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

Mass General Brigham

Status: Completed

Conditions: Radiculopathy; Lower Extremity Radicular Pain

Treatments: Procedure: Epidural Steroid Injection (ESI); Device: Quantitative Sensory Testing (QST)

Study type: Interventional

Funder types: Other

Identifiers

NCT02130258

2011P002234

Details and patient eligibility

About

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).

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

>30% Pain Relief

Other group

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.

Treatment:

Device: Quantitative Sensory Testing (QST)

Procedure: Epidural Steroid Injection (ESI)

<30% Pain Relief

Other group

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.

Treatment:

Device: Quantitative Sensory Testing (QST)

Procedure: Epidural Steroid Injection (ESI)