My spine is on fire: neuroinflammation in cervical radiculopathy and physiotherapy
- Conditions
- cervical radiculopathy
- Registration Number
- NL-OMON25643
- Lead Sponsor
- VU University Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
Cervical radiculopathy
Inclusion
• Age between 30-65 years.
• Minimal score of 4 on the Numeric Pain Rating Scale (0-10).
• Cervical radiculopathy based on the clinical diagnosis confirmed by the Magnetic Resonance Imaging (MRI
through a medical specialist). The compression must be caused by a discus protrusion or herniation.
• Written informed consent of the subject.
• Referral by a medical specialist
• High and mixed affinity binders for second generation TSPO radiotracers
Healthy control group
Inclusion
• Age between 30-65 years.
• Asymptomatic for neck or shoulder pain and other musculoskeletal conditions in the past 3 months.
• Written informed consent of the subject.
Referral by a medical specialist
• High and mixed affinity binders for second generation TSPO radiotracers
Cervical radiculopathy and healthy control group
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Pregnancy or postpartum for 9 months
• Contra-indications for venipuncture (e.g. phlebitis)
• Underwent treatment for current complaints for the last 2 weeks (e.g. physiotherapy, manual therapy, general
practitioner etc.)
• Taken one of the following medications for the last 6 weeks: corticosteroids (e.g. prednisone), immunomodulatory
medication (e.g. methotrexate, infliximab etc.) and the use of botox for the last 3 months.
• Taken one of the following medication: NSAID’s (e.g. diclofenac, ibuprofen, naproxen etc.), Aspirin, Simvastatin
(29) for the last week.
• Benzodiazepine (30) use for the last six weeks.
• MRI contraindications, (e.g. claustrophobia, inability to lie still in the scanner or metal objects in or around the
body)
• Inability to undergo PET-CT with administration of radioligand [¹¹C]-R-DP713.
• Significant radiation exposure such that inclusion in this study will take the total dose >10mSv within the
preceding 12 months.
• Current participation in another clinical trial.
• Previous participation in a PET-CT study in the last 12 months.
• Having a medical disease with immune system involvement (e.g. MS, Spondylitis Ankylpoetica)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [11C]-R-DPA713 SUV
- Secondary Outcome Measures
Name Time Method delta[11C]-R-DPA713 SUV, ICC2.1, SDC