Thursday, January 31, 2013

CRPS: Open Clinical Trials (and those not yet recruiting)

My apologies to CRPS-ers for not having updated recently on Clinical Trials.  Unfortunately, despite the delay in posting, I recognize the continued inclusion of studies that don't seem to have made much progress or perhaps may not be active.  Please perform your own due diligence.

Clinical Trials in Cartoons

***The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture
Condition: Ankle Fracture
Interventions: Dietary Supplement: vitamin c;   Drug: placebo

***Surgical Treatment Of Complex Regional Pain Syndrome Type II (CRPS II) Identifier:  NCT01392599
Condition: CRPS Type II
Sponsor: Medical University of Vienna
Detailed Description:
For 140 years the treatment of Complex Regional Pain Syndromes Type II (CRPS II) has been an unsolved problem. Recent findings in animal models assume that CRPS Type II is maintained by a coupling of newly sprouted sympathetic and sensible fibres. Therapeutic approaches have included conventional pain medication, physical therapy, sympathetic blocks, transcutaneous or spinal cord stimulation, injections or infusion therapies and sympathectomy. Alone or in combination these therapies often yielded unfavorable results. The majority of physicians dealing with CRPS patients are convinced that a surgical treatment of the affected extremity only exacerbates the symptoms, especially its hallmark excruciating pain. 
Patients with a CRPS Type II at the upper or the lower limb will be included in the study after ineffective pain therapy for more than 6 months. The most proximal region of pain associated with CRPS can be localized and 2% Lidocaine will be injected into that area. If the sympathetic, deep, burning pain can be blocked repeatedly with these injections, the subcutaneous veins in the previously determined area will be surgically removed. This operation should lead to the permanent resolution of symptoms. 
A visual analogue scale (VAS), the Nottingham Health Profile (NHP), thermography and physical examinations will be used to evaluate the outcome of the operation.
Contact: Wolfgang Happak, Prof., MD 00431404006980
Contact: Lukas K Kriechbaumer, MD 00431404007177

Suggested Reading for More Information:

--Bruehl S, Harden RN, Galer BS, Saltz S, Bertram M, Backonja M, Gayles R, Rudin N, Bhugra MK, Stanton-Hicks M. External validation of IASP diagnostic criteria for Complex Regional Pain Syndrome and proposed research diagnostic criteria. International Association for the Study of Pain. Pain. 1999 May;81(1-2):147-54.
--Albrecht PJ, Hines S, Eisenberg E, Pud D, Finlay DR, Connolly MK, Paré M, Davar G, Rice FL. Pathologic alterations of cutaneous innervation and vasculature in affected limbs from patients with complex regional pain syndrome. Pain. 2006 Feb;120(3):244-66. Epub 2006 Jan 19.
--Oaklander AL, Rissmiller JG, Gelman LB, Zheng L, Chang Y, Gott R. Evidence of focal small-fiber axonal degeneration in complex regional pain syndrome-I (reflex sympathetic dystrophy). Pain. 2006 Feb;120(3):235-43. Epub 2006 Jan 19.
--Arnold JM, Teasell RW, MacLeod AP, Brown JE, Carruthers SG. Increased venous alpha-adrenoceptor responsiveness in patients with reflex sympathetic dystrophy. Ann Intern Med. 1993 Apr 15;118(8):619-21. No abstract available.
--Baron R, Schattschneider J, Binder A, Siebrecht D, Wasner G. Relation between sympathetic vasoconstrictor activity and pain and hyperalgesia in complex regional pain syndromes: a case-control study. Lancet. 2002 May 11;359(9318):1655-60.
--Drummond PD, Finch PM, Smythe GA. Reflex sympathetic dystrophy: the significance of differing plasma catecholamine concentrations in affected and unaffected limbs. Brain. 1991 Oct;114 ( Pt 5):2025-36.

Conditions: Diabetic Neuropathies; Complex Regional Pain Syndrome Type II;   Resistant Peripheral Neuropathic Pain;  Chemotherapy Induced Pain Neuropathy
Device: TDCS/sham procedure on five consecutive days

***Study of Proteins Associated With Complex Regional Pain Syndrome
Conditions: Complex Regional Pain Syndromes Identifier: NCT00033969
Sponsor:  National Institute of Nursing Research (NINR)
Detailed Description:
The etiology of Complex Regional Pain Syndrome (CRPS) is unknown but a patient typically presents with a triad of clinical findings: sensory abnormalities, perfusion abnormalities and alterations in motor function. Since some of these findings are seen in other disease states, the diagnosis is often not clear. A response to a sympathetic ganglion block (stellate or lumbar) is also suggestive of the disorder. However, there is no definitive diagnostic test for CRPS. Experience has shown that early aggressive treatment improves the prognosis. Therefore, tests that facilitate the early diagnosis would have important clinical implications. 
Advances in laboratory techniques allow analysis of clinical samples to identify protein or patterns of protein changes associated with a disease state. Patients suffering with CRPS who are currently seen in a pain clinic will be asked to participate in this study. The subjects will complete a brief symptom survey, be examined by a co-investigator to document sensory, temperature and trophic changes, and have a blood sample collected for protein and gene expression (RNA) analysis. Blood samples from age-matched controls will be collected from non-CRPS patients. Fifty patient samples collected from each group will be analyzed and used to teach the diagnostic software and an additional 20 samples (10 controls, 10 CRPS patients) will be used to validate diagnostic accuracy.
Contact: Andrew J Mannes, M.D.  (301) 594-7328
Additional Information:  NIH Clinical Center Detailed Web Page
Suggested Reading for More Information:
--Bichsel VE, Liotta LA, Petricoin EF 3rd. Cancer proteomics: from biomarker discovery to signal pathway profiling. Cancer J. 2001 Jan-Feb;7(1):69-78. Review.
--Bittner M, Meltzer P, Chen Y, Jiang Y, Seftor E, Hendrix M, Radmacher M, Simon R, Yakhini Z, Ben-Dor A, Sampas N, Dougherty E, Wang E, Marincola F, Gooden C, Lueders J, Glatfelter A, Pollock P, Carpten J, Gillanders E, Leja D, Dietrich K, Beaudry C, Berens M, Alberts D, Sondak V. Molecular classification of cutaneous malignant melanoma by gene expression profiling. Nature. 2000 Aug 3;406(6795):536-40.
--Chelimsky TC, Low PA, Naessens JM, Wilson PR, Amadio PC, O'Brien PC. Value of autonomic testing in reflex sympathetic dystrophy. Mayo Clin Proc. 1995 Nov;70(11):1029-40.

***Near-infrared Spectroscopic Measurement in Complex Regional Pain Syndrome Identifier: NCT01586377
Condition: Reflex Sympathetic Dystrophy
Sponsor:  Lawson Health Research Institute
Information provided by (Responsible Party): Geoff Bellingham, Lawson Health Research Institute
Detailed Description:

The pathophysiology of CRPS-1 is unknown yet a considerable number of studies suggest that the fundamental cause of abnormal pain is due to microvascular pathology of deep tissues. 
Reduced blood flow to deep tissues such as muscle, nerve, and bone can lead to a combination of inflammatory and neuropathic pain processes (Coderre TJ et al. 2010). Evidence to support this model of microcirculatory dysfunction includes observations that skin capillary oxygenation is decreased and skin lactate is increased in affected limbs of patients (total of 11 patients in lactate study) (Birklein F et al. 2000, Manahan AP et al. 2007). It has also been reported that patients with CRPS-I have abnormal vasodilatory responses after sympathetically-mediated vasoconstriction (Dayan L et al. 2008) and decreased concentrations of nitric oxide in the affected limb (Groeneweg JG et al. 2006). 
Near-infrared spectroscopy (NIRS) is a non-invasive method of measuring tissue oxygenation using the differential absorption properties of oxygenated and deoxygenated hemoglobin in biological tissue (Creteur J 2008). Near-infrared light is only transmitted through small vessels with diameter less than 1 mm (arterioles, venules and capillaries). Since NIRS is limited to monitoring only small vessels, it can be used to assess oxygen balance in the microcirculation of skeletal muscle (Creteur J 2008). 
Premise 1: Complex regional pain syndrome is associated with microcirculatory dysfunction
After an injury to a patient's limb, it is hypothesized that the pressure exerted by that swelling within a relatively confined anatomical space can occlude the capillaries of adjacent tissues and cause a compartment syndrome-like injury. Coderre et al. (2010) have theorized that the resulting microcirculatory dysfunction causes a persistent inflammatory state which is then responsible for pain generation. 
In an animal model of ischemia-reperfusion injury used to study CRPS-1, microscopy of muscle and nerve tissue demonstrates microvascular evidence of a slow-flow/no-reflow phenomenon (Coderre TJ et al. 2010). Existence of a slow-flow/no-reflow state causes persistent inflammation in deep tissue. Animals subsequently develop hyperemia and edema, followed by mechano-hyperalgesia, allodynia, and cold-allodynia lasting for at least 1 month (Coderre et al. 2010). This clinical picture is similar to the clinical signs of those patients afflicted with CRPS-1. 
Premise 2: Vascular occlusion testing measures microcirculatory dysfunction NIRS measurement of peripheral tissue oxygen saturation (StO2), combined with a reproducible ischemia-reperfusion challenge to induce reactive hyperemia (vascular occlusion testing - VOT), has been described as a valid and reliable method for assessing microcirculatory dysfunction (De Backer et al. 2010). This involves a short period of forearm ischemia by inflating a blood pressure cuff on the upper arm. The blood pressure cuff is then released after approximately 3 minutes and this followed by reperfusion of the forearm. This stimulates the release of endogenous nitric oxide (NO) from the microvascular endothelium (Harel et al 2008). Measurement of this hyperemic response using NIRS has been demonstrated to be a feasible non-invasive method of quantifying microcirculatory function. This technique shares strong correlation with the gold-standard method of strain gauge plethysmography (Harel et al. 2008).
Contact: Geoff A Bellingham, MD FRCPC (519) 646-6100 ext 64218
Location: Canada, Ontario
Pain Clinic, St. Joseph's Health Care London Hospitals
London, Ontario, Canada, N6A 4V2

Suggested Reading for More Information:

--Birklein F, Weber M, Neundörfer B. Increased skin lactate in complex regional pain syndrome: evidence for tissue hypoxia? Neurology. 2000 Oct 24;55(8):1213-5.
--Creteur J. Muscle StO2 in critically ill patients. Curr Opin Crit Care. 2008 Jun;14(3):361-6. Review.
--Coderre TJ, Bennett GJ. A hypothesis for the cause of complex regional pain syndrome-type I (reflex sympathetic dystrophy): pain due to deep-tissue microvascular pathology. Pain Med. 2010 Aug;11(8):1224-38. Review.
--Dayan L, Salman S, Norman D, Vatine JJ, Calif E, Jacob G. Exaggerated vasoconstriction in complex regional pain syndrome-1 is associated with impaired resistance artery endothelial function and local vascular reflexes. J Rheumatol. 2008 Jul;35(7):1339-45. Epub 2008 May 1.
--De Backer D, Ospina-Tascon G, Salgado D, Favory R, Creteur J, Vincent JL. Monitoring the microcirculation in the critically ill patient: current methods and future approaches. Intensive Care Med. 2010 Nov;36(11):1813-25. Epub 2010 Aug 6. Review.
--Doerschug KC, Delsing AS, Schmidt GA, Haynes WG. Impairments in microvascular reactivity are related to organ failure in human sepsis. Am J Physiol Heart Circ Physiol. 2007 Aug;293(2):H1065-71. Epub 2007 May 4.
--Groeneweg JG, Huygen FJ, Heijmans-Antonissen C, Niehof S, Zijlstra FJ. Increased endothelin-1 and diminished nitric oxide levels in blister fluids of patients with intermediate cold type complex regional pain syndrome type 1. BMC Musculoskelet Disord. 2006 Nov 30;7:91.
--Harel F, Denault A, Ngo Q, Dupuis J, Khairy P. Near-infrared spectroscopy to monitor peripheral blood flow perfusion. J Clin Monit Comput. 2008 Feb;22(1):37-43. Epub 2007 Nov 27.
--Skarda DE, Mulier KE, Myers DE, Taylor JH, Beilman GJ. Dynamic near-infrared spectroscopy measurements in patients with severe sepsis. Shock. 2007 Apr;27(4):348-53.

***Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb Identifier: NCT01612364
Condition: Complex Regional Pain Syndrome I of Upper Limb
Intervention/Procedure: thoracic sympathetic block
Sponsor: University of Sao Paulo
Collaborator: University of Sao Paulo General Hospital

This is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients with CRPS I refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or control block and then more four physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and WHOQOL-brief).
Contact: Roberto O Rocha, MD 551182668553
Location: Brazil
Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo
Sao Paulo, Brazil, 05403000

***Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
Condition: Complex Regional Pain Syndrome I (CRPS I)
Interventio/Drug: Gabapentin

***Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial Identifier: NCT01118715
Conditions:  Post-traumatic Carpal Tunnel Syndrome; Complex Regional Pain Syndrome; Edema
Intervention/Device: Compression glove

Distal radius fractures (DRF) are the most common type of fracture in the human body, and a large proportion of DRFs result in complications. Previously proposed preventive strategies have questionable efficacy and may impose additional risks on the patient. Because many complications secondary to distal radius fractures are associated with excessive swelling, a prophylactic means for edema reduction could dramatically reduce morbidity among this population. A compression glove is a non-invasive, non-pharmacological way to reduce edema. Previous studies have confirmed its utility in edema reduction after hand trauma and among patients with chronic inflammatory conditions, but none have sufficiently investigated the application to patients with distal radius fractures, a population in which this intervention could have a large impact. The investigators propose a randomized controlled trial to evaluate use of a compression glove during recovery among patients who have sustained an unstable distal radius fracture. The investigators hypothesize that patients who wear a compression glove after a distal radius fracture:
Will experience less edema
Will demonstrate greater functionality
Will recover more quickly
Will have lower incidence rates of carpal tunnel syndrome
Will have lower incidence rates of complex regional pain syndrome
Contact: Michael S Shuler, MD 706-424-8438
Location: United States, Georgia
Athens Orthopedic Clinic
Athens, Georgia, United States, 30606

***Effects of Pennsaid on Clinical Neuropathic Pain Identifier: NCT01508676
Conditions: Neuralgia; Postherpetic Neuralgia;  Reflex Sympathetic Dystrophy; Complex Regional Pain Syndrome (CRPS)
InterventionS/Drug: Pennsaid topical 1.5% diclofenac; Drug: Placebo (2.3% DMSO solution)

Detailed Description:
The research study will compare Pennsaid to placebo. The placebo looks like Pennsaid, but it doesn't contain any Pennsaid. The investigators use placebos in research to see if the results are due to the study drug or to other reasons. At some time during the study the investigators will give the patient Pennsaid. At another time, the investigators will give the patient placebo. The investigators are using Quantitative Sensory Testing (QST), which is temperature testing before and after using the study drug to see if Pennsaid is helpful in reducing people's nerve pain. 
In this test, a small metal plate, about the size of a matchbox, is put on the area where the patient has pain. The plate is connected to a computer that can warm or cool the plate. The patient will use a computer mouse button to tell us when the plate feels warm. The QST machine is approved by the Food and Drug Administration (FDA). It is often used by nerve doctors to see if a person has neuropathy (pain caused by damage to a nerve).
Contact: Abigail S. Cohen, B.A. 617-724-6102
Contact: Trang T. Vo, B.A. 617-724-6102
Location: United States, Massachusetts
MGH Center for Translational Pain Research
Boston, Massachusetts, United States, 02114
Responsible Party: Jianren Mao, MD, PhD, Vice Chair Research, Massachusetts General Hospital

***Spinal Cord Stimulation and Functional MRI Identifier: NCT01512121
Conditions: Complex Regional Pain Syndrome (CRPS);   Neuropathic Leg Pain
The main objective is to define, using functional magnetic resonance imaging, the effects of spinal cord stimulation (SCS) on cortical and subcortical BOLD (Blood Oxygen Level Dependent) effects in patients with neuropathic leg pain. Our hypothesis is that SCS will demonstrate a consistent pattern of BOLD activation that will correlate with symptomatic improvement.
Inclusion Criteria:
Age 18-55 years at time of enrollment.
Have previous implantation of thoracic epidural Medtronic Restore Ultra, Prime Advanced and Restore Advanced SCS in place for the treatment of CPRS-type 1 or chronic refractory neuropathic leg pain following FBSS. The implantation must be 3 or more months prior to enrollment.
Patient must have reported significant pain improvement (>50%) following implantation of the SCS.
Have consistently reproducible pain relief (> 50%) within 10 minutes of switching SCS from an OFF state to an ON state.
The SCS battery is implanted in the buttocks region.
Unilateral or bilateral extremity pain.
Able to provide informed consent.
Exclusion Criteria:
Contraindication to MRI such as: SCS lead in the cervical epidural region Cardiac pacemaker Intracranial aneurysm clips, metallic implants or external clips within 10mm of the head Metallic foreign metals within the orbits Pregnancy; (urine pregnancy test will be done to confirm) Claustrophobia.
Pattern of response to spinal cord stimulation Inconsistent response of pain to spinal cord stimulation Long interval (> 10 minutes) before pain relief following switching SCS from an OFF state to an ON state (with "optimal" parameters) - long "washout" period Lack of significant pain improvement (< 50%) following implantation of SCS
Positive history of significant brain lesions or pathology including:
Prior ablative neurosurgery
History of large vessel strokes or brain tumors
Psychological Screening

Contact: Phuong Nguyen 614-366-6952
Location: United States, Ohio
The Ohio State Medical Center
Columbus, Ohio, United States, 43210
Principal Investigator: Ali Rezai, MD

***Regional Anesthesia Military Battlefield Pain Outcomes Study Identifier: NCT00431847
Conditions: Anxiety Disorders;  Complex Regional Pain Syndrome Type II;  Depressive Disorders;   Post-Traumatic Stress Disorder;  Substance Abuse
Intervention/Procedure: Regional Anesthesia
Detailed Description:
Adequate pain management for combat casualties balances the need for emergent, life-saving care with the urgency to remove soldiers from harm's way. Control of pain in traumatic battlefield situations may be impossible until safe evacuation to a surgical facility is achieved and a wounded soldier can receive general anesthesia. Recent evidence suggests that neural plasticity in the central nervous system coupled with hyperstimulation of central neuronal pathways lead to neuropathological remodeling. This neural rewiring may result in chronic pain for patients who have experienced severe, unrelieved acute pain. In addition, the stress of combat along with the suffering of prolonged uncontrolled pain may contribute to psychological disorders, such as post-traumatic stress disorder, depression, and substance abuse.
The purpose of this study is to evaluate the effect of early and aggressive advanced regional anesthesia on the chronic neuropathic pain, health related quality of life, and mental health of OEF/OIF veterans who have suffered a major limb injury in combat. An additional aim of this study is to quantify and characterize the short-term and long-term effects of traumatic combat limb injuries on post-injury acute pain, chronic pain, health related quality of life, functional status, social reintegration, psychological adjustment, and substance abuse behaviors in a population of injured military personnel.
This study employs a cohort repeated measures study design involving prospective data collection at scheduled intervals. Interviews with participants provide data on pain outcomes, psychiatric morbidities, and quality of life. Follow up evaluations conclude at the two year anniversary of the start of combat injury rehabilitation. Medical records information collected retrospectively from armed services treatment facilities provide data on the use of pain management therapies as well as individual responses to regional anesthesia.
The findings of this study may impact the clinical field by providing information on the effectiveness and benefits of early advanced regional anesthesia for chronic pain control. This study may also provide data to determine whether regional anesthesia pain treatments prevent or reduce the development of psychological maladjustment disorders such as post-traumatic stress disorder, depression, and substance abuse in a population of military personnel with combat limb injuries.

Contact: Yolanda S Williams, MPH (215) 823-5800 ext 2774
Contact: Rollin M Gallagher, MD MPH (215) 823-5800 ext 3399
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Lt. Col. Chester C Buckenmaier III, MD
United States, Pennsylvania
Pain Management Service Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Steven L Martin, BBA     (215) 823-6023  
Contact: Yvette Roberts     (215) 823-5800 ext 6020  
Principal Investigator: Rollin McCulloch Gallagher, MD MPH  
United States, Texas
Brooke Army Medical Center & US Army Institute of Surgical Research Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Brandon Goff, MD  

***Distances From Cricoid Cartilage to the Targets of Stellate Ganglion Block Identifier: NCT01601925
Conditions: Herpes Zoster;   CRPS
Intervention: supine extended position of the neck
Stellate ganglion block targets are C6 transverse process or C7 transverse process in anterior paratracheal approach which is most popular method. Cricoid cartilage is known that it is located at C6 level in supine neutral position of the neck. But stellate ganglion block is performed in supine extended position of the neck. So cricoid cartilage will move up to cephalad direction and pain doctors should find C6 or C7 transverse process at lower neck area than cricoid cartilage.
Contact: Jong B Choi 82-2-2019-6093
Location: Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators: Yonsei University

***Comparison of Methods of Lumbar Sympathetic Ganglion Block: Distance vs Angle Identifier: NCT01648543
Condition: Lumbar Sympathetic Ganglion Block Indication: Neuropathic Pain, CRPS, Hyperhydrosis Etc.
Intervention/Procedure: lumbar sympathetic ganglion block

Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best method of lumbar sympathetic ganglion block is not established. The investigators would compare two methods of lumbar sympathetic ganglion block. One is modified Reid method which's entry point is 7~7.5cm from midline of spinous process of lumbar spine. The other is angular method which's entry angle is 30 degree from anterior-posterior view of C-arm. Comparison modified Reid method with angular method would be helpful for finding best method of lumbar sympathetic ganglion block.

Contact: Jong Bum Choi +82-2-2019-6093
Location: Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators: Yonsei University

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