Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Reduction of pain in abduction and flexion following the triangular forearm support. maneuver.
研究概览
简要总结
170 patients with rotator cuff syndrome will be filmed abducting and flexing their arms before learning a simple maneuver that alleviates most of the pain 90% of the time. They will then be filmed performing the same abduction and flexion of their arms. The patients will rate their pain on the common 10-point pain scale after abducting and flexing their arms before and after the maneuver.
详细描述
Facial expression and truncal metrics correlate strongly with occurrence and intensity of pain. Rotator cuff syndrome almost invariably gives significant pain, especially with abduction and flexion of the arms. A simple maneuver that alleviates that pain 90% of the time, by activating the subscapularis to perform the function of the damaged supraspinatus muscle. This study strives to correlate facial and truncal characteristics with the ten-point pain scale by correlating the filmed changes in facial and truncal characteristics with the variations in patient-rated pain before and after the pain-controlling maneuver.
Once effective, the maneuver may be repeated for a number of days, after which time patients generally remain pain-free permanently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
After qualifying, patients are randomized into intervention or control groups. The investigator and care provider then film the patient, teach the interventional or sham maneuver, and film the patient again. The outcomes assessor then evaluates the patient responses and filmed behaviors, but is not informed about whether the patient received the interventional maneuver or the sham maneuver.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Rotator cuff syndrome -
排除标准
- •Psychological or emotional instability
- •Other orthopedic conditions of the shoulders
- •Cosmetic facial surgery
研究组 & 干预措施
Interventional
Patients are taught to draw their shoulders away from their heads and necks, activating the subscapularis and pectoralis muscles. When asked immediately afterwards to abduct and flex their shoulders, these muscles perform the action that generally engages the injured supraspinatus muscle, causing significant pain. However, when these muscles are substituted for the injured supraspinatus, abduction and flexion subsequently occur painlessly.
干预措施: Triangular Forearm Support (Behavioral)
Control
Patients are taught a sham maneuver that does little or nothing to alleviate the pain of abduction and flexion of the shoulders. Therefore their pain levels before and after learning the maneuver are likely to be similar.
干预措施: Placebo (Behavioral)
结局指标
主要结局
Reduction of pain in abduction and flexion following the triangular forearm support. maneuver.
时间窗: Outcome measured within 1 minute of intervention
Changes in Likert scale pain scores by patient and examinermaneuver abduction and flexion.
Correlation between facial expression parameters and patient pain-scale ratings
时间窗: Outcome measured within 1 minute of intervention
Changes in facial muscular activity with changes in pain status
次要结局
未报告次要终点