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The effectiveness of adding 18F-FDG PET/MRI to standard clinical care in patients with chronic low back or hip pain

The effectiveness of adding 18F-FDG PET/MRI to standard clinical care in patients with chronic low back or hip pain - 18F-FDG PET/MRI in chronic pain

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54240
Enrollment
200
Registered
2021-12-09
Start date
2022-04-02
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pain

Interventions

Injectiin MRI-contrast
Injection 18F-FDG forPET
Bloodsample collection.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age between 18 and 75 years - Persisting pain, defined as (more than 3 months) o Hip patient specific: * pain in the hip region after ipsilateral hip prosthesis more than 10 months ago * patients must report an NRS scale of 3 or higher o Low back group specific: * no improvement of symptoms after at least three months of conservative treatment according to the Dutch guidelines for non-specific low back pain (GP care (advise to stay active and pain medication) and exercise therapy) in primary care. * patients must report an NRS scale of 6 or higher * in case of prior surgery: at least 10 months ago - Eligible to undergo 18F-FDG PET/MRI - Capable to participate in the study

Exclusion criteria

Exclusion criteria: - Contra-indications for 18F-FDG PET/MRI (e.g. metallic foreign bodies, etc.) - Known renal insufficiency; - Known allergy to contrast agents - Prior spinal fusion - BMI *35 kg/m2 - Cancer - Opioid addiction - Metabolic disorders

Design outcomes

Primary

MeasureTime frame
Pain reduction on an NRS scale between patients receiving standard clinical care versus patients receiving additional 18F-FDG PET/MRI guided treatment

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)