RadiculopathyNCT02130258
Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome
A study testing Quantitative Sensory Testing (QST) and Epidural Steroid Injection (ESI) in people with Radiculopathy and Lower Extremity Radicular Pain, run by Massachusetts General Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiculopathy, Lower Extremity Radicular Pain
- What is being tested?
- Quantitative Sensory Testing (QST) and Epidural Steroid Injection (ESI)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of lower extremity radicular pain regardless of specific or suspected etiologies
- scheduling an epidural steroid injection (ESI)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Center for Translational Pain Research
Boston, Massachusetts, 02114
About this study
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).
Read the 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.
- Conditions
- Radiculopathy, Lower Extremity Radicular Pain
- Being tested
- Quantitative Sensory Testing (QST), Epidural Steroid Injection (ESI)
- Keywords
- Radicular, Pain, Epidural Steroid Injection
- Medical subject headings
- Radiculopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory Testing (QST)Device
Subjects will undergo hot and cold temperature testing using the QST device at two points: 1) Before ESI and 2) after ESI.
Epidural Steroid Injection (ESI)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| >30% Pain Relief | Other | 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. Receives: Device: Quantitative Sensory Testing (QST); Procedure: Epidural Steroid Injection (ESI) |
| <30% Pain Relief | Other | 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. Receives: Device: Quantitative Sensory Testing (QST); Procedure: Epidural Steroid Injection (ESI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline measurement before the epidural injection
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.
Measured: 4 weeks after the epidural injection
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.
Measured: 4 weeks after the epidural injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startMay 2012
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Zhang, MD, Massachusetts General Hospital
- Investigators
- Yi Zhang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130258
- Sponsor's protocol ID
- 2011P002234
- Status last verified
- Feb 2018
- First submitted
- 24 Apr 2014
- Last updated
- 8 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome
- ClinicalTrials.gov ID
- NCT02130258
- Acronym / sponsor ID
- 2011P002234
- Conditions
- Radiculopathy, Lower Extremity Radicular Pain
- Keywords
- Radicular, Pain, Epidural Steroid Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 May 2014 (estimated)
- Results
- Posted 8 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| >30% Pain Relief | Other | Device: Quantitative Sensory Testing (QST), Procedure: Epidural Steroid Injection (ESI)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 | Other | Device: Quantitative Sensory Testing (QST), Procedure: Epidural Steroid Injection (ESI)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of lower extremity radicular pain regardless of specific or suspected etiologies
- scheduling an epidural steroid injection (ESI)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | <30% Pain Relief, >30% Pain Relief |
| 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. | Procedure or surgery | <30% Pain Relief, >30% Pain Relief |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MGH Center for Translational Pain ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Zhang, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative Sensory Testing (QST) and Epidural Steroid Injection (ESI) in people with Radiculopathy and Lower Extremity Radicular Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results (time frame: Baseline measurement before the epidural injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.