N/A
Completed N=20
Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome
Radiculopathy · Lower Extremity Radicular Pain
Source: ClinicalTrials.gov NCT02130258 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results — 2.68; 5.67 Degrees Celsius — p=.04
Summary
The investigators hypothesize that there may exist different quantitative sensory profiles between radicular pain patients who respond and those who do not respond to the standard therapy of epidural steroid injections (ESI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results |
2.68; 5.67 | .04 sig |
| PRIMARY Post-epidural Continued Pain Modulation (CPM) |
-0.53; -4.08 | .04 sig |
| PRIMARY Post-epidural Cold Pain Threshold QST Results |
-0.60; -7.35 | 0.04 sig |
Eligibility Criteria
Inclusion Criteria
- diagnosis of lower extremity radicular pain regardless of specific or suspected etiologies
- scheduling an epidural steroid injection (ESI)
Exclusion Criteria
- a major psychiatric disorder requiring a recent (within one month) hospitalization, such as major depression, bipolar disorder, schizophrenia, anxiety disorder, and psychosis
- subject is taking illicit or recreational drug detected through a urine toxicology screen
- subject has had an interventional pain management procedures within the last eight weeks that may alter QST responses including neuraxial or local anesthetic block
- subject had a change in dosage of neuromodulatory pain medication (including gabapentin, pregabalin, cymbalta, amitriptyline, nortriptyline, trileptal, etc) in the past two weeks
- subject is pregnant
- subject has pending litigation involving the current pain condition being treated and studied.
Data sourced from ClinicalTrials.gov (NCT02130258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.