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

Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130258
• Other study ID #: 2011P002234
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: February 7, 2018
• Start date: May 2012
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The investigators are comparing warm/cold sensation, heat/cold pain threshold, heat/cold pain tolerance, wind-up, and conditioned pain modulation (CPM) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Extremity Radicular Pain
• Radiculopathy

Intervention

Device:
• 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.

Procedure:
• Epidural Steroid Injection (ESI)
Subjects will receive an ESI by their clinical physician as part of their clinical treatment. This procedure is not given as part of the research study.

Locations

Country	Name	City	State
United States	MGH Center for Translational Pain Research	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results	QST tests for changes in spinal nerves. A small metal plate, called a thermode, is placed on the subject's arm. During the warm sensation test, the plate slowly increases in temperature.The subject will stop the test as soon as the plate feels warm. This temperature is recorded and can range from 32-53 degrees Celsius. The same test is repeated on the subject's leg that has radicular pain. The difference in temperatures from the test on the subject's arm and leg were analyzed.	Baseline measurement before the epidural injection
Primary	Post-epidural Continued Pain Modulation (CPM)	CPM is a type of QST where the thermode is placed on the subject's non painful arm. Heat stimulation (47 degrees C, 4 seconds) was delivered to the thermode 4 times and the subject rated the pain felt by the heat stimulation on a visual analog scale (VAS) of 0-10. During the second heat stimulation, the subject immersed their hand (opposite from the arm with the thermode) in 12 degree C water and then rated the pain felt by the heat on a VAS of 0-10 (10 is the worst pain a subject can imagine, 0 is no pain). The final 2 heat stimuli were delivered (without using the hand submerged in water). This same test was repeated with the thermode on the subject's leg with radicular pain. The subject placed their hand contralateral to the painful leg in the cold water during the second heat stimulation. The VAS scores from each heat stimulation were averaged for the non-painful arm and the painful leg. The difference in averages between the arm and leg were then analyzed.	4 weeks after the epidural injection
Primary	Post-epidural Cold Pain Threshold QST Results	The thermode is placed on the subject's arm. During the cold pain threshold test, the plate slowly decreases in temperature.The subject will stop the test when the plate is at their minimal tolerable temperature. This temperature is recorded and can range from 32-0 degrees Celsius. The same test is repeated on the subject's leg that has radicular pain. The difference in temperatures from the test on the subject's arm and leg were analyzed.	4 weeks after the epidural injection

External Links

•   MGH Center for Translational Pain Research