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

Primary Purpose

Radiculopathy, Lower Extremity Radicular Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quantitative Sensory Testing (QST)
Epidural Steroid Injection (ESI)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Radiculopathy focused on measuring Radicular, Pain, Epidural Steroid Injection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MGH Center for Translational Pain Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

>30% Pain Relief

<30% Pain Relief

Arm Description

All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.

All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2014
Last Updated
February 7, 2018
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02130258
Brief Title
Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome
Official Title
Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy, Lower Extremity Radicular Pain
Keywords
Radicular, Pain, Epidural Steroid Injection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
>30% Pain Relief
Arm Type
Other
Arm Description
All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received greater than 30% pain relief.
Arm Title
<30% Pain Relief
Arm Type
Other
Arm Description
All subjects have radicular pain and are scheduled to receive an epidural steroid injection (ESI) as a treatment. The ESI treatment is conducted by the subject's clinical physician and is not given as part of the research study procedures. Quantitative Sensory Testing (QST) will be conducted before and after the ESI treatment. QST consists of hot and cold temperature testing using the QST device. This group of subjects received less than 30% pain relief.
Intervention Type
Device
Intervention Name(s)
Quantitative Sensory Testing (QST)
Intervention Description
Subjects will undergo hot and cold temperature testing using the QST device at two points: 1) Before ESI and 2) after ESI.
Intervention Type
Procedure
Intervention Name(s)
Epidural Steroid Injection (ESI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results
Description
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.
Time Frame
Baseline measurement before the epidural injection
Title
Post-epidural Continued Pain Modulation (CPM)
Description
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.
Time Frame
4 weeks after the epidural injection
Title
Post-epidural Cold Pain Threshold QST Results
Description
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.
Time Frame
4 weeks after the epidural injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Zhang, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH Center for Translational Pain Research
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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