Friday, September 18, 2009

CRPS/RSD Clinical Trials, September Update

Get details (such as where studies are conducted, and by whom) by clicking on the initial link.

Please pay close attention to study requirements -- sometimes involvement of certain limbs is specified, sometimes a distinction between CRPS Type 1 or 2, sometimes length of illness. Some studies require procedures, some offer treatments (blindly), some require that you not have had any prior treatment.

I have no information regarding remuneration.

I eliminated three studies from the current list called up by the search term "CRPS," as they appeared only loosely related, or not at all.

One short editorial comment! I received an email after my last Clinical Trials posting, the author of which was upset by some mention of psychology/psychiatry in a trial. There is a real fear among people with CRPS, a fear of having pain minimized or dismissed by associating it with depression or anxiety. That fear needs to be addressed, and the mechanics of pain better understood. I encourage anyone with CRPS to find emotional support -- it is IMPOSSIBLE to have this disease without falling prey to the psychological consequences of persistent and severe pain, disability, and the social isolation that often occurs.

** Cerebrospinal Fluid Repository
Conditions: Amyotrophic Lateral Sclerosis; Cerebrospinal Fluid; Neurodegenerative Disease; Motor Neuron Disease
Intervention: "The purpose of a CSF repository is to collect samples of spinal fluid from controls and patients with neurologic disorders including but not exclusively ALS, Dementia, CRPS, neuropathies, and other neuromuscular diseases. This CSF repository will allow the use of CSF in biochemical studies of various neurologic diseases. It would also provide a supply of the necessary normal and disease control patients. CSF would be obtained from patients who are undergoing spinal taps for other reasons including diagnosis, treatment, or participation in clinical trials.

** Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome
Condition: Complex Regional Pain Syndrome
Interventions/Device: Spinal Cord Stimulator;
Other: CRPS patients under treatment other than spinal cord stimulator
"To demonstrate that spinal cord stimulator has an effect on sympathetic function. Therefore, if the spinal cord stimulator has an effect on sympathetic function, the responses from CRPS patients to different stimuli will differ significantly pre and post SCS implant. If CRPS patients exhibit autonomic, CRPS patients could be stratified according to their sympathetic function pre-implant. It is expected that patients with a moderate/mild form of autonomic dysfunction will have better outcomes with the SCS."

** Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)
Conditions: Complex Regional Pain Syndromes; CRPS
Intervention/Drug: Delta9-Tetrahydrocannabinol
Study is at University of Munich. Complete title: Low Dose Administration of Delta9-Tetrahydrocannabinol for the Prevention of Hyperalgesia and Chronic Pain in Patients With Acute Complex Regional Pain Syndrome (CRPS) of the Upper Limb

** 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
Study is at McGill (Montréal). "Pain remains the most debilitating symptom for adult patients suffering from complex regional pain syndrome (CRPS). Most CRPS patients gain little to no relief from current painkillers. The purpose of this study is to evaluate the efficacy and safety of ethosuximide in search of much-needed adjunctive therapy to relieve the pain and suffering associated with CRPS."

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
Study by Maastricht University Medical Center. "Research on the treatment of CRPS-I, as described in the Dutch evidence based treatment guidelines (Richtlijn Complex Regional Pain Syndrome type I, 2006), mainly showed improvement at the level of pain and coping with pain. Only little improvement in functional restoration was found. Research in other pain populations such al neck- and back-pain patients has shown that pain related fear contributes to the development of functional disability. GEXP in vivo which aims on systematically reducing fear of movement, shows promising results in CRPS-I patients (de Jong et al., 2005)."

** Double Blind Placebo Controlled Study of Outpatient Intravenous Ketamine for the Treatment of CRPS
Condition: Complex Regional Pain Syndrome
Interventions/Drug: Ketamine; Other: IV NSS; Other: Normal Saline
Drexel University (Schwartzman et al). "Complex Regional Pain Syndrome is a debilitating and extremely difficult to treat condition. There is a large body of evidence demonstrating the therapeutic value of N-methyl-D-aspartate (NMDA)-receptor antagonists in CRPS. The NMDA antagonist ketamine has been shown to be effective in the treatment of CRPS, resulting in complete remission of the disease in some patients. The purpose of this study is to evaluate intravenous outpatient infusion of sub-anesthetic doses of ketamine for the treatment of CRPS. A thorough evaluation of this procedure, providing information into the degree of relief and which of the constellation of RSD symptoms are best alleviated by this procedure would result in the optimization of this therapy for the treatment of CRPS."

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
Radboud University, The Netherlands. "The current Dutch CBO guideline treatment of Complex Regional Pain Syndrome Type I (CRPS-1) is very disappointing with chronification, disability and subsequent high medical costs and personal suffering. A possible better treatment is intensive function-oriented physical therapy or Pain Exposure in Physical Therapy (PEPT). However, there are no adequate studies performed that demonstrate the efficacy of PEPT and therefore PEPT is lacking in the Dutch CBO CRPS-1 guidelines. Despite a lacking scientific argumentation, the PEPT approach or Macedonian therapy, is now being adopted on a large scale among physical therapists in The Netherlands. There are two level C retrospective cohort studies demonstrating a promising and clinical relevant beneficial effect on pain and function after PEPT. In response to the growing demand for scientific argumentation among doctors and physical therapists with respect to the efficacy of PEPT, we conducted a pilot study at the UMC St Radboud Nijmegen. The results of this pilot study were very promising and therefore, we decided to design a large RCT to investigate the treatment effects and costs in CRPS patients treated with PEPT compared to CRPS patients treated with usual therapy according to the Dutch CBO guidelines."

** Association Between Focal Dystonia and Complex Regional Pain Syndrome
Conditions: CRPS; Focal Dystonia; Peripheral Nervous System Disease
National Institute of Neurological Disorders and Stroke (NINDS). "This study will investigate differences among people with focal dystonia (FD), complex regional pain syndrome (CRPS) and people who have both conditions to learn more about the cause of both disorders. Participants undergo the following procedures in five visits..." Procedures range from EEG, MRI,TMS, EMG, to skin biopsy.

Not yet recruiting
** The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy
Conditions: Diabetic Neuropathies; Complex Regional Pain Syndrome Type II
Intervention/Device: TDCS/sham procedure on five consecutive days
Pain and palliative care unit, Ben Gurion University of the Negev
Beer-Sheva, Israel. "This is a controlled trial designed to determine short- and long-term effects of repeated tDCS on the P300 component of event-related evoked potentials in patients with chronic neuropathic pain due to Complex regional Pain Syndrome (CRPS) or diabetic neuropathy as compared with healthy subjects."

Not yet recruiting
** Intravenous Immunoglobulins in Complex-regional Pain Syndrome
Condition: Complex Regional Pain Syndrome Type 1
Intervention/Biological: intravenous immunoglobulins
Hospital of the Justus-Liebig-University, Giessen, Hessen, Germany. "More than one third of the CRPS will continue to chronic disease including loss of function in one limb. Some reports implicate an autoimmune pathogenesis of CRPS. Especially the finding of autoantibodies against peripheral neurons and successful treatment in single cases provide evidence for a possible successful treatment of CRPS with intravenous immunoglobulins (IvIg). Therefore IvIg may be an important anti-inflammatory treatment to prevent severe chronification of CRPS. Since IvIg is mainly effective in B-cell-mediated autoimmune diseases, autoantibodies against autonomic neurons and the concentration of B-cell activating factors BAFF and APRIL will be measured in the course of the study."

** A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1
Condition: Complex Regional Pain Syndrome, Type 1
Intervention/Drug: Lenalidamide
Mayo Clinic/Elgene Chemical.

** 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
Hamilton Health Sciences/Pfizer/McMaster University.

** The Efficacy of Motor Cortex Stimulation for Pain Control
Conditions: Neuropathic Pain; Phantom Limb Pain; Stump Pain; Brachial Plexus Avulsion; Deafferentation Pain; Facial Pain; Complex Regional Pain Syndrome
Intervention/Device: motor cortex stimulation
Capital District Health Authority, Canada. "This is a prospective, blinded randomized crossover study comparing two stimulation paradigms in three different groups of patients receiving motor cortex stimulation. The aim of this study is to examine the effectiveness of this modality in a controlled blinded manner, which has not been done in previous studies. There are two primary purposes of this study. The first is to compare two different stimulation paradigms: "high" level stimulation (i.e. stimulator activated 'on' for 10 minutes, 'off' for 2 hours; presumed therapeutic dose); versus "low" stimulation ('on' for 1 minute, 'off' for 6 hours; presumed subtherapeutic dose), in a prospective blinded crossover study design.
The second purpose of this study, is to examine the outcome of MCS in three different pain groups. These are: Unilateral upper extremity neuropathic pain such as brachial plexus avulsion, stump pain or phantom limb pain; Neuropathic deafferentation facial pain; Upper extremity complex regional pain syndrome (CRPS)"

** Neurotropin to Treat Chronic Neuropathic Pain
Conditions: Causalgia; Reflex Sympathetic Dystrophy
Intervention/Drug: Neurotropin
National Institute of Nursing Research (NINR). "Patients with Reflex Sympathetic Dystrophy (RSD), re-named Complex Regional Pain Syndrome, type I (CRPS-I), have chronic, post-traumatic pain that spreads beyond the distribution of any single peripheral nerve without evidence of major peripheral nerve damage. A similar disorder, Causalgia, re-named CRPS-II, presents with clear evidence of nerve injury. No successful drug treatment exists for these disorders. Neurotropin is a non-protein extract of cutaneous tissue from rabbits inoculated with vaccinia virus. Neurotropin has been used extensively in Japan to treat RSD and other painful conditions; however, the drug has not undergone clinical therapeutic testing in the United States. This protocol is to carry out double-blind, placebo-controlled, crossover studies about clinical efficacy of Neurotropin for acute pain in dental outpatients and for chronic pain in outpatients with CRPS-I or II."

** Evaluation and Diagnosis of People With Pain and Fatigue Syndromes
Conditions: Fatigue; Fibromyalgia; Pain; Complex Regional Pain Syndrome; Reflex Sympathetic Dystrophy
Intervention: No treatment is offered under this protocol. Information collected in this protocol will be used to determine eligibility to other NINR protocols.

** Regional Anesthesia Military Battlefield Pain Outcomes Study
Conditions: Anxiety Disorders; Complex Regional Pain Syndrome Type II; Depressive Disorders; Post-Traumatic Stress Disorder; Substance Abuse
Intervention/Procedure: Regional Anesthesia
Department of Veterans Affairs, Walter Reed Army Medical Center, Brooke Army Medical Center. "Pain management for combat casualties balances emergent, life-saving care with the removal of soldiers from danger. Thus, control of pain may be impossible until safe evacuation to surgical theatres allows for general anesthesia. Recent evidence suggests the hyperstimulation of central neuronal pathways and neural plasticity in the spinal cord and brain leads to neuropathological remodeling and chronic pain in patients with severe acute unrelieved pain. Also, the stress of combat and prolonged uncontrolled pain and suffering contribute to psychological maladjustment and disorders such as PTSD, depression and substance abuse."

*Note: The poster header is kinda antiquated, as far as theory goes. Consider it proof of how far research has come!

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