My spine is on fire: neuroinflammation in spinal radiculopathy and physiotherapy on it.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Cervical radiculopathy patients
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 patient.
• Referral by a medical specialist
• High and mixed affinity binders for second generation TSPO radiotracers
• Evident [11C]-DPA713 binding in the neuroforamina and/or spinal cord. Only
applicable for research question 2 and 3.

Healthy control
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 healthy control.
Referral by a medical specialist
• High and mixed affinity binders for second generation TSPO radiotracers

Exclusion Criteria

Cervical radiculopathy patients and healthy control
A potential participant 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
<p>1) [11C]-R-DPA713 BPnd in the spinal cord and neuroforamina</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2) Δ [11C]-R-DPA713 BPnd in the spinal cord and neuroforamina between a) joint-<br /><br>and neural mobilisations and b) therapeutic exercise, compared to c) a soft<br /><br>collar<br /><br>3) Intraclass correlation coefficient (ICC2.1), Standard Error of Measurement<br /><br>(SEM) and Smallest Detectable Change (SDC) </p><br>