Psychological Treatment of Disability-Related Pain: Efficacy and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Change in average pain intensity pre-treatment to post-treatment
研究概览
简要总结
Many individuals with multiple sclerosis (MS), spinal cord injury (SCI), acquired amputation (AMP), muscular dystrophy (MD), and low back pain (LBP) experience pain. There has been little research on how to treat this pain. Different types of treatment that include self-hypnosis, education about chronic pain, and learning skills on how to change how a person thinks about his/her pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these different treatments can help decrease pain in people with multiple sclerosis and spinal cord injury, and determine how and why these treatments are effective. A subject must have a diagnosis of MS,SCI, AMP, MD, or LBP, have chronic pain, and be at least 18 years old to participate.
详细描述
Individuals from the study's recruitment sources with the diagnoses listed above will be contacted by research staff via telephone and invited to be screened for participation. In addition, individuals interested in participating may contact research staff upon learning about the study through a description listed on an approved website or a referral. Research staff will use a recruitment script for purposes of screening subjects and explaining the study. In addition, the initial screening process will also include conducting a cognitive screening known as the 6-item cognitive screener.
Research staff will verify the diagnoses (MS, SCI, AMP, MD or LBP) of prospective subjects who have not been 'pre-verified' in one of three ways during the recruitment process:
- Research staff will attempt to determine whether a subject from has a University of Washington Medical Center (UWMC)/Harborview Medical Center (HMC) medical record by conducting a simple search using a secure application.
If research staff are unable to locate a medical record for the prospective subject from recruitment strategy #1, or if the individual is part of recruitment strategy #4 (i.e. if individual sees description of study on clinicaltrials.gov and contacts research staff), then one of two options will be pursued: 2. Subjects will be asked during the initial screening process if staff may review their medical records if they have received services at the UWMC/HMC since their diagnosis; 3. Subjects will be asked during the initial screening process if staff may contact a physician of their choice to verify their diagnosis if (a) they have not received services at the UWMC/HMC since their diagnosis; (b) they refuse to give staff permission to review their UWMC/HMC medical records; or (c) staff for some reason cannot find a UWMC/HMC medical record despite the subject attesting to being a patient at one time at the UWMC/HMC and giving staff permission to review his/her records.
Only individuals whose diagnosis has been verified (either via medical record review prior to/during screening or through verification via the subject's physician depending on recruitment source) will proceed with the psychological screening assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •18 years of age or older;
- •diagnosis of SCI, MS, AMP, MD or LBP
- •moderate to severe chronic pain possibly related to MS, SCI, AMP, MD, or LBP that is persistent in nature;
- •able to read, speak, and understand English.
排除标准
- •severe cognitive impairment defined as two or more errors on the Six-Item Screen;
- •psychiatric condition or symptoms that would interfere with participation;
- •Pre-existing medical conditions that might interfere with EEG assessments.
研究组 & 干预措施
Pain Self-Management Arm #1
Pain Self-Management Intervention #1
干预措施: Pain Self-Management Intervention #1 (Behavioral)
Pain Self-Management Arm #2
Pain Self-Management Intervention #2
干预措施: Pain Self-Management Intervention #2 (Behavioral)
Pain Self-Management Arm #3
Pain Self-Management Intervention #3
干预措施: Pain Self-Management Intervention #3 (Behavioral)
Pain Self-Management Arm #4
Pain Self-Management Intervention #4
干预措施: Pain Self-Management Intervention #4 (Behavioral)
结局指标
主要结局
Change in average pain intensity pre-treatment to post-treatment
时间窗: Pre-treatment, Mid-treatment, Post-treatment, 3-,6-, and 12 months following end of treatment.
Average pain intensity will be assessed via telephone interviews using a 0-10 numerical rating scale (NRS) of average pain in the past 24 hours, four times within a 1-week period at each assessment point. The change in mean of these ratings will be used as the primary outcome measure of average daily pain intensity.
次要结局
未报告次要终点
研究者
Mark Jensen
Professor, Rehabilitative Medicine
University of Washington
