A Feasibility Study of Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Retention
研究概览
简要总结
Testing the effect of Virtual Reality - guided imagery acupuncture
详细描述
The aim of this study is to develop a Virtual Reality guided acupuncture imagery treatment system for the treatment of chronic low back pain. This product will provide a new cost-effective treatment option for chronic low back pain and potentially other chronic pain disorders.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers 18-75 years of age.
- •Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
- •At least 4/10 clinical pain on the 11-point LBP intensity scale.
- •Must have had a prior evaluation of their low back pain by a health care provider, which may have included radiographic studies. Documentation of this evaluation will be sought from Partners or outside medical records and kept in the subject's research record.
- •At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
排除标准
- •Specific causes of back pain (e.g. cancer, fractures, infections),
- •Complicated back problems (e.g. prior back surgery, medico legal issues),
- •Possible contraindications for acupuncture (e.g. coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound longitudinal effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
- •Conditions making study participation difficult (eg, paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)
- •The intent to undergo surgery during the time of involvement in the study.
- •Unresolved medical legal/disability/workers compensation claims in connection with low back pain.
- •Lacking the capacity to consent for oneself
- •Do not have access to zoom or other software regularly to complete the study.
研究组 & 干预措施
Virtual Reality - guided acupuncture imagery treatment (VRGAIT)
干预措施: Virtual reality guided imagery acupuncture treatment (VRGAIT) (Other)
Virtual Reality -guided acupuncture imagery treatment (VRGAIT) Control
干预措施: Virtual reality guided imagery acupuncture treatment control (Other)
结局指标
主要结局
Retention
时间窗: Through study intervention, an average of about four weeks
Proportion of subjects who complete all assessments from the total number of subjects who were enrolled in the study
Satisfaction to the Interventions
时间窗: up to 4 weeks
Mean of the satisfaction score on a scale from 1 to 5, larger number indicated greater satisfaction. Assessed after each study interventions, an average score is reported.,
Number of Adverse Events (Safety of the Intervention)
时间窗: Through study interventions, an average of about four weeks
Symptoms and adverse events reported by the participants
次要结局
- PROMIS-29(baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported.)
- Pain Bothersomeness Scale(baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported.)
- MGH Acupuncture Sensation Scale (MASS)(up to 4 weeks.)
- Vividness Scale(After each study interventions, the average score is reported.)
研究者
Lucy Chen
Principal investigator
Massachusetts General Hospital