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Chronic Pain clinical trials

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NCT ID: NCT06045741 Active, not recruiting - Chronic Pain Clinical Trials

Virtual Reality - A New Vision on Pain

VROP
Start date: September 1, 2023
Phase:
Study type: Observational

The purpose of the project is to investigate if the use of virtual reality (VR) technology with pre-programmed proprietary software can provide better treatment for patients with long-term pain conditions. This is investigated in this pilot study conducted on patients referred to outpatient treatment at the Division of Physical Medicine and Rehabilitation. The pilot study will lay the foundation for a follow-up study (RCT). The effect of VR are evaluated by patient reporting forms; before start-up and 3 months after startup. Patients included in the study receive standard treatment supplemented with the use of VR technology. The therapists involved will be Interviewed to examine their experiences with the use of the VR-technology in the treatment of patients. VR technology can potentially contribute to better treatment (e.g. measured in outcomes such as activity, sleep problems, pain intensity, quality of life). Moreover we expect that a VR-assisted treatment to be more cost-effective and increased availability regardless of geography and demography.

NCT ID: NCT06000007 Active, not recruiting - Chronic Pain Clinical Trials

Digital Therapeutic for Chronic Pain Feasibility Study

Start date: August 25, 2023
Phase: Phase 3
Study type: Interventional

The investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.

NCT ID: NCT05966142 Active, not recruiting - Chronic Pain Clinical Trials

A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic Pain Trial)

ADOPT PGx
Start date: February 10, 2021
Phase: N/A
Study type: Interventional

This study is comprised of three separate pharmacogenetic trials grouped into a single protocol due to similarities in the intervention, the hypotheses, and the trial design. The three trials are the Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial. Participants can enroll in only one of the three trials. All three trials were registered on ClinicalTrials.gov under NCT04445792. In July 2023 each of the three treatment trials was registered under a separate NCT# and NCT04445792 was converted to a screening record per recent guidance on master protocol research programs (MPRPs). This record is specific to the Chronic Pain Trial within the ADOPT-PGx protocol. The Chronic Pain Trial is a prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal.

NCT ID: NCT05917626 Active, not recruiting - Chronic Pain Clinical Trials

Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients

Digital SPA
Start date: May 5, 2023
Phase: N/A
Study type: Interventional

Children and adolescents with chronic pain often lack a proper diagnosis and treatment. Research has shown that, if left untreated, it usually doesn't resolve and continues through adulthood. The goal of this multi-phase study is to co-develop (with patients), test, and implement a smartphone app called "Digital Solution for Pain in Adolescents" (Digital SPA) which can provide pain management resources to children with chronic pain and their parents, preventing future disability. Participants will: participate in individual and group interviews, respond to questionnaires online and try a smartphone app (adolescents) or a website (parents).

NCT ID: NCT05889403 Active, not recruiting - Chronic Pain Clinical Trials

Evaluation of the Patient's Autonomy Vis-à-vis the Therapeutic Project Proposed in a Chronic Pain Structure

DoulEthic
Start date: February 15, 2023
Phase:
Study type: Observational

Patient autonomy is recognized throughout the world, by caregivers, as a value. The idea of autonomy has been the keystone of the changes accomplished in the contemporary history of health law. It is about respect for everyone to have their own health and to choose the options that correspond to their wishes, their values or their life projects. The recently revised definition of pain specifies that it is "an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage". In this, pain is always a personal experience that is influenced to varying degrees by biological, psychological and social factors. The High Authority of Health considers pain as chronic is considered when it is persistent or recurrent beyond what is usual for its presumed initial cause (most often beyond 3 months), that it responds harm to treatment and that they induce a significant and progressive deterioration of functional and relational capacities. Chronic pain confines patients on a psychosocial level. It is no longer just a symptom, it is even a disease in its own right since 2019 with the new classification of diseases proposed by the World Health Organization.In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state". In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state".In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state". In current practice, this skill is assessed in case of doubt (generally when there is uncertainty about the patient's understanding of the issues and his involvement in the therapeutic project) intuitively, by following a Socratic questioning or from grids like the MacCAT-T. In the pain center, investigators use the MacCAT-T but investigators have not yet systematically measured the benefit and the cost of using this questionnaire in everyday practice. In particular, investigators want to know if the skill is not overestimated by the doctor in charge of the patient.

NCT ID: NCT05821530 Active, not recruiting - Chronic Pain Clinical Trials

HFIT Versus TENS Study for Chronic Low Back and Knee Pain

Start date: April 24, 2023
Phase: N/A
Study type: Interventional

A high-frequency impulse therapy (HFIT) device (Enso, San Francisco, CA) is a portable device for the treatment of musculoskeletal pain. This three-arm randomized controlled trial study compares a HFIT group to a standard transcutaneous electrical nerve stimulator (TENS) group and a control group.

NCT ID: NCT05785455 Active, not recruiting - Chronic Pain Clinical Trials

Pain Education, Motivational Interviewing and Exercise in Chronic Neck Pain

COGMO
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Objectives: To evaluate the effectiveness of a complex intervention (COGMO intervention) compared with routine clinical practice in primary care physiotherapy to improve the intensity, severity of pain, and cervical disability in patients with chronic neck pain. Methodology: Design: Pragmatic cluster randomized trial with 12-month follow-up. The unit of randomization is the physiotherapist and the unit of analysis the patient. Scope: Madrid Primary Care health centers. Subjects: Patients 18-65 years old, with neck pain (> 3 months), moderate-severe (>30 mm in visual pain scale). Sample size: 142 patients (71 per branch). Sampling: consecutive of patients who are referred from the family doctor to the Primary Care physiotherapist. Intervention: COGMO Intervention Group (3 components: pain neuroscience communication, motivational interviewing and cognition targeted exercise therapy). Control group: Health education program. Variables: Main: Decrease in intensity of pain: yes / no (> = 30mm on the visual pain scale). Secondary: Related to pain (severity of pain, modulation conditioned to pain, temporal summation, decrease in the disability index, related to psycho-emotional-social aspects: decrease in fear / avoidance behaviour, decrease in kinesiophobia (TSK) and Catastrophism (PCS). Quality of life (Euroqol). Sociodemographic, other treatments, adherence to intervention. Data collection: Baseline visit and 3 follow-up visits (3,6,12 months). Statistical analysis: Intention-to-treat analysis. Difference in the percentage of subjects who achieve success in the main variable at 12 months in the COGMO group compared to control group. A GEE logit model to adjust for other factors.

NCT ID: NCT05782231 Active, not recruiting - Chronic Pain Clinical Trials

Improving Health for Older Adults With Pain Through Engagement (Open-pilot)

iHOPE
Start date: April 18, 2023
Phase: N/A
Study type: Interventional

The goal of this project is to conduct an open-pilot (N=30) to evaluate the feasibility, acceptability, and fidelity of a mind-body and activity program (GetActive+) with older adults with chronic pain. The investigators will test for improvements in self-reported, performance-based (i.e., six-minute walk test), and objective (i.e., step-count) physical function, emotional function, as well as feasibility, acceptability and implementation markers. Participants will complete measures at baseline and post-intervention.

NCT ID: NCT05700383 Active, not recruiting - Chronic Pain Clinical Trials

The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program compared to a health education program for individuals with chronic musculoskeletal pain. The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks. Both programs will be delivered in-person.

NCT ID: NCT05695209 Active, not recruiting - Depression Clinical Trials

Equity Using Interventions for Pain and Depression - Pilot Study

EQUIPD-Pilot
Start date: June 22, 2023
Phase: N/A
Study type: Interventional

This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is part of phase 1 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs). This 2-arm pilot trial will aim to enroll up to 40 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system with the end goal of at least 30 patients completing the trial. After the baseline assessment, patients randomized to the intervention will be asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions will use Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents will be integrated into these sessions, which will facilitate discussion of these options with their PCP. The first 3 sessions take place prior to the patient's next scheduled PCP visit; the final session occurs after this visit. Assessments will be conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months. Patients randomized to the wait-list control group will receive usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they will then be given the DA along with a 20-minute coaching session to walk them through it (patients may decline the coaching session or schedule for a future time).