Therapeutic Evaluation to Research Clinical Objectives Linking Genotypic and Phenotypic Associations With Pain Management Outcomes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Function/Disability assessment on the Oswestry Disability Index (ODI)
研究概览
简要总结
The purpose of this study is to (a) evaluate the treatment approaches and changes in treatment regimens utilized by clinicians when genetic testing is performed in the clinic; and (b) create a patient data registry to identify genetic factors that influence treatment outcomes in pain management.
详细描述
Clinicians who treat pain have noted that the response to opioids and other pain medications varies widely among patients. Differences in the degree of pain stimulation and pain sensitivity, weight and age differences, prior opioid use and tolerance, as well as the differences in bioavailability of various opioid formulations have been cited as causes for the wide variability in analgesia seen with opioids. However, a significant component of chronic pain may also be explained by genetic polymorphisms. Genetic information may explain the variability of responses and help predict more effective (or less dangerous) treatments and medication choices and doses. By identifying the genetic risks and the most effective analgesic for an individual patient, clinicians may be able to improve the efficacy of the pain treatments and medications and decrease the risk of iatrogenically-induced overdose, addiction, and death.
The purpose of this study is to evaluate how currently available genetic tests are being implemented in a pain management setting and whether this information results in benefits to patient care. Chronic pain patients receiving routine medical visits for their care will complete validated questionnaires to measure pain levels, disability indices, mental health, and quality of life measurements at each clinical visit. Physicians will document any changes made to treatment regimens, including adjustments to medications or non-pharmacological treatments and improvements in pain, functional ratings, or patient satisfaction. Concomitantly, this study will use the collected genetic and clinical data to create a data registry in order to examine novel correlations and associations between single nucleotide polymorphisms and longitudinal datasets.
The results of this study will elucidate potential predictive variables of chronic pain development and/or treatment that will assist in making better healthcare decisions in the selection of treatment modalities and dosing of medications for chronic pain.
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
- •Provide signed and dated informed consent form.
- •Willing to comply with all study procedures and be available for the duration of the study.
- •Currently experiencing a chronic pain problem, with symptoms that have occurred within the last 30 days.
排除标准
- •Severe hepatic or renal disease
- •Significant diminished mental capacity that is unable to understand the protocol, surveys and questionnaires; unable to read/write English or Spanish
- •Recent febrile illness that precludes or delays participation by more than 1 month
- •Pregnancy or lactation
- •Participation in a clinical study that may interfere with participation in this study
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
结局指标
主要结局
Function/Disability assessment on the Oswestry Disability Index (ODI)
时间窗: Up to 2 years
The ODI is used for patients with back or neck pain.
Health-Related Quality of Life assessment on the SF-12v2
时间窗: Up to 2 years
The Short Form 12 item-version 2 (SF-12v2) is a generic assessment of health-related quality of life.
Pain Scores on the CSS-17
时间窗: Up to 2 years
The Chronic Regional Pain Syndrome (CRPS) Severity Score (CSS-17) is used for patients with CRPS.
Changes in type of treatments selected for participants
时间窗: Up to 5 years
Pain Scores on the Pain Numeric Rating Scale (NRS)
时间窗: Up to 2 years
Function/Disability assessment on the Headache Impact Test (HIT-6)
时间窗: Up to 2 years
The HIT-6 is used for patients with headaches or migraines.
Presence and Severity of Depression on the PHQ-2/PHQ-9
时间窗: Up to 2 years
The PHQ-2 is a short screening tool for the PHQ-9.
Changes in medication dosage for the participants
时间窗: Up to 5 years
Changes in the frequency of urine drug screens
时间窗: Up to 5 years
Presence and Severity of Generalized Anxiety Disorder on the GAD-2/GAD-7
时间窗: Up to 2 years
The GAD-2 short screening tool consists of the first two questions of the GAD-7 scale.
Number of Participants that Experience of Adverse Events
时间窗: Up to 5 years
Type of Adverse Events Experienced by Participants
时间窗: Up to 5 years
Severity of Adverse Events Experienced by Participants
时间窗: Up to 5 years
次要结局
- The Session Rating Scale as a measure of the Patient-provider alliance(Up to 2 years)