Chronic Low-back Pain, Lumbar Disc Herniation, Neuropathy, Painful, Type 2 Diabetes
Conditions
Brief summary
The investigators will test the hypothesis that patients with low back pain associated with lumbar disc aberrancy will have elevated MGO-protein levels circulating in the blood that are comparable to patients with painful diabetic neuropathy.
Detailed description
This is a cross-sectional, non-interventional study conducted solely at KU Medical Center in which patients will be recruited and sorted based on the following status: 1) healthy, 2) painful diabetic neuropathy, 3) chronic low back pain as a result of non-operative lumbar aberrancy. Once recruited, subjects will undergo a venous blood draw to measure MGO-protein levels, HbA1c, blood glucose, NFL protein levels and GLO1 activity. Subjects will also complete questionnaires to better understand how MGO levels correlate with pain status.
Interventions
None listed
Sponsors
University of Kansas Medical Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed consent provided by the subject * Able to read/speak English * TYPE 2 DIABETES * All healthy inclusion criteria AND * Blood glucose levels \> 126 mg/dl * Diagnosed with neuropathy or experience painful numbness or tingling in their hands or feet * LOW BACK PAIN * All healthy inclusion criteria AND * Chronic (persistent pain lasting longer than 3 months) low back pain as a direct result of non-operative lumbar disc aberrancy (disc herniation, protrusion, or extrusion) * Aberrancy occurring within 12 months of pre-screening
Exclusion criteria
* Prisoner * Current clinically significant cardiac or neurological disease * Diagnosis of IBS, osteoarthritis, fibromyalgia, complex regional pain syndrome (CRPS), postherpetic neuralgia * Lumbar surgery due to disc aberrancy * Therapeutic spinal injections within the last 3 months (steroid, ablations, etc.) * Chronic use of steroids or non * steroidal anti-inflammatory drugs (NSAIDS) within 3 months of pre-screen * Past or present use of spinal cord stimulators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Methylglyoxal Evaluation | 12 months | Number of participants with elevated blood methylglyoxal-derived hydroimidazolone (MG-H1, nM) with chronic pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 months | Quantify blood HbA1c. |
| Blood Glucose | 12 months | Quantify non-fasting blood glucose (mg/dL). |
| Neurofilament Light | 12 months | Quantify circulating neurofilament light (NFL, pg/mL) proteins. |
| Glyoxylase 1 Activity | 12 months | Quantify glyoxylase 1 (GLO1, units) activity from blood cells. |
| Body Mass Index | 12 months | Height (cm) and weight (kg) will be combined to report body mass index (kg/m\^2). |
| Pain Status using the Brief Pain Index | 12 months | Quantify patients' pain status using the Brief Pain Index (BPI). |
| Neuropathy Status using the Michigan Neuropathy Screening Index | 12 months | Quantify patients' neuropathy status using the Michigan Neuropathy Screening Index (MNSI). |
Countries
United States
Outcome results
None listed