Nerve pinched in the neck
Conditions
Interventions
In the RCT patients will be treated with a) joint- and neural mobilisations, b)
therapeutic exercise, or c) a soft collar (control intervention)
Sponsors
Vrije Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) [11C]-R-DPA713 BPnd in the spinal cord and neuroforamina | — |
Secondary
| Measure | Time frame |
|---|---|
| 2) Δ [11C]-R-DPA713 BPnd in the spinal cord and neuroforamina between a) joint- and neural mobilisations and b) therapeutic exercise, compared to c) a soft collar 3) Intraclass correlation coefficient (ICC2.1), Standard Error of Measurement (SEM) and Smallest Detectable Change (SDC) | — |
Countries
Netherlands
Outcome results
None listed