International Reflex Sympathetic Dystrophy Foundation

"Dedicated To Helping RSD Patients Worldwide"

Eric M. Phillips

P.O. Box 474

North Dighton, Massachusetts 02764-0474 USA

Phone: 774-501-2808  Fax: 774-501-2808

E-mail: utopia33@prodigy.net

 

Office Hours

Monday through Friday

9:00 A.M. to 5:00 P.M. EST

(Please note our new mailing address and phone numbers)

 

Please view the following new topics: The Management of CRPS, Movement Disorders, Principles of Addiction, New Topics, Spread of CRPS, The Infusion Pump: Clinical Observation, Spine and the Autonomic Nervous System, Bone Scan and CRPS, CRPS and SCS, Dr.Ellen G. Wattay's Updated Manual for the Diagnosis and Treatment of RSD/CRPS I, Clinical Contribution To CRPS I, RSD Poems, RSD Stories, Clinical Trials: Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type I, CRPS and Sympathectomy, The National Disease Research Interchange (NDRI), Next Step O&P, Stages of CRPS/RSD, and Thermography Abstract.

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Clinical Trials

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The following new clinical trials are being conducted by the National Institute of Health (NIH) in Bethesda, MD.

Please click on the links below to view more information regarding these studies.

Rank Status Study
1 Not yet recruiting Pain Exposure Physical Therapy (PEPT) Versus CBO in Patients With Complex Regional Pain Syndrome Type I (CRPS-1)
Condition: Complex Regional Pain Syndrome, Type I
Interventions: Procedure: PEPT;   Procedure: CBO standard
2 Not yet recruiting Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)
Condition: Complex Regional Pain Syndrome Type I
Interventions: Behavioral: Graded exposure in vivo;   Behavioral: Physiotherapy
3 Recruiting Neurotropin to Treat Chronic Neuropathic Pain
Conditions: Causalgia;   Reflex Sympathetic Dystrophy
Intervention: Drug: Neurotropin
4 Recruiting Evaluation and Diagnosis of People With Pain and Fatigue Syndromes
Conditions: Fatigue;   Fibromyalgia;   Pain;   Complex Regional Pain Syndrome;   Reflex Sympathetic Dystrophy
Intervention:  
5 Completed Prophylactic Administration of Vitamin C in Wrist Fractures
Conditions: RSD (Reflex Sympathetic Dystrophy);   Algodystrophy;   CRPS Type I
Intervention: Drug: ascorbic acid (vitamin C) versus placebo
6 Completed Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1
Condition: Complex Regional Pain Syndrome, Type I
Interventions: Drug: lenalidomide (CC-5013);   Drug: Placebo
7 Completed Positron Emission Tomography to Measure Pain and Pain Control
Conditions: Healthy;   Hyperalgesia;   Pain;   Peripheral Nervous System Disease
Interventions: Drug: Oxygen-15 Water;   Drug: Capsaicin
8 Completed A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)
Condition: Complex Regional Pain Syndrome (RSD)
Intervention: Drug: Lenalidomide
9 Recruiting Safety and Efficacy Study of Ethosuximide for the Treatment of Complex Regional Pain Syndrome (CRPS).
Condition: Complex Regional Pain Syndrome
Interventions: Drug: Placebo;   Drug: Ethosuximide
10 Completed A Pilot Clinical Trial of Sympathetic Blockade With Botulinum Toxin Type A to Treat Complex Regional Pain Syndrome (CRPS): a Randomized, Double-Blind, Controlled, Crossover Trial
Condition: Pain
Intervention: Procedure: Lumbar sympathetic block with Botulinum Toxin type A
11 Completed Study of Proteins Associated With Complex Regional Pain Syndrome
Conditions: Complex Regional Pain Syndromes;   Healthy
Intervention:  
12 Completed Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women
Condition: Forearm Fracture
Intervention: Drug: Salmon calcitonin
13 Recruiting Pregabalin Versus Placebo as an Add on for Complex Regional Pain Syndrome (CPRS) of the Upper Limb Managed by Stellate Ganglion Block (The PREGA Study)
Condition: Complex Regional Pain Syndromes
Interventions: Drug: Pregabalin;   Other: Placebo

 

 

 

The following new clinical trial is for patients who suffer from CRPS Type I.

Medical Research

Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type I.

Sponsored by: Celgene Corporation

Purpose

This is a multi-center, double blind, placebo-controlled study in adult subjects with Complex Regional Pain Syndrome (CRPS) Type I .

One hundred eighty (180) subjects diagnosed with unilateral CRPS Type I will be enrolled and randomized to receive orally either 10mg per day of Lenalidomide or placebo (90 subjects per treatment). For each subject, the subject consists of three phases. Pre-randomization Phase (2 weeks), Treatment Phase (12 weeks) and Extension Phase (up to 52 weeks).

 

Condition

Treatment or Intervention

Phase

Complex Regional Pain Syndrome (RSD) Type I

Drug: Lenalidomide

Phase II

 

Study Type

Interventional

Study Design

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Group Assignment, Safety/Efficacy Study.

Further Study Details

Expected Total Enrollment

180

Study start

January, 2005

Study completion

January, 2007

Eligibility

Ages Eligible for Study

18 years and above

Genders Eligible for Study

Both

Criteria

Inclusion Criteria

bullet Age 18 years at the time of signing the informed consent form

 

bulletUnderstand and voluntarily sign an informed consent form

 

bullet A diagnosis of CRPS Type I as defined by modified International Association for the Study of Pain criteria for at least one-year duration. Unilateral involvement of a distal limb (hand or foot) with or without proximal spread must be present. In the presence of upper and lower limb involvement, the most severely affected limb will be designated the CRPS-affected limb.

 

bulletScreening (Visit 1): CRPS pain intensity score in the CRPS-affected limb
must be at least 4 on an 11-point (0-10) PI-NRS

 

bulletRandomization (Visit 2): Average PI-NRS score for randomization
purposes (Visit 2) will be based on AM and PM assessments made during the 7 days prior to randomization:
bulletAt least eight PI-NRS scores during this 7-day period are  required and
bulletAverage PI-NRS score in the CRPS-affected limb during this
period must be at least 4 on an 11-point (0-10) PI-NRS.

 

bulletMeasurable (by electrophysiology methods) sural, median sensory,
median motor and peroneal motor nerves at the screening nerve
conduction study.

 

bulletOpioid analgesics, non-opioid analgesics, non-steroidal anti-inflammatory drugs, anticonvulsants, antidepressant drugs and other non-drug therapies may be continued provided that the subject is on stable doses/regimens for at least four weeks prior to the start of the Treatment Phase (Visit 2).

 

bulletAble to adhere to the study visit schedule and other protocol requirements.

 

bulletWomen of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. The use of steroid-based contraceptives (oral, injectable or implanted) is not permitted in this study. WCBP must agree to have pregnancy tests every 4 weeks while on study drug.
bulletA woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).

 

Exclusion Criteria

The presence of any of the following will exclude a subject from study enrollment:

bulletHistory of deep vein thrombosis (DVT) or stroke in the past 5 years.

 

bulletDocumented peripheral neuropathies to include diabetic neuropathy
and other metabolic or toxic neuropathies.

 

bulletCurrent signs or symptoms of severe, progressive or uncontrolled renal,
hepatic, hematological, endocrine, pulmonary, cardiac, neurological or
cerebral disease.

 

bulletAny other serious medical condition, laboratory abnormality, or
psychiatric illness that would prevent the subject from signing the
informed consent form.

 

bulletWhite blood cell count (WBC) < 3.5 x 109 / L at Visit 1.

 

bulletBilirubin, alanine transaminase (ALT), aspartate transaminase (AST) or
alkaline phosphatase levels more than two times the upper limit of the
normal range at Visit 1.

 

bulletAbnormal thyroid function test values at Visit 1.

 

bulletAny condition, including the presence of laboratory abnormalities,
which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

 

bulletUse of concomitant medication(s), including steroid-based
contraceptives (oral, injectable or implanted) and hormone replacement
therapies which could increase the risk for developing DVT.

 

bulletConcurrent use of thalidomide.

 

bulletPrior development of an allergic reaction/hypersensitivity while taking
thalidomide.

 

bulletPrior development of a moderate or severe rash or any desquamation
while taking thalidomide.

 

bulletPrior treatment with Lenalidomide.

 

bulletIf you feel you meet the above criteria for inclusion in this study and are interested in participating or would like more information please contact Space Coast Neurology in Palm Bay, Florida at:  (321) 984-7997. Dr. Hashmi, the study investigator or Pauline Cobble the site coordinator will be more than happy to assist you. Please visit Space Coast Neurology website at: www.rsdconsultants.com

 

 

The following two clinical trials are being conducted at the National Institute of Health (NIH) in Bethesda, MD, for patients who suffer from RSD/CRPS.

Study of Proteins Associated with

Complex Regional Pain Syndrome

This study is currently recruiting patients

Sponsored by:

National Institute of Dental and Craniofacial Research (NIDCR)

 

For more information please contact:

National Institute of Dental And Craniofacial Research (NIDCR)

9000 Rockville Pike,

Bethesda,  Maryland,  20892  USA

Patient Recruitment and Public Liaison Office  800-411-1222    TTY  866-411-1010  prpl@mail.cc.nih.gov 

Please click on the link below for information regarding this clinical trial

http://clinicaltrials.gov/ct/show/NCT00033969?order=1

 

 

Neurotropin to Treat Acute Dental

and Chronic Neural Pain

This study is currently recruiting patients

Sponsored by:

National Institute of Dental and Craniofacial Research (NIDCR)

 

For more information please contact:

National Institute of Dental And Craniofacial Research (NIDCR)

9000 Rockville Pike,

Bethesda,  Maryland,  20892 USA

Patient Recruitment and Public Liaison Office  800-411-1222    TTY  866-411-1010  prpl@mail.cc.nih.gov 

Please click on the link below for information regarding this clinical trial

http://clinicaltrials.gov/ct/show/NCT00006289?order=2

*For more information regarding current and future clinical trials please visit: http://clinicaltrials.gov/

The material on the IRSDF Homepage and all its associated, linked or reference pages is for informational and education purposes. It is not meant to take the place of your physician. Before starting, changing, or stopping any treatments or medicines consult your physician.
Eric M. Phillips, and Associates will not be held liable for any damage or loss as a result of information provided on this page or associated documentation. Again, this WEBSITE is simply published as an information source and should not be used to treat or make judgments on RSD. All material owned by others, that is distributed or published on this website, disk media, facsimile or copied through electronic or photographic means has been done so with the permission of the owner or author. Any and all material published in error, will be immediately removed or corrected upon notification of such. The IRSDF organization title known as the "International Reflex Sympathetic Dystrophy Foundation" and all associated material on this website may not be copied, reproduced or quoted without expressed written permission from the owner;  Copyright  1996-
2014  Eric M. Phillips- Last Update 6/19/2009

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