Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Daily Pain Monitoring: 10 point scale
研究概览
简要总结
This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain.
详细描述
This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain. Participants will be randomized to one of these two treatments.
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)
盲法说明
Participant, statistician, and outcomes assessor are blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •report having low back pain for more than three months and at least half the days in the past 6 months
- •be 18-65 years of age,
- •have scores higher than 37 on the Tampa Scale of Kinesiophobia,
排除标准
- •medical conditions other than back pain that significantly impair movement (e.g., arthritis)
- •confirmed/suspected pregnancy
- •pending litigation related to an episode of low back pain
- •significant impairment in vision
研究组 & 干预措施
Interactive Psycho-education
Interactive psycho-education using interactive dashboard.
干预措施: Interactive - Psychoeducation (Behavioral)
Psycho-education
Non-interactive psycho-education not using interactive dashboard.
干预措施: Non-interactive Psychoeducation (Behavioral)
结局指标
主要结局
Daily Pain Monitoring: 10 point scale
时间窗: Baseline - Final assessment (average 1 week post treatment)
Daily pain monitoring defined as daily pain intensity and daily pain interference monitoring is two questions asked daily on a 10 point scale assessing daily pain and how much pain had interfered with day to day activities. Pain: Over the past 24 hours, how would you rate your back pain on average? (0=No Pain; 10=Worst Imaginable Pain) Interference: Over the past 24 hours, how much did pain interfere with your day-to-day activities? (0=No Interference; 10 = A great deal of interference)"
Pain Intensity as assessed by Numeric Rating Scale
时间窗: Baseline - Final assessment (average 1 week post treatment)
The Numeric Rating Scale (NRS) measures pain intensity measured via 0-10 numeric rating scale. 0 = No Pain - 10 = Worst Possible Pain Range of scores: 0-10
Present Pain Intensity
时间窗: Baseline - Final assessment (average 1 week post treatment)
Present Pain Intensity (PPI) assesses present pain intensity on a scale of 0 (no pain) to 5 (excruciating)
Present Pain Rating
时间窗: Baseline - Final assessment (average 1 week post treatment)
Pain Rating Index (PRI) is assessed by 15 questions assessing pain in the sensory and affective dimensions. Items rate from 0 (none) to 3 (severe) on degree to which the words apply to pain. Score Range: 0-45
Pain Chronicity assessed by the Graded Chronic Pain Scale
时间窗: Baseline - Final assessment (average 1 week post treatment)
Pain Chronicity is assessed by the Graded Chronic Pain Scale (GCPS). The GCPS is 7 questions with 3 sub-scales (Characteristic pain intensity, disability score, and disability points). Scoring: Characteristic Pain Intensity: is a 0 to 100 score derived from Questions 1 through 3: Mean (Pain Right Now, Worst Pain, Average Pain) X 10. Disability Score: is 0 to 100 score derived from Questions 4 through 6: Mean (Daily Activities, Social Activities, Work Activities) X 10 Disability Points: Add the indicated points for Disability Days (Question 7) and for Disability Score (0-6). Items rate from 0 to 10 with 0 referencing no pain/interference/change and 10 referencing pain as bad as could be/unable to carry out any activities/extreme change.
次要结局
- Back Disability as assessed by the Roland Morris Disability Questionnaire(Baseline - Final assessment (average 1 week post treatment))
- Daily intervention feedback questions(Baseline - Final assessment (average 1 week post treatment))
- Depressive symptoms as assessed by the Center for Epidemiologic Studies Depression Scale(Baseline - Final assessment (average 1 week post treatment))
- Pain Catastrophizing as assessed by the Pain Catastrophizing Scale(Baseline - Final assessment (average 1 week post treatment))
- Video Game Preferences as assessed by the BrainHex(Final assessment (average 1 week post treatment))
- Mood and Affect as assessed by the Positive and Negative Affect Scale(Baseline - Final assessment (average 1 week post treatment))
- Patient Treatment Evaluation as assessed by the Usefulness, Satisfaction, and Ease of Use Questionnaire(Final assessment (average 1 week post treatment))
- Immersive Tendencies(Baseline only)
- Absorption Tendencies(Baseline Only)
- Video Game History(Baseline Only)
- Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory(Final assessment (average 1 week post treatment))
- Pain-related fear of movement as assessed by the Tampa Scale Kinesiophobia(Baseline - Final assessment (average 1 week post treatment))
- Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale(Final assessment (average 1 week post treatment))
- Patient Treatment Evaluation as assessed by Semi-structured Qualitative interviewing(Final assessment (average 1 week post treatment))
研究者
Zina Trost
Assistant Professor
University of Alabama at Birmingham