Status and phase
Conditions
Treatments
About
Chronic pain can result from injured or inflamed nerves, as occurs in people suffering from sciatica and CRPS. These nerve injuries or regions of nerve irritation are often the cause of pain in these conditions, but the current diagnostic tools are limited in pinpointing the area of origin. Several studies have implicated involvement of sigma-1 receptors in the generation and perpetuation of chronic pain conditions, others are investigating anti sigma-1 receptor drugs for the treatment of chronic pain. Using the sigma-1 receptor (S1R) detector and experimental radiotracer [18F]FTC-146 and positron emission tomography/magnetic resonance imaging (PET/MRI) scanner, the researchers may potentially identify the source of pain generation in patients suffering from complex regional pain syndrome (CRPS) and chronic sciatica. The ultimate goal is to assist in the optimization of pain treatment regimens using an [18F]FTC-146 PET/MRI scan.
The study is not designed to induce any physiological/pharmacological effect.
Full description
Participants are either pain free (control) or will be recruited based on established criteria for sciatica or CRPS. A signed consent will be obtained from willing participants.
For the PET/MRI scan, the participants will be injected with [18F]FTC-146 intravenously. After injection, simultaneous PET and MRI scans will be acquired using a hybrid PET/MRI scanner. Throughout scanning, participants will be monitored for blood pressure, temperature, heart rate and pulse oximetry. Participants will be asked to void their bladder as frequently as they can to reduce radiation exposure. Following the scan, participants will be contacted to check for adverse drug events, and any events will be recorded in the case report.
Evidence in the literature points strongly toward an involvement of S1 receptors in nervous system inflammation, which is known to be an important biologic disease/disorder mechanism for maintenance and perpetuation of chronic pain.
The main purpose of this research study is to image and identify activated pain pathways in human subjects using [18F]FTC-146 PET/MRI.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
General:
Sciatica:
CRPS:
Disease duration of 6 months or longer
Continuing pain, which is disproportionate to any inciting event
Must report at least one symptom in three of the four following categories:
Must display at least one sign at time of evaluation In two or more of the following categories:
There is no other diagnosis that better explains the signs and symptoms
For research purposes, diagnostic decision rule will be at least one symptom in all four symptom categories and at least one sign (observed at evaluation) in two or more sign categories.
The above inclusion criteria can be met OR individuals who have been determined to have a very high clinical suspicion of having CRPS as determined by the referring pain specialist can be included. This suspicion will be documented in the patient's medical record.
Exclusion criteria
General:
Sciatica:
Any condition that may interfere with interpretation of 18F-FTC-146 uptake in the region of the pelvis, thighs or lower spine including, but not limited to,
Spinal, hip or pelvic surgery or prosthesis
Cancer
Radiation therapy
Autoimmune disorders
Current infections
Inability to void bladder completely, such as in prostatic enlargement
Any urinary retention, such as in outlet obstruction, hydronephrosis etc.
Cauda equina syndrome
Developmental spinal deformities
Scoliosis >20 degrees
Spondylolysis
Vertebral fractures
Inflammatory spondylopathy
Prior lumbar surgery
CRPS:
Presence of current or past pulmonary, hepatic, renal disease, arthritis, hematopoietic, and neurological diseases not related to CRPS.
Primary purpose
Allocation
Interventional model
Masking
24 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal