PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if the spine shows areas of inflammation using a specific type of imaging (pictures).

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

Inclusion criteria for pain subjects:

1. Subject is 18-75 years old.

2. Subject is able to give written informed consent.

3. Subject is currently diagnosed with lower extremity radicular pain regardless of specific or suspected etiologies.

4. Subject has a clear dermatomal distribution of the painful area extending to the distal lower extremities.

5. Subject reports ongoing pain intensity of 4 or greater using the visual analogue scale (VAS) during the week prior to enrollment.

Inclusion criteria for healthy subjects:

1. Subject is 18-75 years old.

2. Subject is able to give written informed consent.

3. Subject has no history of chronic back/spine pain.

Exclusion criteria for all groups:

1. Subject recently received a lumbar ESI (within 8 weeks).

2. Subject starts new NSAID medication for pain during the study.

3. Subject has predominantly axial low back pain.

4. Subject has known pain condition secondary to hip joint arthritis.

5. Subject is pregnant or breastfeeding.

6. Subject has allergy to lidocaine.

7. Subject is treated with chronic corticosteroid therapy.

8. Subject is on anticoagulation therapy (i.e. Coumadin, Plavix, or Lovenox).

9. Subject has a known bleeding disorder (i.e. hemophilia).

10. Subject has uncontrolled high blood pressure [>170/100].

11. Subject has a known heart condition.

12. Subject has known inflammatory disease (i.e. inflammatory bowel disease; ankylosing spondylitis; etc.).

13. Subject has known liver dysfunction or renal insufficiency or impaired elimination (Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs ≥ 3x ULN).

14. Subject has been hospitalized recently (within one month) for a major psychiatric disorder (i.e. major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychosis).

15. Subject has contraindications to MRI and PET scanning (i.e. presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, or claustrophobia).

16. Subject had research-related radiation exposure in the last 12 months.

17. Subject tests positive for use of illicit drugs, marijuana, or non-prescribed drugs.