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Pain, Intractable clinical trials

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NCT ID: NCT04602286 Completed - Pain, Chronic Clinical Trials

How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Pain Sample)

Start date: October 28, 2020
Phase: N/A
Study type: Interventional

Both mindfulness meditation and expectancy effects are known to reduce pain intensity, pain unpleasantness and pain catastrophizing, but it is unknown whether and how expectancy effects contribute to the overall effect of mindfulness meditation on these outcomes, especially during significant global events such as the coronavirus pandemic. This study includes four interrelated aims that will probe these effects and interactions.

NCT ID: NCT04587674 Recruiting - Pain, Intractable Clinical Trials

Identification of Outcome Predictors and Stratification of Responder Profiles Implanted With Spinal Cord Stimulation. An AI-based-pathway & Algorithmic Approach to Treat Failed Back Surgery Syndrome Patients

PREDIBACK 2
Start date: April 19, 2021
Phase: N/A
Study type: Interventional

Failed Back Surgery Syndrome is commonly defined as new, recurrent, or persistent pain in the back and/or leg(s) of at least 6-month duration following spinal surgery. The literature estimates that 10-50% of patients undergoing spinal surgery are likely to develop such pain, representing a substantial financial burden. Among them, 5-10% would suffer from severe pain, which are intense, neuropathic and generally refractory to conventional therapeutic strategies considerably affect patients' functional capacity as well as their psychological and social well-being. Spinal Cord Stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain such as FBSS. SCS is a safe and reversible treatment option, which leads to improvement in pain relief and quality of life for patients with FBSS. Despite encouraging results in a chronic painful patient population that is refractory to conventional therapies, the literature estimates that only 58% [53% - 64%] of patients implanted with SCS devices achieved adequate pain relief. FBSS population characterization and stratification and predictive modeling of SCS outcome are thus crucial to delineate future treatment options and to deliver neuromodulation therapy to the right patient. The investigators designed a clinical prospective project based on SCS outcome optimization and SCS candidates' stratification: PREDIBACK 2. This study would be a following part of a continuous project (PREDIBACK) that aims to better understand and stratify the therapies (drugs, surgery, psychological therapy or SCS) proposed to FBSS patients. The goal of PREDIBACK 1 was to develop a decision tool that simplifies the therapeutic decision process. PREDIBACK 2 will focus on the neuromodulation pathway. Easing and helping patient orientation should improve referral yielding to specialists and accelerate patient flow through care pathway. Hence, facilitating access to adequate therapies for FBSS patients who usually have a longstanding history of pain.

NCT ID: NCT04572776 Withdrawn - Pain, Intractable Clinical Trials

Phase 3 Study to Assess Resiniferatoxin vs Standard of Care for the Treatment of Intractable Cancer Pain

Start date: December 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care for the treatment of intractable pain associated with cancer.

NCT ID: NCT04503109 Completed - Pain, Chronic Clinical Trials

Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System

nPower™-US
Start date: July 16, 2020
Phase: N/A
Study type: Interventional

The Nalu Neurostimulation System is capable of delivering multiple therapy options to address patient needs. The study will confirm the efficacy, safety, comfort and compliance with the Nalu Neurostimulation System in adult subjects with chronic pain in the legs and back. Patients who have been diagnosed with failed back surgery syndrome (FBSS) and meet other study eligibility criteria will be enrolled in the study to receive the Nalu Neurostimulation System.

NCT ID: NCT04479787 Completed - Neuropathic Pain Clinical Trials

Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)

Start date: July 31, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation, compared with conventional medical management, in improving pain and back-related physical function in subjects suffering with chronic, refractory axial low back pain with a neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an option.

NCT ID: NCT04321408 Recruiting - Refractory Pain Clinical Trials

OP2C : Prialt® Observatory in Clinical Practice

OP2C
Start date: July 10, 2020
Phase:
Study type: Observational [Patient Registry]

Ziconotide (Prialt®) is a powerful analgesic, approved in Europe since 2005, and reserved for the intrathecal route. Ziconotide is a protein of 2500 Daltons isolated from a cone-snail: Conus Magus, acting by blocking the N-type voltage-sensitive calcium channels. Its efficacy has been proven by 3 randomized clinical trials. It is particularly effective on chronic refractory neuropathic pain, and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis. However, during these studies many adverse reactions became evident, especially neuropsychiatric reactions, which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment. There is a lack of data on the current use of ziconotide in current practice. The objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide in different settings of patients with severe chronic pain requiring intrathecal analgesia.

NCT ID: NCT04312685 Enrolling by invitation - Pain Clinical Trials

Transitioning to a Valve -Gated Intrathecal Drug Delivery System

TRANSIT
Start date: July 27, 2020
Phase: N/A
Study type: Interventional

This study is designed to explore if the valve-gated pump requires less drug to manage subject pain than the prior standard peristaltic pump in the same subject. The newly implanted valve-gated pump will be programmed to deliver a minimum dose reduction of 20% of the same medication that was delivered in the peristaltic pump prior to explant. The drug therapy will be evaluated and pain scores will be evaluated over time (3 refill cycles prospectively for the valve-gated pump and 6 months retrospectively for the peristaltic pump).

NCT ID: NCT04096391 Completed - Pain, Chronic Clinical Trials

Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population

Prosper-001
Start date: June 5, 2019
Phase: N/A
Study type: Interventional

This study is being conducted to compare intrathecal morphine using the commercially available intrathecal drug delivery systems (IDDS), and conventional medical management (CMM) in subjects with non-cancer, refractory chronic pain.

NCT ID: NCT04085120 Recruiting - Cancer Pain Clinical Trials

Ropivacaine/Dexamethasone and 10% Lignocaine Injection in GPN Block for Intractable Cancer Pain

Start date: August 23, 2019
Phase: N/A
Study type: Interventional

The study will compare the efficacy and safety of Ropivacaine/dexamethasone vs 10% lignocaine injection in distal glossopharyngeal nerve block for intractable cancer pain

NCT ID: NCT04039633 Recruiting - Erythromelalgia Clinical Trials

Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

Start date: August 26, 2019
Phase: N/A
Study type: Interventional

Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia. The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.