- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02130258
Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome
February 7, 2018 updated by: Yi Zhang, MD, Massachusetts General Hospital
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- MGH Center for Translational Pain Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: >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 greater than 30% pain relief.
|
Subjects will undergo hot and cold temperature testing using the QST device at two points: 1) Before ESI and 2) after 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.
|
Other: <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.
|
Subjects will undergo hot and cold temperature testing using the QST device at two points: 1) Before ESI and 2) after 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results
Time Frame: Baseline measurement before the epidural injection
|
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
|
Post-epidural Continued Pain Modulation (CPM)
Time Frame: 4 weeks after the epidural injection
|
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
|
Post-epidural Cold Pain Threshold QST Results
Time Frame: 4 weeks after the epidural injection
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yi Zhang, MD, PhD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
April 24, 2014
First Submitted That Met QC Criteria
May 1, 2014
First Posted (Estimate)
May 5, 2014
Study Record Updates
Last Update Posted (Actual)
February 8, 2018
Last Update Submitted That Met QC Criteria
February 7, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011P002234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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