MRI Reporting for Lower Back Pain

(CRANE Trial)

Overseen By Evan Hudson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Metastatic cancer, Spinal abscess, Osteomyelitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the language in MRI reports for lower back pain might influence patient decisions and emotions. The focus is on whether certain terms lead patients to seek unnecessary invasive procedures. Participants will be divided into groups, receiving either a standard report or one with carefully chosen language to alleviate the nocebo effect and reduce worry. This trial suits individuals over 18 with ongoing lower back pain who are undergoing an MRI. As an unphased trial, it offers participants the chance to contribute to enhancing communication in healthcare, potentially reducing anxiety and unnecessary procedures for future patients.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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 or your doctor.

What prior data suggests that this clinical reporting method is safe for patients with lower back pain?

Research has shown that changing how doctors write MRI reports can help reduce the nocebo effect, which occurs when negative expectations about treatment lead to worse outcomes. This study focuses on using language in reports that does not alarm patients or exaggerate their condition.

Without drugs or physical treatments involved, the safety concerns differ from other trials. The main risk lies in how information is presented, not in a medical procedure. No studies have shown that this communication method causes harm.

In similar studies, the language used in reports has not been linked to serious side effects. The goal is to provide information in a way that does not increase anxiety or lead to unnecessary procedures. Therefore, this approach is considered very safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving the way MRI results are reported for lower back pain, aiming to reduce the nocebo effect, which is when negative expectations worsen symptoms. Unlike standard imaging reports that may unintentionally use language that causes patients to worry more about their condition, the clinical reports in this trial use careful wording to avoid such negative implications. This approach could lead to better patient outcomes by reducing anxiety and catastrophizing, potentially improving the management of lower back pain without changing the actual medical treatment.

What evidence suggests that this trial's clinical reporting methods could be effective for lower back pain?

Research has shown that the language in medical reports can significantly impact patients' feelings, particularly those with back pain. This trial will compare two approaches: one group will receive a Clinical Report designed to reduce the nocebo effect by avoiding language that may lead to catastrophizing, while another group will receive a Standard of Care Report. Studies have found that negative language can trigger a "nocebo effect," where patients feel worse due to negative expectations. This effect can sometimes reduce treatment effectiveness and lead patients to pursue unnecessary surgeries. Using more neutral language in medical reports may help patients avoid this negative cycle, potentially improving pain management. Improved communication that reduces the nocebo effect has been shown to enhance patient experiences and outcomes. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can follow the study's procedures and are available throughout its duration. They must have a history of lower back pain and be undergoing an MRI. It's not for those with severe spinal issues, infections, cancer in the spine, recent trauma-related back pain, or any condition that might increase risk or affect participation.

Inclusion Criteria

I am older than 18 years.

You are capable of comprehending and consent to observing all research procedures, as well as being available for the entire span of the study.

I have had lower back pain and undergone an MRI.

Exclusion Criteria

I have an abscess in the spine.

My MRI shows severe spinal cord compression.

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a technical report designed to avoid the nocebo effect or a standard of care imaging report

6-8 weeks

Follow-up

Participants are monitored for changes in patient care and outcomes related to lower back pain

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Reporting to Alleviate the Nocebo Effect

Trial Overview The study investigates how wording in radiology reports (like those from lumbar MRIs) may influence patient perceptions and decisions—known as the nocebo effect—in individuals with lower back pain.

How Is the Trial Designed?

Group I: Clinical Report Active Control 1 Intervention

The subject will receive a technical report that avoids language that may cause catastrophizing or evoke the nocebo effect.

Group II: Standard of Care Report Active Control 1 Intervention

The subject will receive standard of care imaging report.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

American Roentgen Ray Society

Collaborator

Trials

2

Recruited

80+

Published Research Related to This Trial

A review of 27 randomized controlled trials found that brief psychological interventions can influence how patients report side effects from active medications, suggesting that managing expectations may help reduce perceived side effects.

The most effective strategy identified was omitting side-effect information, while other techniques like distraction and altering branding perceptions showed inconsistent results, indicating a need for further research to refine these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influencing Side-Effects to Medicinal Treatments: A Systematic Review of Brief Psychological Interventions. Webster, RK., Rubin, GJ.[2020]

The placebo effect can significantly relieve pain and improve affective disorders, indicating that inert medications can have real therapeutic benefits for patients.

Despite its potential, the placebo effect is often underutilized in clinical practice and inadequately assessed in clinical trials, highlighting the need for greater recognition and understanding of its mechanisms and impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A guide to the pharmacology of placebos. Gowdey, CW.[2022]

In a systematic review of 100 trials involving multiple sclerosis treatments, the incidence of nocebo responses was significantly higher in disease-modifying treatments (74.4%) compared to symptomatic treatments (25.3%), indicating that patients in DMT trials are more likely to experience adverse effects from placebo.

The severity of nocebo responses was similar for both treatment types, but it was found to be higher in phase II studies compared to phase III studies, suggesting that trial design and phase may influence the perception of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nocebo effects in multiple sclerosis trials: a meta-analysis. Papadopoulos, D., Mitsikostas, DD.[2022]

Nocebo effects, which can cause side effects from treatments due to negative expectations or previous experiences, are significant and can be triggered by how risk information is communicated to patients, as shown in various studies including those in neurology and psychiatry.

Effective communication about risks, including balancing it with positive treatment aspects and fostering a trusting doctor-patient relationship, can help mitigate nocebo effects and improve patient outcomes, highlighting the importance of informed consent in medical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nocebo, informed consent and doctor-patient communication]. Hansen, E., Zech, N., Benson, S.[2020]

The nocebo effect, which is the expectation of negative outcomes, has been largely overlooked in research, leading to ethical and epistemic confusions about its impact on patients.

To accurately measure the nocebo effect, researchers should use control groups of untreated patients, and ethical informed consent should consider the potential harm from how information about risks is communicated, not just the risks themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unethical informed consent caused by overlooking poorly measured nocebo effects. Howick, J.[2021]

The placebo effect is a real phenomenon confirmed by cerebral imaging studies, involving conditioned reflexes and reward anticipation, and can significantly influence treatment outcomes, especially in rheumatology.

Anxiety can weaken the placebo response, potentially due to the release of cholecystokinin, highlighting the importance of patient beliefs and effective blinding in clinical studies to accurately assess treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in rheumatology: new data. Berthelot, JM.[2020]

The placebo effect is linked to the brain's dopaminergic reward systems and is influenced by patients' expectations of treatment benefits, suggesting a biological basis for this phenomenon.

Evidence indicates that the placebo effect can be observed in various conditions, including Parkinson's disease, depression, and pain, highlighting its potential role in treatment strategies, even in long-term addiction recovery programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in neurological disorders. de la Fuente-Fernández, R., Schulzer, M., Stoessl, AJ.[2022]

A consensus among 29 leading placebo researchers suggests that enhancing placebo effects and reducing nocebo effects can improve treatment outcomes and decrease side effects in clinical practice.

The experts emphasized the need for better patient education about placebo and nocebo effects, as well as training for healthcare professionals in effective communication, to optimize these effects in medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of Placebo and Nocebo Effects for Clinical Practice: Expert Consensus. Evers, AWM., Colloca, L., Blease, C., et al.[2022]

The nocebo effect can lead to negative health outcomes due to patients' negative beliefs or expectations about treatments, which can distort the perceived effectiveness and safety of those treatments.

Healthcare professionals need to be aware of the nocebo effect, as it can arise from their explanations or patients' past experiences, and they should aim to minimize it by carefully choosing how they communicate treatment information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nocebo as a source of bias in the assessment of treatment effect. Wartolowska, K.[2020]

The systematic review analyzed 130 studies with over 8,200 participants and found that the nocebo effect has a medium magnitude (g = 0.522), indicating that negative expectations can significantly worsen symptoms in various health outcomes, particularly somatic issues.

Key factors influencing the nocebo effect include the type of health outcome and the method of induction, with larger effects observed when nocebo symptoms are induced through instructions combined with conditioning, highlighting the importance of managing patient expectations in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nocebo effect across health outcomes: A systematic review and meta-analysis. Rooney, T., Sharpe, L., Todd, J., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06103474

Clinical Reporting to Alleviate the Nocebo Effect This study aims to reproduce a study to determine the impact of clinical reporting on patient care and outcomes for those suffering from lower back pain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5639717/

Nocebo effects in clinical studies: hints for pain therapy A strong algesic nocebo effect may adversely impact a patient's condition by causing decreases in both the efficacy and effectiveness of interventions.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0753332224006127

Nocebo expectations rather than placebo ... Systematic reviews showed that in neuropathic pain trials, pain response due to placebo varies between 4 % and 44 %, while nocebo effects contribute to 52 % of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3167012/

The nocebo effect and its relevance for clinical practice Negative expectations deriving from the clinical encounter can produce negative outcomes, known as nocebo effects.

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2025.1521978/full

Optimized communication during risk disclosure to reduce ... The trial is designed to test whether optimized communication strategies aimed at minimizing nocebo effects during the informed consent procedure reduce ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11528854/

Participant's treatment guesses and adverse events in back ... To determine safety, back pain RCTs, monitor adverse events. Participants' guesses about their assigned intervention are rarely reported, and ...

7. elifesciences.org elifesciences.org/articles/105753

Nocebo effects are stronger and more persistent than ... Our data confirm that, although significant placebo and nocebo effects were found on days 1 and 8, the nocebo effect was consistently stronger.