Brain Imaging Study for Fibromyalgia

Overseen By Javeria A Hashmi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Cardiac, Respiratory, Nervous system, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why pain treatments for Fibromyalgia don't work well for everyone. Researchers will examine brain and psychological factors that might influence responses to pain medication. Participants will either receive a placebo (a harmless pill with no active medicine) or join a waitlist group to help gather data. This study could help doctors predict which treatments work best for different individuals. It seeks participants who have experienced chronic low back pain for more than six months and are comfortable completing tasks in English. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve pain management for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team for clarification.

What prior data suggests that this brain imaging study is safe for participants?

Research has shown that placebos can help people with fibromyalgia. In some studies, participants taking a placebo reported improvements in pain, tiredness, sleep quality, and physical ability. Even without active medication, a placebo can still lead to noticeable improvements.

Regarding safety, placebos are well-tolerated. Made of inactive ingredients, they don't cause side effects like real medications can. In trials, participants usually experience no negative effects from taking a placebo, making it a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the power of expectation can influence pain management in fibromyalgia, a condition typically managed with medications like antidepressants, anticonvulsants, and pain relievers. Unlike standard treatments, which directly target pain or its causes, this trial investigates the psychological aspect of pain relief by using placebos. By assessing whether the belief in taking an effective drug can reduce pain, researchers hope to uncover new insights into how the mind-body connection can be harnessed for therapeutic benefit. This could lead to more personalized treatment strategies that incorporate psychological elements alongside conventional medical approaches.

What evidence suggests that this trial's treatments could be effective for Fibromyalgia?

This trial will compare the effects of placebos with a waitlist control group in participants with fibromyalgia. Research has shown that placebos can significantly affect fibromyalgia symptoms. In several studies, people who received a placebo reported less pain, reduced fatigue, and improved sleep. This suggests that belief in a treatment can alter pain perception. Another study found that the placebo effect greatly reduced chronic back pain, a common symptom of fibromyalgia. These findings demonstrate that the mind-body connection influences how people with fibromyalgia feel and respond to treatments, even when the treatment is inactive. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with Fibromyalgia or chronic low back pain, experiencing at least moderate pain. Participants must be right-handed and comfortable with English tasks. It excludes those with certain diseases like asthma, claustrophobia, or conditions that conflict with MRI scanning such as having a pacemaker or being pregnant.

Inclusion Criteria

You are right-handed.

You are right-handed and experience chronic pain.

You are right-handed.

Exclusion Criteria

Healthy participant: Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy

You have any health issues that prevent you from having an MRI scan, like a pacemaker, metal implants, fear of small spaces, or being pregnant.

Healthy participant: History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment and by asking the participant about their comfort level and ability, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Data Collection

Data collected in cognitive, psychosocial, and brain-related domains to study treatment expectations

Varies

Clinical Data Collection

A subset of FM participants receive a placebo and another subset provides pain ratings as a control

3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebos

Trial Overview The study tests how different factors like brain activity and psychological state influence the effectiveness of pain treatments in Fibromyalgia patients. Some participants will receive a placebo disguised as real medication to assess treatment expectations and response.

How Is the Trial Designed?

Group I: Experimental: placebos Experimental Treatment 1 Intervention

Fibromyalgia participants will enter in an optional placebo trial. This phase of the study will test the clinical usefulness of the biomarkers. We will measure how expectation of starting a new treatment reduces 'clinical back pain' in each participant. Positive treatment expectations will be induced by giving them capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Back Pain. They will be requested to take two capsules four times a day and report their pain on paper forms organized as a calendar or on REDCap.

Group II: Waitlist Active Control 1 Intervention

Fibromyalgia participants will not be given any placebo and will be requested to report their pain on paper forms organized as a calendar or on REDCap.

Group III: Healthy Controls Active Control 1 Intervention

Healthy control participants will complete the main part of the study, but will not be asked to take a placebo or be placed on a waitlist.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

In a study of 70 fibromyalgia patients, the Regional Pain Score (RPS) was found to have a strong correlation with clinical assessments of treatment efficacy, indicating it is a valid tool for evaluating pain and treatment impact.

The RPS also demonstrated good discriminative power, with 75% sensitivity and 74% specificity in identifying effective treatments, making it a reliable measure for assessing treatment outcomes in fibromyalgia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of questionnaire-based response criteria of treatment efficacy in the fibromyalgia syndrome. Finckh, A., Morabia, A., Deluze, C., et al.[2019]

In a study of 37 fibromyalgia patients, longer duration of fibromyalgia pain was linked to reduced effectiveness of placebo analgesia, indicating that chronic pain may impair the body's natural pain relief mechanisms.

The findings suggest that early intervention in fibromyalgia is crucial, as patients with shorter pain duration may still benefit from endogenous pain regulation, highlighting the need to consider pain duration in placebo-controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower Placebo Responses After Long-Term Exposure to Fibromyalgia Pain. Kosek, E., Rosen, A., Carville, S., et al.[2022]

Fibromyalgia (FM) is linked to significant reductions in gray matter density in specific brain regions, such as the parahippocampal gyri and anterior cingulate cortex, which are related to pain perception and cognitive function.

There is a positive correlation between dopamine metabolism and gray matter density in FM patients, suggesting that alterations in dopamine may contribute to the brain changes observed in this disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in gray matter density in fibromyalgia: correlation with dopamine metabolism. Wood, PB., Glabus, MF., Simpson, R., et al.[2016]

In a study involving 10 female patients with fibromyalgia syndrome (FMS) and 26 healthy controls, the blink reflex was found to be normal in patients, indicating that basic reflex responses are intact despite their condition.

However, patients with FMS showed enhanced blink reflex excitability recovery and reduced prepulse inhibition, suggesting that there are functional changes in brainstem processing related to sensory gating, which may contribute to their altered perception of stimuli.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alterations in excitatory and inhibitory brainstem interneuronal circuits in fibromyalgia: evidence of brainstem dysfunction. Kofler, M., Halder, W.[2018]

Placebo treatment in randomized controlled trials for fibromyalgia significantly improved pain, fatigue, sleep quality, and physical function compared to no treatment, with a moderate effect size of 0.53.

The magnitude of the placebo effect was influenced by factors such as the strength of the active treatment, participant age, and baseline pain severity, while it decreased in studies with a higher proportion of women and longer disease duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect and its determinants in fibromyalgia: meta-analysis of randomised controlled trials. Chen, X., Zou, K., Abdullah, N., et al.[2018]

The study found that patients with fibromyalgia exhibited enhanced cortical relaxed thresholds and reduced cortical silent periods, indicating motor cortical dysfunction that affects both excitatory and inhibitory mechanisms.

The absence of facilitatory responses and reduced inhibitory responses in fibromyalgia patients suggest that their motor cortex is involved in chronic pain mechanisms, similar to those seen in rheumatoid arthritis, indicating a potential commonality in central pain processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor cortical dysfunction disclosed by single and double magnetic stimulation in patients with fibromyalgia. Salerno, A., Thomas, E., Olive, P., et al.[2022]

In a randomized controlled trial involving 27 female participants (8 with fibromyalgia and 19 healthy volunteers), examiners achieved an 80% accuracy rate in distinguishing between fibromyalgia patients, normal controls, and those simulating the condition.

Despite the high accuracy, the study revealed that about one-third of simulators were misidentified as having fibromyalgia, and one-fifth of fibromyalgia patients were misidentified as simulators, indicating challenges in accurately diagnosing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibromyalgia: can one distinguish it from simulation? An observer-blind controlled study. Khostanteen, I., Tunks, ER., Goldsmith, CH., et al.[2004]

In a review of 18 studies involving 3546 patients with fibromyalgia syndrome, a significant 18.6% of participants experienced a 50% reduction in pain from placebo treatments, highlighting the strong placebo effect in chronic pain trials.

The study also found that 10.9% of patients in placebo groups dropped out due to adverse events, indicating a notable nocebo effect, which suggests that both placebo and nocebo responses play a critical role in the perceived efficacy and safety of drug treatments for fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo and nocebo responses in randomised controlled trials of drugs applying for approval for fibromyalgia syndrome treatment: systematic review and meta-analysis. Häuser, W., Sarzi-Puttini, P., Tölle, TR., et al.[2022]

Both fibromyalgia patients and healthy controls experienced similar levels of placebo analgesia, indicating that the mechanisms of pain relief through placebo are effective in chronic pain conditions as well.

The study found that the placebo effect was not influenced by opioid pathways, as naloxone (an opioid antagonist) did not alter the analgesic response, suggesting that conditioning rather than expectation plays a key role in placebo analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural effects of placebo analgesia in fibromyalgia patients and healthy individuals. Frangos, E., Čeko, M., Wang, B., et al.[2023]

Citations

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The placebo effect and its determinants in fibromyalgia Participants who received placebo in the RCTs experienced significantly better improvements in pain, fatigue, sleep quality, physical function, and other main ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8518410/

Placebo effects in low back pain: A systematic review and ... This review shows a significant contribution of placebo effects to chronic LBP symptom relief in clinical and experimental conditions.

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Open-Label Placebo Injection for Chronic Back Pain With ... Main Outcomes and Measures The primary outcome was pain intensity (0-10, with 0 indicating no pain and 10 the most intense) at 1 month posttreatment. Secondary ...

4. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2021.750523/full

Placebo Responses and Their Clinical Implications in ... Our results provide preliminary evidence that placebo responses, which also consist of non-specific effects, might play a role in the treatment of FM.

5. nature.com nature.com/articles/s41591-025-03977-0

Full-spectrum extract from Cannabis sativa DKJ127 for ... The results of the VER-CLBP-001 trial demonstrate that VER-01 provides meaningful pain reduction compared to the placebo, accompanied by ...

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Efficacy and Safety of ASP0819 in Patients with Fibromyalgia In the current study, there was no statistically significant difference between ASP0819 and placebo for the primary endpoint, nor in the change ...

7. nature.com nature.com/articles/s41598-024-83776-8

A safety and feasibility randomized placebo controlled trial ... This study evaluates the safety, feasibility, and acceptability of a novel electroencephalography-based neurofeedback training, targeting effective alpha-band ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724608344

THU0329 Placebo Effect in Fibromyalgia – A Systematic ... Participants who took placebo in the trials had significant improvements in pain, fatigue, sleep quality, physical function, and other main outcomes.