Nocebo EffectCRANENCT06103474
Clinical Reporting to Alleviate the Nocebo Effect
A study testing Lumbar Magnetic Resonance Imaging (MRI) in people with Nocebo Effect, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Terminology in radiology reports may cause patients harm by anchoring to or justifying a particular diagnosis. This phenomenon is known as the nocebo effect. MRI may cause patients to pursue more invasive procedures with little added benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nocebo Effect
- What is being tested?
- Lumbar Magnetic Resonance Imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2024to 11 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of lower back pain undergoing MRI
- Greater than 18 years of age
- Able to understand and willing to comply with all study procedures and is available for the duration of the study
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in the study:
- Acute lower back pain secondary to trauma within 1 months
- Severe cord compression on MRI
- Cord signal abnormality on MRI
- Metastatic cancer
- Spinal epidural abscess
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- Vertebral osteomyelitis
- Judgement of the ordering physician (e.g. focal neurologic deficit)
- Anything that, in the opinion of the investigator or team, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Reporting to Alleviate the Nocebo Effect (CRANE)
Terminology in radiology reports may cause patients harm by anchoring to or justifying a particular diagnosis. This phenomenon is known as the nocebo effect. MRI may cause patients to pursue more invasive procedures with little added benefit. 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.
- Conditions
- Nocebo Effect
- Being tested
- Lumbar Magnetic Resonance Imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Magnetic Resonance Imaging (MRI)Diagnostic test
Lumbar Magnetic Resonance Imaging (MRI)
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Report | Active comparator | The subject will receive standard of care imaging report. Receives: Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI) |
| Clinical Report | Active comparator | The subject will receive a technical report that avoids language that may cause catastrophizing or evoke the nocebo effect. Receives: Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.
Measured: 6 weeks post intervention
Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.
Measured: within 7 days post intervention
Secondary outcomes (1)
Improvement in pain interference measured via brief pain inventory
Measured: 6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start14 Jan 2024
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocebo EffectStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Survey, cross-sectional study of sixty (n=60) participants undergoing MRI for lower back pain will be randomized to receive an anatomic report (standard of care) versus a Clinical Report (CR). Ordering physicians receiving the Clinical Reports will be instructed to avoid terms that may result in cyberchondria or fear (e.g. disc bulge or nerve impingement) when discussing MRI results.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Roentgen Ray Society
- Responsible party
- Principal investigator, Steven A Rothenberg, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103474
- Sponsor's protocol ID
- 300010891
- Other IDs
- American Roentgen Ray Society
- Acronym
- CRANE
- Status last verified
- Jan 2026
- First submitted
- 18 Oct 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Reporting to Alleviate the Nocebo Effect (CRANE)
- ClinicalTrials.gov ID
- NCT06103474
- Acronym / sponsor ID
- CRANE / 300010891
- Conditions
- Nocebo Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Roentgen Ray Society
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 26 Oct 2023 (actual)
- 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.
Terminology in radiology reports may cause patients harm by anchoring to or justifying a particular diagnosis. This phenomenon is known as the nocebo effect. MRI may cause patients to pursue more invasive procedures with little added benefit. 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Survey, cross-sectional study of sixty (n=60) participants undergoing MRI for lower back pain will be randomized to receive an anatomic report (standard of care) versus a Clinical Report (CR). Ordering physicians receiving the Clinical Reports will be instructed to avoid terms that may result in cyberchondria or fear (e.g. disc bulge or nerve impingement) when discussing MRI results.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Report | Active comparator | Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)The subject will receive standard of care imaging report. |
| Clinical Report | Active comparator | Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)The subject will receive a technical report that avoids language that may cause catastrophizing or evoke the nocebo effect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of lower back pain undergoing MRI
- Greater than 18 years of age
- Able to understand and willing to comply with all study procedures and is available for the duration of the study
Key exclusion criteria (9 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in the study:
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 |
|---|---|---|
| Lumbar Magnetic Resonance Imaging (MRI)Lumbar Magnetic Resonance Imaging (MRI) | Diagnostic test | Clinical Report, Standard of Care Report |
Primary outcome
Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.
Time frame: 6 weeks post intervention
Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.
Time frame: within 7 days post intervention
1 secondary outcome
Improvement in pain interference measured via brief pain inventory
Time frame: 6 weeks post intervention
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 29 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Magnetic Resonance Imaging (MRI) in people with Nocebo Effect, run by University of Alabama at Birmingham at 1 site in United States.
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 3 inclusion and 9 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 29 Jul 2026. 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 United States. 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. 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?
Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort. (time frame: 6 weeks post intervention). The study lists 2 primary outcomes in all. 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 29 Jul 2026.