Some people also have no health insurance and a clinical trial may be their sole access to care. Others have intractable levels of CRPS but are still driven to try and help others, and so join in the studies to further scientific inquiry. In studies with a healthy cohort used for comparison, friends and family of CRPSers can also play a helpful role in advancing knowledge of CRPS / RSD.
It's been a while since I've done a Clinical Trials update, using data from the U. S. National Institutes of Health. There are other trials but I tend toward the conservative in these things, as wild as my politics can be. Ahem.
What a shocker to see as a header on the NIH page:
Due to the lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.The next lawmaker (or pseudo-lawmaker) who treats this shutdown as some sort of triviality, think of kids with pediatric cancer who are fighting the clock to stay alive, whose parents are pounding their keyboards searching for options, while these Washington AssHats smugly think this is a political game.
Ahem.
Moving right along. I used some judicious picking and choosing, as some of the options that resulted from my search didn't relate to a CRPSers' concerns.
Surgical Treatment Of Complex Regional Pain Syndrome Type II (CRPS II)
ClinicalTrials.gov Identifier: NCT01392599
Sponsor: Medical University of Vienna
Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS) -- After incision of the skin a subcutaneous area of approximately 16 cm² (2.5 square inches) will be en block removed between dermis and muscle fascia. All prior detected and marked veins in the operating field will be ligated or coagulated precisely.The tissue defect generated by this operation will be closed by a full thickness or a meshed skin graft which arises during the preparation.
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% Lidocain 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.
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Contact: Wolfgang Happak, Prof., MD 00431404006980 lukikriechbaumer@hotmail.com
Contact: Lukas K Kriechbaumer, MD 00431404007177 lukas.kriechbaumer@meduniwien.ac.at
Division of Plastic and Reconstructive Surgery,
Department of Surgery,
Medical University of Vienna
Vienna, Austria, 1090
Two Measures of Tactile Acuity in CRPS Type I Patients
ClinicalTrials.gov Identifier: NCT01888783
Sponsor: Ruhr University of Bochum
Objective: This study aims to investigate whether two different measures of tactile acuity lead to comparable results in patients diagnosed with CRPS Type I of the upper extremity. Additionally patients with a neuropathy of the median nerve and healthy controls are included.
Primary Outcome Measures:
tactile acuity as measured by 2-point-discrimination [ Time Frame: unique measurement of maximal one hour duration ]
Thresholds on the tip of the index finger of boths hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacings are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." Each distance is presented eight times resulting in 64 single decisions. The summed responses are plotted against distance as a psychometric function for absolute threshold and get fitted by a binary logistic regression. Thresholds are taken from the fit at the distance at which 50% correct answers are given
tactile acuity as measured by the Grating Orientation Task (GOT) [ Time Frame: unique measurement of maximal half an hour duration ]
Stimuli are taken from a set of dome-shaped plastic gratings with equal groove and ridge widths. Gratings are applied to the immobilized distal fingerpad of the index finger of boths hand with the ridges oriented either along or across the long axis of the finger in randomized sequences of the two alternatives. Subjects have to report the orientation of the gratings as "along" or "across". The largest groove widths in the set is 6mm, the minimal width is 0.5mm. Thresholds were taken from the groove width at which the performance was 75% correct. Unless the performance is exactly 75% for a particular grating, interpolation between gratings spanning the 75% correct responses ared usedOther Outcome Measures:
Touch threshold for light touch [ Time Frame: unique measurement, duration approx. 5 minutes ]
Touch thresholds are taken from a set of von Frey filaments (0.25 mN - 512 mN). Touch sensitivity is investigated by using a staircase procedure during which subjects are required to close their eyes and report when they perceive an indentation of the skin on the fingerpad of the index finger. The applied forces are decreased in a stepwise manner until the subject no longer perceives the stimulus (lower boundary) and then increased until the stimulus is perceived again (upper boundary). This procedure is repeated 5 times resulting in 10 values that are averaged to provide the touch threshold.Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
Patients diagnosed with CRPS Type I according to the "Budapest Criteria"Exclusion Criteria:
Patients diagnosed with a neuropathy of the median nerve
Healthy Controls,matched in age and gender to both patient cohorts
intolerable hyperalgesia
lesions at the fingertips
high grade digit contracture
central neurologic disorders
psychiatric disorders
Contact: Christoph Maier, Prof. Dr. +49 2343023402 Christoph.Maier@rub.de
Head Dep. of Pain Medicine, Ruhr University of Bochum
Contact: Marianne David, Dr. +49 2343023324 Marianne.David@rub.de
Department of Pain Medicine,
BG Universitätsklinikum Bergmannsheil GmbH
Bochum, Germany, 44789
Effects of Repetitive Electric Sensory Stimulation (RSS) as Intervention in Complex-regional-pain-syndrome Type I (CRPS)
ClinicalTrials.gov Identifier: NCT01915329
Sponsor: Ruhr University of Bochum
The purpose of this study is to test a specific nerve stimulation protocol as therapeutic option in patients diagnosed with CRPS (complex regional pain syndrome) of the upper extremity.
Device: RSS (repetitive sensory stimulation)
Device: SHAM-RSS
Primary Outcome Measures:
static tactile 2-point-discrimination threshold [ Time Frame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post) ]
Thresholds on the tip of the index finger of both hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacings are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." Each distance is presented eight times resulting in 64 single decisions. The summed responses are plotted against distance as a psychometric function for absolute threshold and get fitted by a binary logistic regression. Threshold are taken from the fit at the distance at which 50% correct answers are given.Secondary Outcome Measures:
pain intensity [ Time Frame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post) ]
Pain intensity is rated by the patient on a 11-point numerical rating scale (NRS). Pain intensity is rated before the start of the 5 day stimulation phase (baseline,pre) and at the end (post, in combination with the other outcome measures). Additionally pain intensity is rated directly before the start of each daily stimulation session and immediately after each session of 45 minute duration.Other Outcome Measures:
somatosensory evoked potentials [ Time Frame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post) ]
Somatosensory evoked potentials after electrical paired pulse median nerve stimulation are recorded. The median nerve is stimulated by innocuous paired electrical pulses conveyed to the nerve by a block electrode placed on the wrist. For correct positioning the subject has to report a prickling sensation in thumb, index and middle finger. Stimulation intensity is choosen to induce a small muscular twich at the thenar muscles. SEP recordings are done with a 3-electrode array. Two electrodes are fixed on the scalp over the left and right somatosensory cortex. The third (reference) electrode is fixed over the midfront. SEP signals get amplified and filtered and digitized in a PC.
Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Patients diagnosed with CRPS Type IExclusion Criteria:
intolerable hyperalgesiaLocation: Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
lesions at the fingertips
high grade digit contracture
central neurologic disorders
psychiatric disorders
Bochum, NRW, Germany, 44789
Contact: Christoph Maier, M.D., PhD 0049234302 ext 6366 christoph.maier@rub.de
Contact: Marianne David, Dr. 0049-234-303 ext 3324 Marianne.David@rub.de
RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
ClinicalTrials.gov Identifier: NCT01612364
Sponsor: University of Sao Paulo
Purpose: 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).
Primary Outcome Measures:
Analgesia after block [ Time Frame: 1 month ]
Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.
Secondary Outcome Measures:
analgesia quality of life [ Time Frame: 1 year ]
Experimental: thoracic sympathetic block // Sympathetic block of upper limb via thoracic vertebra T3:
Procedure: thoracic sympathetic block
Thoracic sympathetic block is sympathetic block of upper limb described by Leriche e Fontaine em 1925. The block is performed under radioscopic view, positioning the needle lateral the body of thoracic vertebra T3, where infuse anesthetic solution. The theoretical advantage over the stellate ganglion is its greater specificity and efficiency. Solution block: 5ml ropivacaine 0,75% + 5ml de triamcinolone 2%
Other Names:
T2-T3 thoracic sympathetic block
T3 sympathetic block
T2-T3 thoracic dorsal sympathetic block
thoracic sympathetic ganglion block
thoracic sympathetic block
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
Complex regional pain syndrome (IASP, 1994) involving an upper limb;Exclusion Criteria:
Pain scores in excess of five visual analog scale (VAS);
Poor outcome to treatment (less than 50% reduction in VAS scores)
History of severe brain injury, epilepsy and strokeContact: Roberto O Rocha, MD 551182668553 contato@drrobertorocha.com.br
Patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique
Severe systemic disease
Addictive behavior, severe psychiatric disorders, psychiatric diseases untreated
Refusal to participate or not initial adherence to orientations
Refusal to be randomized in a treatment group or with contraindications to any of them pregnancy.
Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo
Sao Paulo, Brazil, 05403000
Sponsors and Collaborators: University of Sao Paulo; University of Sao Paulo General Hospital
Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
ClinicalTrials.gov Identifier: NCT01623271
Sponsor: Massachusetts General Hospital
Purpose: This research is being conducted to see if the drug Gralise can help people with Complex Regional Pain Syndrom Type I (CRPS I) without causing too many side effects. CRPS I is one of the most common conditions of neuropathic pain (pain that results from damage to nerves in the peripheral nervous system). Gralise is approved by the U.S. Food and Drug Administration (FDA) to treat postherpetic neuralgia (a complication of the disease Shingles, which is caused by the chickenpox virus), but is not approved to treat CRPS I.
Primary Outcome Measures: Visual Analog Scale (VAS) [ Time Frame: 1 year ]
Secondary Outcome Measures:
Functional status [ Time Frame: 1 year ]
Using the SF-MPQ questionnaire we can determine the subject's health and well-being, especially relating to their daily activities.
Side Effect Profile [ Time Frame: 1 year ]
Common side effects include: dizziness, drowsiness, headaches, and swelling in extremities. Other side effects may include suicidal behavior or ideation and depression.
Drop Out Rate [ Time Frame: 1 year ]
Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
Subject will be between 18 to 80 years of age.Exclusion Criteria:
Subject has not been on Gralise.
Subject has not been on gabapentin for at least one month.
Subject agrees to make no change in his/her current pain medications during the study period to ensure that comparisons can be made before and after the Gralise treatment.
Subject has a VAS pain score of 5 or above at the beginning of the study.
Subject has had CRPS I for at least three months to avoid clinical uncertainty and minimize the study variation.
Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit.
Subject has severe liver or renal disease that will affect the elimination of Gralise. (Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs ≥ 3X ULN.)Contact: Trang T. Vo, B.A. 617-724-6102 tvo3@partners.org
Subject has pending litigation related to his/her CRPS I condition.
Subject is pregnant or lactating.
Subject is allergic to gabapentin or Gralise.
Subject has a positive urine (illicit) drug test.
Subject has any history of suicidal thoughts or behaviors, as self reported or in documented medical history.
Subjects with known seizure disorders (except febrile seizures) and/or taking antiepileptic drugs.
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Principal Investigator: Jianren Mao, M.D., Ph.D.
Related Publications Recommended by Study Investigators:
Mao J. Translational pain research: achievements and challenges. J Pain. 2009 Oct;10(10):1001-11. Epub 2009 Jul 22. Review.
ClinicalTrials.gov Identifier: NCT01926119
Sponsor: Stanford University
Purpose: The purpose of this pilot study is to test whether Transcranial Magnetic Stimulation (TMS) may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS in a small pilot study to investigate what methods may have clinical potential. This is a small pilot study to determine feasibility and signal to potentially inform future trials.
Primary Outcome Measures:
Change in pain [ Time Frame: End of each of the 5 treatment sessions and at 1-week follow-up compared to baseline ]
Secondary Outcome Measures:
Change in motor function and coordination [ Time Frame: End of 5-day treatment series and at 1-week follow-up relative to baseline ]
As assessed by functional capacity exam and physical exam
Change in sensory perception [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ]
Change in vasomotor function [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ]
Change in sudomotor function [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ]
Trophic changes [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ]
Change in motor strength and joint range of motion [ Time Frame: End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline ]
Experimental: TMS Intervention - TBS followed by High Frequency
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation
Experimental: TMS Intervention - High frequency stimulation followed by TBS
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of High Frequency stimulation followed by Theta Burst Stimulation
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
Age 18 or olderExclusion Criteria:
Diagnosis of CRPS (complex regional pain syndrome)
Average pain level reported on Numerical Rating Scale meets entry criteria
Ability to perform the experimental task and procedures.
MRI contraindication (metal implants or devices, claustrophobia)Contact: Sean Mackey, MD, PhD smackey@stanford.edu
TMS Contraindication (eg metal implant or devices near the site of stimulation)
History of epilepsy
History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
Neurologic illness that would interfere with brain integrity
Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
Currently pregnant or planning to become pregnant.
On going legal action or disability claim.
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Contact: Rebecca McCue 650-724-2795 snapl@stanford.edu
© 2013 L. Ryan
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