BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 418
- 试验地点
- 9
- 主要终点
- To evaluate the feasibility of assessing the impact of IM intervention on chronic pain
研究概览
简要总结
Preliminary results from an ongoing cross-sectional survey of nine of the BraveNet Outpatient Clinics indicate that pain was the leading reason for patient visits. As a precursor to a large multi-site clinical trial, this study aims to determine the feasibility of collecting outcomes data on integrative treatment for pain. These preliminary data will also provide an estimation of effect size for powering the multi-site clinical trial.
详细描述
Integrative medicine (IM) provides a comprehensive approach to care in which healing and wellness of the whole person are the foremost goals. IM is not simply complementary and alternative medicine (CAM), but it stresses patient-centered, healing-oriented care that emphasizes the patient-caregiver relationship.
Little is known about the health outcomes of patients who present to an IM center and undergo a variety of treatment modalities to treat a specific condition. Adequately capturing and describing IM patient outcomes is a challenge for many reasons. First, given the whole person focus of IM, multiple domains of outcomes must be considered including physical, psychological, social, and spiritual. Second, since the patient-centric notion of individualized care is seminal to IM, IM outcomes must allow for patient-reported outcomes. Finally, the complexity of whole system care creates a natural barrier when measuring IM efficacy. Whole systems of care theoretically rely on synergistic and inseparable components and conceptualize the patient-practitioner interaction as a key component of care.
The Bravewell Integrative Medicine Research Network (BraveNet) is a practice-based research network of nine leading integrative medicine centers around the U.S. collaborating in clinical outcomes research to increase the knowledge and evidence-base of IM. These centers may differ in terms of patient population, medical conditions seen, IM services offered, and treatment outcomes, but all are committed to the provision of integrative care.
Preliminary results from an ongoing cross-sectional survey of nine of the BraveNet Outpatient Clinics indicate that pain was the leading reason for patient visits. As a precursor to a large multi-site clinical trial, this study aims to determine the feasibility of collecting outcomes data on integrative treatment for pain. These preliminary data will also provide an estimation of effect size for powering the multi-site clinical trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be men and women aged 18 and over.
- •Patient Status: Participants are eligible if they are new or existing patients of the center who are seeking their initial treatment at the Integrative Medicine center for chronic pain (chronic > 3 months) who report their average pain level over the past month to be at least a 4 of 10 on the VAS.
- •English or Spanish Literacy: Ability to read and write English or Spanish as confirmed by the site personnel and ability to provide informed consent.
- •Subject must provide written informed consent before initiation of any study-related procedures.
- •Subject must be able to understand and comply with the requirements of the study, as judged by the investigator.
排除标准
- •A subject will not be eligible if he/she is unable to provide Informed Consent.
- •Inability to read and write in English or Spanish.
- •Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the patients risk by participating in the study.
结局指标
主要结局
To evaluate the feasibility of assessing the impact of IM intervention on chronic pain
时间窗: 24 weeks
As measured by the number of patients approached to participate, number who refuse to participate, reasons for refusal, and the number of people who provide consent.
次要结局
- Quality of Life(24 weeks)
- Depression and Stress(24 weeks)
- Inflammatory Marker and Vitamin D(24 weeks)
- Health services utilization(24 weeks)
- Sense of control(24 weeks)
- Work productivity and activity impairment(24 weeks)
- Estimate the effect size of IM interventions for reducing pain in chronic pain patients(24 weeks)