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
Breakthrough Pain in Patients with Cancer
IRB #214-06 An Open-Label Study Investigating
Long-Term Safety and Tolerability of Nasalfent (Fentanyl Citrate Nasal
Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects
Taking Regular Opioid Therapy
Principal Investigator: Russell K. Portenoy,
MD
Contact: Ella Dvorkin, CCRP, 212-844-8536
Status: Open for Enrollment
Design: This is an open-label study conducted
at approximately 100 centers in the United States, Canada and Europe.
The objectives of the study are to investigate the long-term safety,
tolerability, and acceptability of Nasalfent in the treatment of breakthrough
cancer pain.
The study drug, NASALFANET, is a nasal formulation of fentanyl. The
nasal route has the potential to deliver the drug rapidly, and is safe
and convenient for most subjects. Fentanyl is a well-established and
characterized drug, with many years of clinical use. Its side-effect
profile is well documented, and is qualitatively similar to that of
other opioid analgesics.
The study will enroll subjects ages 18 and older with a clinical diagnosis
of cancer related pain. Subjects who are taking regular, 24-hour medication
(60 mg oral morphine or equivalent opioid) for his or her underlying
persistent cancer pain and who typically have 1 to 4 episodes of breakthrough
cancer pain per day are eligible for participation.
Study participation will last for approximately 16 to 18 weeks. Following
this Main Study, subjects will have the opportunity to enter a long-term
Extension Phase where they will be allowed to use Nasalfent for as long
as necessary, up until the time that Nasalfent becomes commercially
available in this country. Read
more (.pdf)...
This study has been funded by Archimedes Development Limited.
Chronic Pain
IRB #150-07 Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug Abuse
Principal Investigator: Russell K. Portenoy,
MD
Contact: Arun Sundaram, 212-844-8533
Status: Open for Enrollment
Design: The primary objective of this
study is to create a set of guidelines for the use of sublingual buprenorphine
in the treatment of chronic pain in populations with substance use disorders.
These guidelines will be developed by an expert panel comprising leaders
in pain medicine, addiction medicine and buprenorphine pharmacology.
Subjects will include 40 patients with chronic pain and substance abuse
histories or current aberrant drug-related behavior. All patients will
be recruited at Beth Israel Medical Center.
This study is being conducted by the National Development and Research
Institutes (NDRI) and the Beth Israel Medical Center (BIMC) and is funded
by the National Institute on Drug Abuse.
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.
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: Alyce Caulfield, MPH, 212-420-2604
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 Patients with Head and Neck Cancer
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
tDCS Research Study
IRB #096-07 Relations Between Excitability
of the Somatosensory Cortex and Pain Relief Induced by the Transcranial
Stimulation (tDCS) in Patients with Complex Regional Pain Syndrome
Principal Investigator: Helena Knotkova, PhD
Contact: Helena Knotkova, PhD, 212-844-8541
Status: Open for Enrollment
Participants: Subjects with CRPS-related pain localized in an upper limb, and 10 tDCS naïve healthy volunteers
Design: This is a pilot, prospective,
controlled, open-label trial, with the goal to determine relations between
excitability of the somatosensory cortex and pain-relief induced by
the tDCS in patients with CRPS-related pain. The study will enroll 10
tDCS naïve patients with CRPS-related pain localized in an upper
limb, and 10 tDCS naïve healthy volunteers.
All participants (patients and healthy volunteers) will undergo a
screening procedure, including physical examination and clinical laboratory
tests. One week later (allowing the study personnel to obtain and evaluate
lab results), individuals who qualify for the study and meet Inclusion/Exclusion
criteria will undergo SSEP recordings and will receive the first tDCS
stimulation. The second and the third tDCS stimulation will be done
on two following consecutive days. SSEPs will be recorded again at the
end of the third tDCS session, and participants will undergo physical
examination and clinical laboratory tests.
The study will last up to 2 weeks and will consist
of four study visits (the screening visit and three
tDCS sessions with SSEPs recordings before the first- and after the
last tDCS stimulation). About
tDCS (.pdf)...
Institute for Noninvasive Brain Stimulation of New York (INBSNY),
212-844-8539
tDCS Research Study
IRB #098-06 Pilot Study on Safety and Efficacy
of the Non-invasive Transcranial Stimulation (t-DCS) to Relieve Neuropathic
Pain in Patients with Complex Regional Pain Syndrome
Principal Investigator: Ricardo Cruciani, MD,
PhD
Contact: Helena Knotkova, PhD, 212-844-8541
Status: Open for Enrollment
Participants: Patients with CRPS/RSD with
affected an upper or lower limb and a unilaterally localized CRPS-related
pain
Design: This pilot study is proposed as
a two-arm randomized sham-controlled trial to determine the effect tDCS
stimulation at current intensity of 2 mA performed on five consecutive
days, on pain, somatosensory abnormalities and motor function in patients
with CRPS-related neuropathic pain.
Patients will be randomized into two arms of the study to receive either
the real tDCS treatment (group A) or sham (group B). When randomized,
participants will undergo initial (baseline) evaluation of pain, somatosensory
abnormalities, and motor function of the affected vs. unaffected limb.
Then, patients will undergo 5 sessions of 20 min of 2 mA stimulation
(group A) or sham (group B) on 5 consecutive days. Two weeks after the
last tDCS treatment/sham, patients will come for the follow-up visit.
Patients who will not experience pain relief in the sham-controlled
part of the study will continue in the open-label part of the study
and will receive the real tDCS treatment in 5 sessions of 20 min of
2 mA stimulation on 5 consecutive days, Mon-Fri. To participate in the
study, patients do not have to change their medication regimen.
The duration of the study is up to 6 weeks. 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
|