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Pain, Intractable clinical trials

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NCT ID: NCT03986255 Terminated - Neuropathic Pain Clinical Trials

Identifying Biomarkers and Changes in Cerebrospinal Fluid Collected Pre and Post Spinal Cord Stimulation in Subjects Suffering From Chronic Refractory Pain Conditions

CSF-STIM
Start date: March 19, 2019
Phase: N/A
Study type: Interventional

This is a single center exploratory study in subjects suffering from chronic refractory pain to identify cellular, molecular and protein biomarkers within cerebrospinal fluid (CSF). The study aims to identify any form of correlation between biological content of CSF and pain/treatment success. The study population include individuals suffering from chronic pain which has not been effectively treated with pharmacological treatment, medical intervention or alternative non-invasive treatments who have been scheduled for spinal cord stimulation.

NCT ID: NCT03936205 Completed - Metastatic Cancer Clinical Trials

Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer

Start date: August 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Pain is a common symptom in patients nearing the end of life. Its prevalence varies between 30 and 75%. Nowadays, morphine is the most used molecule as first line treatment of moderate to severe pain. However, this molecule, considering its side effects, may contribute in part to the discomfort of these patients and may increase the pre-existing agitation or delirium. There is therefore a need to find new agents, other than morphine, for pain control at the end of life, without the limitations that the morphine molecule has. The author reviewed the literature on the role of dexmedetomidine in the treatment of refractory symptoms in palliative care, including pain. It is an agonist of the adrenergic alpha 2 receptor having a sedative, analgesic action and a morphine sparing effect demonstrated postoperatively. This study aims primarily at demonstrating that dexmedetomidine has a beneficial role in the treatment of pain in patients with metastatic cancer.

NCT ID: NCT03887494 Not yet recruiting - Hip Fractures Clinical Trials

Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY)

WAZA-ARY
Start date: September 6, 2019
Phase: N/A
Study type: Interventional

Bone metastases appear in many cancers. They are associated with severe pain that is refractory to standard treatment. Improving the quality of life and better pain relief is therefore an essential goal of the treatment of metastatic disease. The most common site of long bone metastases is the superior femoral epiphysis. The usual management of patients with bone metastases in the superior femoral epiphysis is based on gamma implant osteosynthesis when there is a known risk of fracture (Mirels score> 8). Nonetheless this surgery is only accessible to a few patients because of the associated morbidities. Percutaneous cementoplasty has been developed to treat patients who are not eligible for conventional surgery. It consists in a filling of the bone cavity created by metastasis using an acrylic resin. However, these approaches do not completely prevent the risk of upper femoral epiphyseal fracture due to the low mechanical resistance of the resin to shear movements. The Y-STRUT® implantable medical device was developed to overcome this risk of superior femoral epiphyseal fracture by the biomechanical strengthening of the proximal femur in addition to cementoplasty. It has been successfully tested in more than 70 patients with cancer but access to reimbursement and the APHP market have been postponed due to lack of sufficient clinical evidence. The investigators propose this prospective phase 2a study in order to provide evidence of the performance of the Y-STRUT® implant.

NCT ID: NCT03886753 Terminated - Cancer Clinical Trials

Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Ilera Specific Products

Ilera
Start date: May 15, 2019
Phase:
Study type: Observational

This is an observational study of medical marijuana manufactured and dispensed by Ilera and given as standard treatment for a variety of approved serious medical conditions as defined by individual state law. All patients who are receiving one of the four formulations (Dream, Soothe, Shine and Ease) of medical marijuana will be provided a study flyer and asked to contact the study team via phone or email. Once the study team confirms eligibility, the study team will meet the subject face-to-face most likely at their dispensary (or other mutually agreeable location) and obtain informed consent, and assent when appropriate. Initial baseline demographic information, medical history and medication inventory will be completed. Also, since it is possible that the Investigators will enroll subjects across the region, Investigators anticipate the need to seek consent over the phone for many patients. This will be done via Skype, Go to Meeting, Facetime or similar platforms so that the Investigators can have a face to face interaction with the potential subjects. Regardless of where this discussion takes place (i.e., in person or via the web), all reasonable safeguards to ensure patient privacy will be taken. Patients or their legally authorized representative (LAR) will be given sufficient (i.e., up to several hours/days) to make a decision to participate in this study. Study staff will fax or email the consent form for their signature and no study procedures will begin until the signed consent form is received by the study team. The subjects or their LARs will be instructed on obtaining the blood samples. Blood draws will be completed in the subjects' home after one of their standard doses is taken.

NCT ID: NCT03876158 Withdrawn - Chronic Pain Clinical Trials

Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)

TRANSIT
Start date: October 2019
Phase: Phase 4
Study type: Interventional

Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).

NCT ID: NCT03717181 No longer available - Polycystic Kidney Clinical Trials

Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney Disease

Start date: n/a
Phase:
Study type: Expanded Access

Abdominal pain, sometimes severe, is a known symptom of polycystic kidney disease (PKD) related to the cystic expansion. This study will investigate whether the vasopressin V2 receptor antagonist lixivaptan can alleviate intractable pain in a pediatric PKD patient who cannot tolerate the related vasopressin V2 receptor antagonist tolvaptan.

NCT ID: NCT03639415 Withdrawn - Cancer Pains Clinical Trials

Change the Dose Frequency of Controlled-Release Oxycodone to Refractory Pain

Start date: October 30, 2018
Phase: Phase 4
Study type: Interventional

Many patients with cancer experience moderate to severe pain that requires treatment with strong opioids, of which oxycodone and morphine are examples, they are widely applied in clinical treatment because of sustained-released formulation can reduce dosing frequency. Goal of pain management is get adequate analgesia and minimize the adverse event at the same time, but in fact there are about 10%-30% patients can't get adequate analgesia because of intolerable adverse event. The common adverse event of Controlled-Release Oxycodone(CR Oxycodone ) are nausea (29.9%)、constipation (25.4%)、dizziness(22.4%) and vomit(11.9%),about 32.8% patients treatment was discontinued because of these adverse event. The peak concentration of opioid is related to adverse event, while the valley concentration is correlated to the analgesic effect. Therefore, if we keep the daily dose while increase the dose frequency so that reduce the single dose, it's will help to avoid intolerable adverse event caused by excessive opioid peak concentration and keep the opioid analgesia at the same time. It's a reasonable way to solve the side effects of opioid. In order to explore the effect of change the dosing frequency of CR Oxycodone to treat refractory pain, pre-experiment have done by several clinical centrals in Fujian province. Preliminary results show that for the patients who can't accept the current opioid dose because of intolerable side effect, changing the dosing frequency is a safe and effect way.

NCT ID: NCT03470766 Terminated - Neuropathic Pain Clinical Trials

Sham-Controlled RCT on 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (Modulate-LBP)

Modulate-LBP
Start date: August 14, 2018
Phase: N/A
Study type: Interventional

Multicentre, randomised, double-blinded, sham-controlled trial with parallel economic evaluation. Patients will be allocated 1:1 to activated 10kHz SCS plus usual care (intervention) or sham 10kHz SCS plus usual care (control) and followed up to 6 months.

NCT ID: NCT03419312 Active, not recruiting - Low Back Pain Clinical Trials

PET Patterns, Biomarkers and Outcome in Burst SCS Treated FBSS Patients

PET-SCS
Start date: February 11, 2018
Phase: N/A
Study type: Interventional

The primary aim of this study is to investigate cerebral mechanisms of burst stimulation in Failed Back Surgery Syndrome (FBSS) patients treated with Burst Spinal Cord Stimulation (SCS) for chronic back and leg pain. This study is a single center, prospective, blinded, randomized crossover trial with two 14 days treatment periods and two treatment arms (burst before sham stimulation or sham before burst stimulation).

NCT ID: NCT03350256 Completed - Pain, Intractable Clinical Trials

BurstDR™ micrOdosing stimuLation in De-novo Patients

BOLD
Start date: October 30, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.