Pain Management Following Musculoskeletal Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Pain
研究概览
简要总结
Musculoskeletal sprain/strain injuries and disorders (MSID) have a major impact on health, quality of life and societal productivity. Early intervention for pain following acute MSIDs may prevent secondary complications of chronic pain, disability, reduced quality of life or lost productivity. The investigators goal is to evaluate the efficacy of a computer-based self-management intervention for reducing pain and improving function in persons treated in on-site physical rehabilitation centers.
The specific aims are:1) evaluate the efficacy of a computer-based self-management intervention in reducing pain and self-efficacy and function in high risk MSID patients; 2) determine long term impact during a six month follow-up period; and 3) determine whether reductions of pain and improved function translate into reductions in lost work time days away from work, restricted work days, worker's compensation costs and re-injury rates during the 6 month follow-up.
Persons with sprain/strain injuries at risk for poor pain control will randomized to either: 1) control condition - standard care in the rehabilitation center plus computer exposure or 2) standard care plus computer-based self-management pain intervention. Assessment will be at baseline, treatment completion, 3 and 6 months. The primary outcome measures are self-efficacy, pain and physical/psychosocial functioning and secondary outcome measures are days away from work, restricted work days worker's compensation costs and re-injury rates. The investigation will also provide unique and valuable information regarding patients acceptance and use of computer-based interventions following acute injury. By establishing the utility and efficacy of computer-based pain management interventions for MSID the investigators have the potential to improve the health and quality of life of persons with injuries, improve productivity and develop new methods for health care delivery.
详细描述
The proposed study will use a 2 group randomized controlled clinical trial design. The two groups are: 1) standard care in the rehabilitation center with control computer exposure (SCCE) and 2) standard care plus computer-based self-management pain (CBSM) intervention. The study will examine the short- and long-term effects of these interventions on pain and physical and psychosocial functioning and productivity (DAW, RWD, WC costs and re-injury) in 200 completing patients with strain/sprain MSID. Outcome data will be collected at baseline, after treatment, and at 3 and 6 month follow-up. All outcome assessments will be administered by computer.
Pain Management Following Musculoskeletal Injury Study. The study is comprised of two phases: Phase I Planning/Development and Phase II Intervention.
During Phase I Planning/Development, the study investigators 1) identified technology partner to aid in computerization of intervention; 2) identified sites for study implementation; 3) developed consent forms and tracking procedures; 4) developed computer based self-management (CBSM) pain intervention; 5) developed computer based educational materials for the control condition; 6) beta tested intervention materials; 7) developed recruitment materials; 8) developed outcome assessment procedures measures.
During Phase II Intervention, the study investigators will 1)complete IRB review at each of the study sites; 2) train study personnel, and upon approval from each of the IRBs; 3) initiation of study subject recruitment and intervention. Phase II will begin June 2011 and be completed by June 2013.
During Phase II a total of 200 patients will be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •age 18 years or older
- •Musculoskeletal sprain/strain injury
- •pain level greater or equal to 5
- •English speaking
排除标准
- •non-English speaking
研究组 & 干预措施
Computer based pain management
The computer-based self-management program (CBSM) intervention will be administered over 8 sessions during the average 4 week period patients are receiving their standard on-site rehabilitation care. Patients will come to the center to receive their standard care and then interact with the computer for the 25-30 minute CBSM intervention. The primary goals of treatment include developing skills for managing acute injury and related pain including: reducing fear avoidance beliefs and catastrophizing, improving mood, increasing perceptions of control and self-efficacy, maintaining activity and reducing pain. Skills are presented and modeled by computer-based video during sessions, audio will be used to explain models and teach skills such as relaxation training.
干预措施: Computer based pain management (Behavioral)
Education control
The computer exposure will be administered over 8 sessions during the average 4-week period patients are receiving their standard on-site rehabilitation care. Patients will come to the center to receive their standard care and then interact with the computer for the 25-30 minute control condition. The primary goal of this condition is to provide a control for computer exposure. Briefly, the first session will concentrate on establishing the patient's ability to interact with the computer. The materials will provide general education regarding the injury and methods for preventing re-injury. This condition will not provide teaching and practice of specific pain management and coping management skills. This control computer education activity will equalize the computer exposure of the two groups and the duration of time devoted to injury care.
干预措施: Computer based pain management (Behavioral)
结局指标
主要结局
Pain
时间窗: 3 month followup
Pain will be measured using the Brief Pain Inventory, which includes 4 pain items assessing current, worst, least, and average pain (0-no pain to 10-as bad as you can imagine) during the past week. This scale has excellent reliability and validity in a wide variety of acute and chronically painful conditions. In addition to measuring pain severity, 10 items measure pain-related interference in daily activities (0-does not interfere to 10-completely interferes) which also shows excellent reliability and validity in a wide variety of acute and chronically painful conditions.
Physical and Psychosocial Function
时间窗: 3 month followup
The SF-12 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-12 includes items that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. A total score and two subscales scores are calculated -physical function and psychosocial function. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer, self-report, or by telephone.
次要结局
- Work Productivity(3 month followup)