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NCT06432998
The high incidence of gynecological cancers, together with dyspareunia and vaginal stenosis, some of its most frequent sequelae, create the need to continue studying and researching oncological physiotherapy techniques that treat and prevent these sequelae, in order to preserve and/or improve the quality of life of cancer patients. Therefore, through this study, we sought to verify the effectiveness of oncological perineal massage to treat pain during sexual intercourse and vaginal stenosis. The objective of this study will be to demonstrate the effectiveness of a treatment that will consist of a health education session related to the pelvic floor and the consequences related to cancer along with ten sessions of oncological perineal massage that will be carried out for fifty minutes, once a week.
NCT07497451
Cancer-related pain is one of the most common and distressing symptoms experienced by patients with advanced cancer, particularly among women diagnosed with advanced breast cancer. Pain associated with cancer may arise from tumor progression, metastasis, or cancer treatments, and it often has a substantial negative impact on patients' physical functioning, emotional well-being, and overall quality of life. Although pharmacological pain management strategies remain the primary approach for managing cancer-related pain, many patients continue to report inadequate pain relief or experience undesirable side effects from medications. For this reason, healthcare providers and researchers are increasingly exploring complementary and non-pharmacological interventions that can be used alongside standard pain management strategies. Current clinical practice for cancer pain management commonly follows the analgesic ladder recommended by the World Health Organization, which involves a stepwise approach using non-opioid analgesics, weak opioids, and strong opioids depending on the severity of the patient's pain. While this approach has significantly improved pain control in many patients, it does not completely eliminate pain in all cases, and additional supportive interventions are often required. In recent years, digital health technologies such as virtual reality (VR) have emerged as promising tools that may support pain management through distraction, relaxation, and cognitive engagement. Virtual reality is an interactive computer-generated environment that can simulate real or imaginary settings and allow users to experience immersive or semi-immersive sensory stimulation. VR-based interventions have gained increasing attention in healthcare due to their potential to reduce pain perception by diverting attention away from painful stimuli and promoting psychological relaxation. In particular, VR-assisted guided imagery interventions have been proposed as a therapeutic approach that combines visual and auditory stimuli with relaxation techniques to enhance patients' cognitive engagement and emotional comfort. VR technology can be delivered through different levels of immersion. Immersive VR typically uses a head-mounted display to create a fully interactive three-dimensional environment that surrounds the user and blocks out external stimuli, providing a highly engaging experience. In contrast, non-immersive VR systems present virtual environments through computer screens or similar devices, allowing users to remain aware of their physical surroundings while interacting with digital content. Although both approaches may contribute to pain reduction through distraction and relaxation mechanisms, limited evidence exists regarding the comparative effectiveness of immersive versus non-immersive VR interventions in the management of cancer-related pain. Therefore, the purpose of this study is to evaluate the effectiveness of immersive and non-immersive virtual reality-assisted guided imagery interventions in reducing cancer-related pain among patients with advanced breast cancer in Jordan. The study aims to determine whether these interventions can provide additional benefits when used alongside standard cancer pain management practices. This study will employ a quantitative quasi-experimental pre-post design with three study groups: an immersive virtual reality intervention group, a non-immersive virtual reality-assisted guided imagery group, and a control group receiving standard cancer pain management care. Participants in both intervention groups will engage in a 45-minute virtual reality session consisting of guided imagery experiences designed to promote relaxation and distraction from pain. The immersive VR group will use head-mounted display technology to experience a fully immersive 360-degree virtual environment, while the non-immersive VR group will view similar virtual content using a computer-based display system with audio support. Pain intensity will be measured using the Arabic version of the Numerical Pain Rating Scale (NPRS) before the intervention and immediately after the intervention. In addition, symptoms associated with simulator sickness, such as nausea, dizziness, and visual discomfort, will be assessed using the Simulator Sickness Questionnaire (SSQ) to evaluate the safety and tolerability of the VR interventions. The study will be conducted among adult patients diagnosed with advanced breast cancer who are receiving care at a cancer pain management clinic in a large public hospital in Jordan. Eligible participants will be adults aged 18 years or older who are experiencing cancer-related pain and are able to participate in the intervention sessions. A total of 90 participants will be recruited and allocated equally across the three study groups. The findings of this study are expected to contribute to the growing body of evidence regarding the role of virtual reality technologies in suppo
NCT05265052
This study aims to evaluate the safety and efficacy of 3D1002 alone or in combination with oxycodone hydrochloride sustained-release tablets (OxyContin) for the management of moderate or severe cancer pain.
NCT07454083
The goal of this observational study is to evaluate the real-world effectiveness of an acupuncture-first stepped care pathway for pain management in adults aged 18 years and older receiving routine outpatient clinical care for non-cancer-related pain conditions. The primary purpose is to describe episode-based clinical outcomes and care utilization patterns as they occur in standard practice. The main questions it aims to answer are: * What proportion of completed pain episodes achieve a clinically meaningful improvement, defined as a ≥50% reduction in pain intensity (Numeric Rating Scale or Visual Analog Scale) within an episode treatment window of up to 8 acupuncture visits? * What are the visit utilization patterns, time to clinically meaningful improvement, and care escalation patterns within an acupuncture-first stepped care pathway in routine outpatient practice? There is no comparison group. This study does not introduce or test a new intervention. All care is delivered as part of standard clinical practice. Participants will: * Receive acupuncture treatment as part of routine outpatient care * Undergo routine pain assessments (NRS/VAS) at each clinical visit * Participate in standard clinical follow-up as determined by usual care practices No additional research-specific visits, procedures, questionnaires, or interventions are introduced. Data analyzed in this study are derived from routine clinical documentation systems and are de-identified prior to analysis.
NCT05051735
Current guidelines recommend all people with cancer-related pain should be prescribed paracetamol, even those receiving high doses of strong pain killers (opioids) such as morphine. Although this has been shown in studies to be beneficial in other conditions, for instance dental work and after surgery, it has not been shown to further improve pain in people with cancer-related pain. Taking tablets is burdensome to patients and the study aims to determine whether the inconvenience of taking eight extra paracetamol tablets per day can be justified. The study plans to show whether or not pain control is changed (non-inferior) when stopping paracetamol compared to continued use of paracetamol in people already taking strong pain killers for cancer-related pain. Voluntary participants who are taking a combination of paracetamol and a strong opioid are recruited to the study.
NCT07421674
This clinical study aims to understand whether domestic hydromorphinone sustained-release tablets are effective and safe in treating moderate to severe cancer pain in elderly patients with renal insufficiency. It will also understand key safety concerns, especially regarding renal function and neurotoxicity. The main questions it aims to answer include:1. Can hydromorphinone sustained-release tablets effectively relieve the pain of such patients and improve their quality of life?2. During the treatment period, what effect does this drug have on renal function (measured by eGFR)? 3. In this specific population, what are the occurrence and characteristics of neurotoxicity and other side effects induced by opioids? Researchers will compare elderly cancer pain patients with renal insufficiency with those with normal renal function (both receiving the study drug treatment) to observe whether there are differences in efficacy and safety results. Participants will: Receive a standardized treatment plan: First, subcutaneous injection of hydromorphinone injection for dose titration, and then switch to daily oral administration of hydromorphinone sustained-release tablets for 4 weeks. Visit the clinic for assessment and examination (including renal function tests) during the baseline period, on the 7th day, and at the weekends of the 2nd, 3rd, and 4th days. Regularly monitor and record the degree of pain, the occurrence of explosive pain, the use of medication, and any side effects.
NCT04907643
Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain. To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.
NCT07396558
Cancer-related pain is a common and challenging problem in patients with lung cancer, often requiring long-term pain management. Conventional pain treatments, including systemic medications, may not provide adequate relief or may cause significant side effects. The erector spinae plane (ESP) block is a regional anesthesia technique that can help reduce pain by delivering local anesthetic near the nerves supplying the chest wall. This study aims to evaluate the effectiveness and safety of intermittent ESP block administered through a subcutaneous port for controlling cancer-related pain in patients with lung cancer. Eligible patients with lung cancer and moderate to severe pain will receive intermittent ESP block injections via a subcutaneous port as part of their pain management plan. Pain intensity, analgesic requirements, and potential side effects will be assessed over time. The results of this study may help determine whether intermittent ESP block via a subcutaneous port is a useful and feasible option for improving pain control and quality of life in patients with lung cancer.
NCT07265492
The UDOPAL Study proposes an innovative home-based care approach for the management of pain in patients admitted to the Home Hospitalization Unit (UHD). This model incorporates interventional pain management techniques into the clinical practice of home-hospital professionals, supported when necessary by specialists from the Pain Medicine Unit. Pain is a prevalent and often undertreated problem in patients receiving home hospitalization, where complex or oncologic pain may require specialized procedures that traditionally are only performed in hospital settings. The UDOPAL model aims to bridge this gap by providing ultrasound-guided and minimally invasive pain procedures directly at the patient's home, including nerve blocks, infiltrations, and other targeted interventions. This observational, prospective study evaluates the feasibility, safety, and clinical impact of implementing interventional pain management at home. Adult patients with chronic, oncologic, or complex pain will be included. Outcomes include pain intensity, opioid use, functional improvement, quality of life, and patient satisfaction, as well as adverse events related to the techniques. The study seeks to provide scientific evidence supporting a new model of interventional home-based pain care that improves comfort, continuity of care, and efficient use of healthcare resources. The project was approved by the Ethics Committee (CEIm Hospital Universitario y Politécnico La Fe, Acta No. 600, 08/10/2025) and is conducted at Hospital de Manises (Valencia, Spain).
NCT05311774
Cancer pain is one of the most common and problematic symptoms. Opioids are typically the most common drugs used in the treatment of cancer pain,they are limited due to their side effects. Tramadol is a centrally acting non-opiate analgesic with low affinity for μ-opioid receptors, and is effective in the treatment of moderate to severe pain. Neuropathic pain is typically not amenable to standard opiate therapy, and the addition of tricyclic antidepressants or/and antiepileptic drugs can offer a very effective treatment strategy in such patients. Duloxetine is a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) that has been used traditionally for its antidepressant qualities and has also analgesic benefit in the treatment of neuropathic pain. Duloxetine exerts its analgesic action through central and peripheral pain modulation .
NCT06354049
The purpose of this research is to investigate the delivery of Reiki to integrative oncology patients and assess its potential for improving cancer-related symptoms in this population.
NCT05774197
The purpose of this study is to develop and pilot test a novel medical intervention (STAMP+CBT app) that will help patients track their pain, mood, opioid use and side effects while delivering tailored education and self-management advice for patients with advanced cancer.
NCT04095234
The purpose of this study is to compare the long-term effectiveness of acupuncture versus massage in people living with advanced cancer. The study will test how the two approaches compare in helping people with pain and its related symptoms and improving quality of life.
NCT05067556
This is a feasibility pilot trial assessing a behavioral intervention for chronic pain among disease-free cancer survivors to decrease long-term opioid dependence.
NCT07038434
This single-center, non-profit, observational-interventional study aims to develop artificial intelligence (AI) models for the automatic assessment of chronic pain (APA - Automatic Pain Assessment). The study will enroll adult patients with chronic pain of various origins (oncologic and non-oncologic). Participants will undergo multidimensional evaluations that include clinical assessments, self-report questionnaires, bio-signal collection (e.g., EEG, EDA, HRV, GSR, PPG), and facial expression analysis via infrared thermography and video recordings. The primary objective is to calibrate and test machine learning and deep learning models to recognize and predict the presence and severity of pain using multimodal data inputs. Secondary objectives include evaluating the effectiveness of pain treatments, assessing quality of life, and developing a standardized APA dataset for future research. All data collection procedures are non-invasive and safe, and include tools like wearable sensors and standardized neurocognitive tests. The study is approved by the Italian Ethics Committee (Comitato Etico Territoriale Campania 2) and complies with GDPR and EU AI regulations.
NCT07008703
This is a Phase Ib/IIa, multicenter, sequential clinical trial evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SSS40 injection in patients with moderate-to-severe bone metastatic cancer pain. The study includes two stages: a single-arm, open-label, dose-escalation and dose-expansion Phase Ib followed by a randomized, double-blind, placebo-controlled Phase IIa.
NCT05366413
The purpose of the study is to evaluate how feasible and beneficial it is to refer patients with cancer pain to a doctor who specializes in pain management, including procedures to relieve pain, and whether this is helpful to patients with pain related to their cancer.
NCT06791213
According to the International Association for the Study of Pain (IASP), pain is an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage . Despite advances in precision medicine, pain remains a common complaint among cancer patients, with 44.5% reporting pain and a 30.6% prevalence of moderate to severe pain. In Taiwan, over half of cancer patients experience pain in the week leading up to their outpatient visit, with 54% of oncology outpatients reporting pain issues. Of these, only 58% receive analgesics, with more medications given to those with worsening conditions. Pain significantly affects sleep, and over 50% of patients feel pain despite analgesic control. Research indicates that Asian patients often view cancer negatively, avoiding discussions about their condition, which normalizes their pain and potentially worsens it. Enhancing patient self-efficacy can increase satisfaction with pain management, and it is recommended that healthcare professionals develop interventions to improve pain management satisfaction. Self-management interventions have shown effectiveness in improving pain-related knowledge and quality of life. These interventions can encompass patient attitudes and knowledge, with guidance and consultation from nurses reinforcing information about pain management and medication adherence. In clinical settings, nurses may be too busy to provide comprehensive and consistent health education, leading to insufficient patient understanding of medications. Digital multimedia health education tools, which use visual aids, can better capture patients' attention and facilitate unrestricted learning regardless of time or place, leading to improved learning outcomes. This study aims to investigate the effectiveness of "digital multimedia" in reducing pain, enhancing medication adherence, and improving pain control satisfaction among patients. The goal is to overcome the limitations of busy healthcare providers, allowing patients to learn independently, understand pain and analgesic use, dispel myths about pain medications, and enhance pain control, ultimately improving self-care capabilities, pain control satisfaction, and quality of life.
NCT06777004
The study aims to improve the knowledge of pain associated with bone metastases, in particular to analyze the clinical course of patients who are affected by pain due to bone metastases, in order to better understand which factors may be related to a faster response to pain therapy.
NCT05328973
This is a prospective, controlled, randomized trial. Primary objective is to compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo. 70 Eligible subjects will be identified from within the patient population of the study site. There will be no advertisements for study subjects.