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

Recruiting

• Conditions: Chronic pain; 10043237

• Registration Number: NL-OMON54240
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 200

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

- 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain reduction on an NRS scale between patients receiving standard clinical<br /><br>care versus patients receiving additional 18F-FDG PET/MRI guided treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>na</p><br>