N/A N=20 Other

Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome

Radiculopathy · Lower Extremity Radicular Pain

Bottom Line

View on ClinicalTrials.gov: NCT02130258 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcome: Primary: Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results — 2.68; 5.67 Degrees Celsius — p=.04

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Quantitative Sensory Testing (QST) (Device); Epidural Steroid Injection (ESI) (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Dec 2016

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

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).

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.

View full record on ClinicalTrials.gov →

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.