Trial Outcomes & Findings for Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome (NCT NCT02130258)
NCT ID: NCT02130258
Last Updated: 2018-02-08
Results Overview
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.
COMPLETED
NA
23 participants
Baseline measurement before the epidural injection
2018-02-08
Participant Flow
All subjects were recruited from the MGH Center for Pain Medicine in Boston, MA.
23 subjects were initially enrolled. 3 subjects were withdrawn before assignment to groups for the following reasons: 1. sensory deficits at the site of QST and inability to complete questionnaires on own 2. did not receive ESI which is a requirement for the study
Participant milestones
| Measure |
>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.
|
<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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One subject was withdrawn before filling out questionnaires. Population description was not obtained.
Baseline characteristics by cohort
| Measure |
>30% Pain Relief
n=9 Participants
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.
|
<30% Pain Relief
n=11 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.55 years
STANDARD_DEVIATION 14.49 • n=39 Participants
|
54.44 years
STANDARD_DEVIATION 11.56 • n=41 Participants
|
56.15 years
STANDARD_DEVIATION 12.68 • n=35 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
0 Participants
n=41 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
0 Participants
n=35 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
0 Participants
n=41 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
1 Participants
n=35 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
0 Participants
n=41 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
0 Participants
n=35 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
0 Participants
n=41 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
1 Participants
n=35 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
10 Participants
n=41 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
16 Participants
n=35 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
0 Participants
n=41 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
1 Participants
n=35 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
1 Participants
n=41 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
1 Participants
n=35 Participants • One subject was withdrawn before filling out questionnaires. Population description was not obtained.
|
|
Region of Enrollment
United States
|
9 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Opioid Use
Uses opioids
|
1 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Opioid Use
Does not use opioids
|
8 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline measurement before the epidural injectionQST 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.
Outcome measures
| Measure |
>30% Pain Relief
n=9 Participants
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.
|
<30% Pain Relief
n=11 Participants
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.
|
|---|---|---|
|
Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results
|
2.68 Degrees Celsius
Standard Deviation 2.92
|
5.67 Degrees Celsius
Standard Deviation 3.22
|
PRIMARY outcome
Timeframe: 4 weeks after the epidural injectionCPM 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.
Outcome measures
| Measure |
>30% Pain Relief
n=9 Participants
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.
|
<30% Pain Relief
n=11 Participants
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.
|
|---|---|---|
|
Post-epidural Continued Pain Modulation (CPM)
|
-0.53 units on a scale
Standard Deviation 2.01
|
-4.08 units on a scale
Standard Deviation 4.67
|
PRIMARY outcome
Timeframe: 4 weeks after the epidural injectionThe 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.
Outcome measures
| Measure |
>30% Pain Relief
n=9 Participants
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.
|
<30% Pain Relief
n=11 Participants
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.
|
|---|---|---|
|
Post-epidural Cold Pain Threshold QST Results
|
-0.60 Degrees Celsius
Standard Deviation 4.10
|
-7.35 Degrees Celsius
Standard Deviation 9.11
|
Adverse Events
>30% Pain Relief
<30% Pain Relief
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place