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Chronic Pain clinical trials

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NCT ID: NCT05555173 Terminated - Chronic Pain Clinical Trials

IVs With Buzzy in Chronic Pain Patients

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The investigators are conducting a study to compare the effectiveness of the Buzzy® device with that of no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions.

NCT ID: NCT05515250 Terminated - Chronic Pain Clinical Trials

Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain

Start date: March 29, 2023
Phase: N/A
Study type: Interventional

Chronic abdominal pain is extremely common in individuals with Cystic Fibrosis (CF). Therapy for chronic abdominal pain is very limited and generally consists of osmotic laxatives or drugs that are used to treat irritable bowel syndrome (IBS), most of which are off-label and not proven to be effective for CF patients. Abdominal pain negatively impacts the quality of life (QOL). With the development of novel therapies for CF, life expectancy has significantly increased. There is, therefore, a critical need to identify treatment pathways for chronic abdominal pain in children with CF. In humans, abdominal pain is modulated by the vagus nerve. Stimulation of the vagus nerve has been suggested to reduce visceral sensitivity and abdominal pain. IB-stim is the Percutaneous Electrical Nerve Field Stimulation (PENS) device. It is a non-invasive, outpatient therapy. PENFS has been shown to be efficacious in pediatric patients with abdominal pain. The FDA has cleared and classified this device as class II, suggesting minimal to moderate risk. There is increasing evidence of intestinal inflammation in patients with CF, which could help explain the GI symptoms and differentiate from IBS. Studies have reported increased inflammation in the intestines using fecal calprotectin. With the implementation of this study, investigators hypothesize that the IB -Stim device will reduce their overall GI inflammation and abdominal pain.

NCT ID: NCT05335980 Terminated - Depression Clinical Trials

Nu-V3 Non-Invasive Nerve Stimulation Device Trial for Chronic Pain, Anxiety, Depression, Sleeplessness

Nu-V3
Start date: April 13, 2018
Phase: N/A
Study type: Interventional

The Nu-V3 Clinical Study is a prospective, single-arm, open-label, multi-center study using the Nu-V3 cranial nerve stimulation treatment device in patients with chronic pain, anxiety, depression, and/or sleeplessness. For this Phase II study, a total of 100-200 patients at multiple centers will be registered for study participation. Study participants are those who have signed the informed consent form, met the inclusion and exclusion criteria, and are enrolled in the study at one of multiple sites. Enrolled participants are stratified based on their chronic pain, anxiety, depression, and/or sleeplessness symptom presentation at baseline and treated with the Nu-V3 device for 24 weeks. Interim analysis of reported data will be based on baseline stratifications and conducted at 6, 12, 18, and 24 weeks during this time. The participant will be evaluated after the initial 12-week treatment period to assess for further therapeutic need. Upon having three consecutive weeks of mean symptom reduction of ≥70% via patient reported numerical scales, the participant will continue as described in the study assessments table, but without device therapy. Then if the participant's primary symptom score increases at any time by ≥20%, they may again continue device therapy until week 24.

NCT ID: NCT05213468 Terminated - Chronic Pain Clinical Trials

Self-management of Chronic Pain Though E-health

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

The investigators aim to validate if a digital tool for increased self-management of chronic pain can improve the quality of life for patients with chronic pain. The validation is based on the change in pain interference (Quality of life), pain intensity, physical functioning, depression, and anxiety based on self-reported information from baseline to study end.

NCT ID: NCT05055622 Terminated - Chronic Pain Clinical Trials

Uncovering Neural and Immune Mechanisms of Chronic Pain in Post Treatment Lyme Syndrome

CP-PTLS
Start date: December 2015
Phase: Phase 2
Study type: Interventional

This study that has the following goals: a) To systematically characterize symptomatology of patients with PTLS by conducting multimodal sensory and neurocognitive assessments and comparing patients with PTLS to healthy controls and to identify biomarkers associated with chronic pain and sensory hypersensitivity among patients with PTLS, c) To investigate whether pharmacologic treatment with milnacipran is associated with clinical improvement chronic pain and physical functioning and with specific changes both in the cerebral and ventricular neurochemistry and in the neural activation patterns d) To investigate whether augmentation with a glutamatergic agent (D-cycloserine) can increase the pain -alleviating effect of an SNRI agent (milnacipran) among patients with PTLS First, patients with chronic PTLS pain and healthy controls will carefully assessed and compared on the brain imaging measures, sensory battery, neuropsychologic tests, and immune markers. After this extensive clinical and neural markers assessment, patients with PTLS and chronic pain will be randomized to (i) 12 weeks of milnacipran +d-cycloserine augmentation, or (ii) 12 weeks of milnacipran + placebo augmentation. Milnacipran (an SNRI) reduces both pain and depression and was shown in previos studies to reduce pain in fibromyalgia. D-Cycloserine (as a glutamate modulator) as a SNRI adjunct was shown to further reduce depression and in animal models to reduce pain. Primary outcome measure will be improvement in pain on visual analog scale, physical functioning and quality of life. All patients will undergo sensory, immune, glycine, self-reports, neuropsychologic testing, and neural markers assessments pre- and post-treatment.

NCT ID: NCT04998734 Terminated - Quality of Life Clinical Trials

Validation of the ASI-SR Form in a Population of Chronic Non-cancer Pain Patients

ASI-SR
Start date: August 5, 2021
Phase:
Study type: Observational

The Swedish version of ASI-SR has shown good feasibility in assessment of addiction patients functioning compare to long and time-consuming ASI, which is upp to date golden standard in Sweden. This study investigate if ASI-SR is suitable instrument for the assessment of the chronic pain patient addicted to opioids. The validation process is designed according to the COSMIN guidelines. Preliminary results are expected by December 2022.

NCT ID: NCT04920630 Terminated - Chronic Pain Clinical Trials

TRAIN Your Sleep; Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

The primary aim of this study is to understand how insomnia contributes to chronic pain in youth. Specifically, the investigators are interested in how insomnia and the treatment of insomnia impact emotional states and the body's ability to efficiently modulate pain, either to increase or decrease pain perception. It is hypothesized that insomnia is associated with increased negative emotional states and impaired pain modulation, which will improve after treatment of insomnia. In this project, the objectives are to 1) evaluate the role of pain modulation as a potential mechanism through which insomnia impacts pain symptoms, and 2) evaluate the role of negative affect as mediators of the impact of insomnia on pain modulation. Study participation will consist of a baseline assessment, a 5 session (once per week) virtual group cognitive behavioral therapy for insomnia (CBT-I) intervention, and a follow-up assessment. Investigators will also ask teen participants to complete the consensus sleep diary daily for 7 days prior to the baseline and follow up study visits. Assessment visits will consist of two types of assessments, questionnaires and quantitative sensory testing (QST). Participating parents and teens will complete questionnaires (both child and parent report) assessing the child's pain, sleep, and psycho-social variables. QST will assess pain inhibition via conditioned pain modulation (CPM) and pain facilitation via temporal summation (TS).

NCT ID: NCT04818814 Terminated - Chronic Pain Clinical Trials

SCI Pain App Intervention Study

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to find out if using an app is a feasible and acceptable treatment for chronic pain in persons with spinal cord injury. Participants will have a 50% chance of being asked to listen to 10 minutes of audio-guided meditations using an app each day for six weeks, and a 50% chance of being asked to listen to 10 minutes of engaging and distracting presentations about topics of interest to the individual (TED Talks) for six weeks. All participants will be asked to complete three online surveys about their emotional and physical health lasting 20-30 minutes (one when the participant first enters the study, one six weeks later, and another six weeks later). Additionally, participants will be asked to complete brief (<5 minute) online surveys once a week during the first six weeks of their participation. Participation in this study is very low risk, and participants may not experience any personal benefit from their participation. Participation in this study is entirely voluntary.

NCT ID: NCT04605744 Terminated - Chronic Pain Clinical Trials

Peri-procedural Smoking Cessation Program in Patients With Chronic Pain

Start date: February 18, 2020
Phase: N/A
Study type: Interventional

This single arm study will assess whether smoking cessation counseling offered to chronic pain patients is effective in reducing pain and cigarette use.

NCT ID: NCT04555239 Terminated - Chronic Pain Clinical Trials

FDM for Subacute and Chronic Extremity Pain in the ED

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

STUDY PURPOSE: To identify whether a low-cost, minimally invasive, one-time manual medicine intervention (fascial distortion model, FDM) is effective for the management of subacute and chronic extremity pain in the emergency department (ED). Demonstration of benefit may have far-reaching implications including reduction of pain medication use in the ED, shortened ED visit times, and future use of this intervention in the outpatient setting for chronic pain management. METHODS: We plan to conduct a randomized, unblinded clinical trial of FDM for the management of subacute and chronic extremity pain. 296 patients ages 18 and older seeking care in the ER for extremity pain that has been present for more than one week and less than three months will be recruited from four emergency departments within the Carilion Clinic hospital network over a 3-year time period. Patients are recruited into the study by treating clinicians in the ER and must describe their pain according to a pattern amenable to treatment with FDM: a. Single point of sharp pain overlying soft tissues correlating to a herniated trigger point; b. Single point of sharp pain overlying bone correlating to a continuum distortion; c. Line or band of pain overlying soft tissues or bone correlating to a trigger band. POPULATION: Adult patients presenting to Carilion Franklin Memorial Hospital (CFMH), Carilion New River Valley Hospital (CNRVH), Carilion Roanoke Memorial Hospital (CRMH), and Carilion Stonewall Jackson Hospital (CSJH). Prisoners and patients with known serious psychiatric comorbidities are specifically excluded. Specific Aims: The primary objective is to determine whether FDM yields significant improvement in function compared with standard care alone. The secondary objective is to determine whether FDM yields significant improvement in pain compared with standard care alone. Our exploratory objective is to determine whether FDM yields clinically significant improvements in pain and function that endure over time. HYPOTHESIS: Patients treated with FDM will demonstrate statistically and clinically significant improvement in function and pain compared with those treated with standard care alone. SIGNIFICANCE: This is the first clinical trial of FDM in the United States and the first in an ED.