Pain Medicine

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Pain Management Research: Current Studies

PROMISE (Prospective, randomized study of multicolumn implantable lead stimulation for predominant low back pain)
Randomized study of patients with failed back surgery syndrome, both chronic lower-back pain and leg pain where back pain is at least a five on a numeric pain rating scale. Subjects must have had surgery more than six months prior to enrollment visit and cannot have a history of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, ankylosing spondylitis, calcific arachnoiditis, or severe thoracic stenosis. Subjects will be randomized to either an Optimal Medical Management arm (OMM) where non-surgical and alternative pain treatments are used or a Spinal Cord Stimulation (SCS) + OMM arm where OMM is used along with a surgically implanted neurostimulation device.

Enrollment Target (WCMC and study wide): 25 / 400
Enrollment status (WCMC and study wide): 0

IRB Protocol # 1209013020

Predicting oxycodone dose from oral fluid drug levels for chronic pain medicine patients
Study analyzing the opioid drug levels in three different samples from chronic pain patients who are regularly taking opioid medications. Patients must be between 18-72 years of age, suffer from chronic pain, be taking prescribed opioid medication and must not have any chronic liver or kidney diseases or impairments. Subjects provide a blood, urine, and saliva sample which is analyzed at a laboratory. Enrollment is complete once the subject gives the samples.

Enrollment Target (WCMC and study wide): 55
Enrollment status (WCMC and study wide): 6

IRB Protocol # 1212013319

A prospective, non-randomized, open-label, multicenter study to estimate the long-term safety of the Prometra Programmable Pump System
This is a Post-Approval Study to collect long-term data on the use of the Prometra System in the post-approval setting and to provide continued reasonable assurance of the safety of the device. Subjects older than 22 years-old are divided into two groups: Group A: subjects who require the implantation of an intrathecal drug pump and Group B: subjects who already participated in one of two previous Prometra Pump clinical trials and already have an implanted Prometra Pump System. Subjects will be followed for a total of five years to collect long term data on the safety of the pump system.

Enrollment Target (WCMC and study wide): 40 / 400
Enrollment status (WCMC and study wide): 0

IRB Protocol # 1308014264 (PENDING APPROVAL)

RELIEF A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
A prospective, multi-center, global registry to compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice. Subjects are followed up with and issued questionnaires about pain relief levels and daily activities every 6 months for a total of 36 months starting from the date of the neurostimulation trial. Subjects must be over 18 years-old and be scheduled to receive a commercially approved Boston Scientific neurostimulation system.

Enrollment Target (WCMC and study wide): 50 / 4800
Enrollment status (WCMC and study wide): 0

IRB Protocol # 1309014281 (PENDING APPROVAL)

Chronic Pain Registry
The purpose of this project is to establish a retrospective chronic pain patient data registry for patients with chronic pain, and to use the patient data registry along with Practice Based Evidence (PBE) and Clinical Practice Improvement (CPI) methodology to identify specific pain management interventions that are most effective for specific patient types with chronic pain. Data is retrospectively reviewed from surveys that chronic pain patients at the WCMC Pain Management Center, the Pain and Palliative Care Clinic at MSKCC and the Hospital for Special Surgery fill out as part of their routine clinical visits.

Enrollment Target (WCMC and study wide): 10,000
Enrollment status (WCMC and study wide): ?

IRB Protocol # 0904010349

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