Overview

This trial is active, not recruiting.

Conditions radiculopathy, lower extremity radicular pain
Treatment quantitative sensory testing (qst)
Sponsor Massachusetts General Hospital
Start date May 2012
End date December 2016
Trial size 23 participants
Trial identifier NCT02130258, 2011P002234

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Other)
The ESI treatment is conducted by the subject's clinical physician and is not a part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted pre and post ESI treatment.
quantitative sensory testing (qst)
Subjects will undergo hot and cold temperature testing using the QST device at two points: 1) Before ESI and 2) after ESI.

Primary Outcomes

Measure
Somatosensory Testing using Quantitative Sensory Testing device (QST)
time frame: 3 months

Secondary Outcomes

Measure
Visual Analog Scale for Pain (VAS)
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome
Principal investigator Yi Zhang, MD, PhD
Description The investigators are comparing warm/cold sensation, heat/cold pain threshold, heat/cold pain tolerance, wind-up, and diffuse noxious inhibitory control (DNIC) as measured by Quantitative Sensory Testing (QST) between subjects with a radicular pain condition. The investigators are comparing those who respond and those who do not respond to standard therapy (ESI) before and after the treatment.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.