyg -EFP-NF group will exhibit wider and more robust changes in neural and behavioral outcomes associated with the wide range of symptoms related to FM. This study can significantly advance the understanding of the neural processes that mediate modification of somatic-affective functions in patients with FM and, therefore, enable the establishment of better treatment prediction and possibly more personalized procedures in future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Simultaneous EEG/ fMRI Recordings during Amyg-EFP-NF | Experimental | Device: Simultaneous EEG and fMRI recordingsPatients with FM will undergo concurrent EEG and fMRI recordings. During the fMRI scans, they will engage in Amyg-EFP NF training. |
| Amyg-EFP-NF Trial | Active comparator | Device: Amygdala-Electrical Fingerprint (Amyg-EFP)-NF TrialThe EFP-NF procedure will include a multisession NF trial (10 sessions) using feedback driven by the Amyg-EFP model. |
| Amyg-EFP-NF Sham Trial | Sham comparator | Device: Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Sham TrialThe sham NF procedure will include a multisession NF trial (10 sessions) using sham feedback; in this condition, the feedback will be provided based on a randomized Amyg-EFP signal. |
| Treatment As Usual | No intervention | –Patients in this group will continue their usual treatment without any intervention. Patients in this control group will undergo a complete clinical and neural evaluation at the beginning and end of a defined period, similar to the NF intervention period, and a clinical follow-up (after 10-12 months). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 18-55
- Fibromyalgia diagnosis by a specialist in internal medicine, Neurology or Pain medicine
- Subjective complaints about sleep disorder
- Pain does not stop despite regular medication- at least three events per week of pain ranked five out of ten
- chronic drug treatment should not be change in the near future (6 weeks).
Key exclusion criteria (3 listed)
- Non-Hebrew speakers
- Diagnosis of another pain chronic syndrome or any significant medical illness.
- History of psychiatric or neurological diseases requiring hospitalization.
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 |
|---|---|---|
| Simultaneous EEG and fMRI recordings | Device | Simultaneous EEG/ fMRI Recordings during Amyg-EFP-NF |
| Amygdala-Electrical Fingerprint (Amyg-EFP)-NF TrialNeurofeedback training utilizing Amygdala Electrical Fingerprint (Amyg-EFP) methodology | Device | Amyg-EFP-NF Trial |
| Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Sham TrialSham neurofeedback training based on a randomized artificial Amyg-EFP signal. | Device | Amyg-EFP-NF Sham Trial |
Primary outcome
Clinical improvement using the Fibromyalgia Impact Questionnaire (FIQ) to evaluate FM symptoms
Time frame: Immediately post-intervention relative to the baseline level
Scoring from 0 (no impairment) to 80 (maximum), with subscales ranging up to 10 (maximum).
Clinical improvement using the Symptom Severity Score (SSS)
Time frame: Immediately post-intervention relative to the baseline level
Ranges from 0 to 12 (highest severity).
Clinical improvement using the Widespread Pain Index (WPI)
Time frame: Immediately post-intervention relative to the baseline level
Ranges from 0 to 19 (highest level of pain distribution).
Clinical improvement using the SF-36 Health Survey (SF-36) to evaluate daily impacts of FM
Time frame: Immediately post-intervention relative to the baseline level
Scores from 0 to 100 (higher scores indicate better health).
Clinical improvement using the Trait Anxiety Inventory (STAI-T) to evaluate the level of anxiety
Time frame: Immediately post-intervention relative to the baseline level
Ranges from 20 to 80 (highest anxiety level).
Clinical improvement using the Beck Depression Inventory (BDI) to evaluate the level of depression
Time frame: Immediately post-intervention relative to the baseline level
Ranges from 0 to 63 (highest depression level).
Long-term clinical improvement using the Fibromyalgia Impact Questionnaire (FIQ) to evaluate FM symptoms
Time frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Scoring from 0 (no impairment) to 80 (maximum), with subscales ranging up to 10 (maximum).
Long-term clinical improvement using the Symptom Severity Score (SSS)
Time frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Ranges from 0 to 12 (highest severity).
Long-term clinical improvement using the Widespread Pain Index (WPI)
Time frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Ranges from 0 to 19 (highest level of pain distribution).
Long-term clinical improvement using the SF-36 Health Survey (SF-36) to evaluate daily impacts of FM
Time frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Scores from 0 to 100 (higher scores indicate better health).
Long-term clinical improvement using the Trait Anxiety Inventory (STAI-T) to evaluate the level of anxiety
Time frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Ranges from 20 to 80 (highest anxiety level).
Long-term clinical improvement using the Beck Depression Inventory (BDI) to evaluate the level of depression
Time frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
Ranges from 0 to 63 (highest depression level).
1 secondary outcome
Neural Prediction
Time frame: Through study completion, an average of 2 year
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 20 Mar 2024.
- Derived from this study: PubMed 40437546Or-Borichev A, Lerner Y, Hamrani Y, Gurevitch G, Mor N, Doron M, Sarna N, Ablin JN, Hendler T, Sharon H. Targeted limbic self-neuromodulation for alleviating central sensitization symptoms in fibromyalgia. BMC Med. 2025 May 28;23(1):304. doi: 10.1186/s12916-025-04138-3.
- Individual participant dataSharing planned: No
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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.
Ayelet Or-Borichev, PhD principal investigator
Sagol Brain Institute, Tel Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous EEG and fMRI recordings and Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Trial in people with Fibromyalgia (FM), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 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 20 Mar 2024. 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 Israel. 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.
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?
Clinical improvement using the Fibromyalgia Impact Questionnaire (FIQ) to evaluate FM symptoms (time frame: Immediately post-intervention relative to the baseline level). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02146495, which also lists 1 linked publication.
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 20 Mar 2024.