Pain is one of the most common reasons for visiting a physician. Although
there are a wide range of treatments now available, new approaches are
being investigated. At Beth Israel Medical Center's Department of Pain
Medicine and Palliative Care, studies are currently recruiting patients
with some types of chronic pain, neuropathic pain, pain due to cancer,
and low back pain.
Neuropathic pain includes many conditions caused by injury to nerves. The
discomfort experienced by patients with this type of pain can be severe, long-lasting,
and not easily treated by current analgesics.
Clinical trials are also currently underway to study breakthrough pain,
cancer pain, chronic pain, methadone, and novel pain treatments.
For more information write or call
Ella Dvorkin, CCRP
Senior Research Manager
Department of Pain Medicine and Palliative Care
Beth Israel Medical Center
16th Street and First Avenue
NY, NY 10003
Phone: (212) 844-8536
Email: stoppain@chpnet.org
Effect of Methadone on the QTc Interval
IRB #095-07 Effect of Oral Methadone on
the QTc Interval in Patients at Risk for QTc Prolongation
Principal Investigator: Ricardo Cruciani,
MD, PhD
Contact: Arun Sundaram, 212-844-8533
Status: Open for Enrollment
Design: The primary objective of this
study is to explore the association between methadone treatment in older
population and cardiac toxicity, and determine the sensitivity of a
single ECG compared to 24-hour monitoring in capturing cardiac events
indicative of this toxicity.
Given the expanding role of methadone in the treatment of pain, more research
is needed to determine its effect on the electrical properties of the
heart in the clinical setting. The present study has been designed as
a continued effort to clarify an association between methadone and QTc
prolongation.
This study has been funded by the U.S Cancer Pain Relief Committee.
Effect of Milnacipran or Placebo
on Ventricular Lactate and FM-Induced “Brain Fog”
IRB #212-09 Effect of Milnacipran or Placebo
on Ventricular Lactate and FM-Induced “Brain Fog”
Principal Investigator: Benjamin H. Natelson, MD
Contact: Diana Vu, 212-844-6747
Status: Open for Enrollment
Design: The primary objective of this
study is to determine if patients with Fibromyalgia have elevated levels
of ventricular lactate, which has been identified as a possible biomarker
in some patients with Chronic Fatigue Syndrome and to determine if Minalcipran,
a drug that alters brain chemistry to reduce pain, reduces ventricular
lactate levels in these patients. The secondary objective of this study
is to determine whether Milnacipran improves attention and concentration
difficulty, which is a major complaint among FM patients.
Eligible study participants include individuals who experience pain
all over their body with no apparent cause or patients who have received
the diagnosis of Fibromyalgia.
This study is being funded by Forest Labs, the manufacturer of Milnacipran.
Pain and Smoking After Successful Treatment
for Head and Neck Cancer
IRB #089-07 Establishing the Connection
between Pain and Smoking After Successful Treatment for Head and Neck
Cancer: A “Proof-of-Principle” Observational Pilot Study
Principal Investigator: Lara Dhingra,
PhD
Contact: Lara Dhingra, PhD, 212-844-1429
Status: Open for Enrollment
Design: This pilot study employs an innovative
data collection methodology, ecological momentary assessment (EMA),
in which a handheld computer is used to repeatedly measure pain and
smoking behavior during the day in a group of head and neck cancer survivors
who have pain and are current smokers.
This study will yield a novel contribution to the current literature on
smoking in head and neck cancer survivors and will inform the development
of new interventions for smoking cessation in this population.
Eligible participants include cancer survivors who have no evidence
of disease following successful treatment for head and neck cancer;
currently smoke 5 or more cigarettes per day, and have frequent or persistent
pain. Read
more (.pdf) ...
This study has been funded by the Beth Israel Head and Neck and Thyroid
Cancer Institute.
Pain and Function
in Hip Fracture
IRB #147-08 Improving Pain and Function
in Hip Fracture
Principal Investigator: Knox Todd, MD
Contact: Taja Ferguson, email: taja.ferguson@mssm.edu
Status: Open for Enrollment
Design: This project examines the efficacy
of two regional anesthesia techniques, femoral nerve blocks (FNB) and
fascia iliaca blocks (FIB), on the treatment of acute hip fracture pain.
Patients age 60 years and over presenting the emergency department with
hip fracture will be randomized to receive the intervention or usual
care. The intervention includes FNB in the ED followed by insertion
of a continuous FIB catheter within 24 hours plus non-opioid/opioid
analgesia as needed. Usual care patients will receive conventional therapy
with regularly scheduled and as needed intravenous or oral opioids.
We will examine the impact of the intervention on patients’ pain
intensity; systemic opioid requirements; post-operative function; incidence
of delirium, side effects; hospital length of stay and participation
in physical therapy.
This study has been funded by the National Institute of Aging/NIH and is conducted in collaboration with Mount Sinai School of Medicine.
tDCS Research Study
IRB #038-08 Pilot Study on Safety and Efficacy
of the Non-Invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic
Pain in Cancer Patients
Principal Investigator: Ricardo Cruciani, MD,
PhD
Contact: Helena Knotkova, PhD, 212-844-8541
Status: Open for Enrollment
Participants: Subjects with a history of head and neck cancer and neuropathic pain
Design: The purpose of this study is to
determine if transcranial direct current stimulation (tDCS), the device
that regulates brain activity, can improve pain in people with a history
of head and neck cancer who have developed neuropathic pain as a result
of a surgical procedure, chemotherapy or radiation therapy.
This study has 2 parts; PHASE 1 and PHASE 2. If you qualify, your study
participation may last up to 7 weeks with up to 13 clinic visits expected.
These clinic visits will last about one hour. During the rest of the
study, you can remain at home.
In the double-blind, sham controlled Phase 1; participants will be randomized
2:1 into two arms to receive either the real tDCS treatment (group A,
16 participants) or sham (group B, 8 participants) in 5 sessions on
5 consecutive days. Patients whose pain will not improve at least by
3 of 10 points on the numerical pain rating scale at the end of the
double-blind Phase 1 will continue to the open-label Phase 2 of the
study and will receive the real tDCS treatment, i.e. 20 min of tDCS
at 2 mA, in 5 sessions on 5 consecutive days. About
tDCS (.pdf)...
Institute for Noninvasive Brain Stimulation of New York (INBSNY), 212-844-8539
For more information on these studies, please write or call:
Ella Dvorkin, CCRP
Senior Research Manager
Department of Pain Medicine and Palliative Care
Beth Israel Medical Center
16th Street and First Avenue
New York, NY 10003
Telephone: (212) 844-8536
Email: stoppain@chpnet.org
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