Radiculopathy, Lower Extremity Radicular Pain
Conditions
Keywords
Radicular, Pain, Epidural Steroid Injection
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.
Interventions
Subjects will undergo hot and cold temperature testing using the QST device at two points: 1) Before ESI and 2) after ESI.
PROCEDUREEpidural 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results | 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. |
| Post-epidural Continued Pain Modulation (CPM) | 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. |
| Post-epidural Cold Pain Threshold QST Results | 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. |
Countries
United States
Participant flow
Recruitment details
All subjects were recruited from the MGH Center for Pain Medicine in Boston, MA.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| >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. | 9 |
| <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. | 11 |
| Total | 20 |
Baseline characteristics
| Characteristic | >30% Pain Relief | <30% Pain Relief | Total |
|---|---|---|---|
| Age, Continuous | 57.55 years STANDARD_DEVIATION 14.49 | 54.44 years STANDARD_DEVIATION 11.56 | 56.15 years STANDARD_DEVIATION 12.68 |
| Opioid Use Does not use opioids | 8 Participants | 5 Participants | 13 Participants |
| Opioid Use Uses opioids | 1 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 10 Participants | 16 Participants |
| Region of Enrollment United States | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 11 |
| other Total, other adverse events | 0 / 9 | 0 / 11 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 |
Outcome results
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.
Time frame: 4 weeks after the epidural injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| >30% Pain Relief | Post-epidural Cold Pain Threshold QST Results | -0.60 Degrees Celsius | Standard Deviation 4.1 |
| <30% Pain Relief | Post-epidural Cold Pain Threshold QST Results | -7.35 Degrees Celsius | Standard Deviation 9.11 |
p-value: 0.04Kruskal-Wallis
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.
Time frame: 4 weeks after the epidural injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| >30% Pain Relief | Post-epidural Continued Pain Modulation (CPM) | -0.53 units on a scale | Standard Deviation 2.01 |
| <30% Pain Relief | Post-epidural Continued Pain Modulation (CPM) | -4.08 units on a scale | Standard Deviation 4.67 |
p-value: 0.04Kruskal-Wallis
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.
Time frame: Baseline measurement before the epidural injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| >30% Pain Relief | Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results | 2.68 Degrees Celsius | Standard Deviation 2.92 |
| <30% Pain Relief | Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results | 5.67 Degrees Celsius | Standard Deviation 3.22 |
p-value: 0.04Kruskal-Wallis