Biopsychosocial Influence on Shoulder Pain: a Randomized, Pre-clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity
研究概览
简要总结
Chronic shoulder pain is a common, costly, and disabling problem for society. The identification of factors predictive of the development of chronic shoulder pain is necessary to develop innovative and effective treatments to reduce the societal impact of shoulder disorders. In previous work the investigators identified a genetic and psychological subgroup that robustly predicted heightened shoulder pain responses in a pre-clinical cohort and poor 12 month shoulder pain recovery rates in a clinical surgical cohort. In this follow-up study the investigator proposes to test how interventions tailored to the high risk subgroup affect pain responses in a pre-clinical cohort.
The optimal theorized match for the identified high-risk subgroup is a combination of personalized pharmaceutical and education interventions. This combined personalized intervention versus a placebo pharmaceutical and general education intervention group is the primary comparison of interest. Also, an evaluation of the individual effect of personalized pharmaceutical and educational interventions will be part of the study. Such comparisons will provide important information on what the active portion of the combined personalized intervention may be.
详细描述
Potential subjects will be screened and those meeting the high-risk criteria based on COMT genotype for high pain sensitivity and pain catastrophizing questionnaire score will be eligible for randomization into intervention groups (stratified by sex). Exercise induced shoulder injury will serve as the pain generating mechanism on Day 1 and participants will receive pharmaceutical and education interventions over Days 1-4, and Days 2-4 respectively. Statistical analysis will determine whether the combined personalized intervention group experienced shorter shoulder pain duration, lower peak pain intensity, or decreased upper-extremity disability and determine which molecular, psychological, and pain sensitivity regulation mechanisms are associated with pain relief. A preliminary analysis is planned after the first 300 subjects are equally randomized to the 4 intervention groups. The comparison of interest for the preliminary analysis is the combined personalized intervention group with the placebo and general education group for the primary outcome. Depending on the results of this preliminary analysis the randomization pattern may change, with details of these changes available in the protocol paper.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking
排除标准
- •chronic pain (> 3 months) in any area,
- •currently experiencing neck or shoulder pain,
- •previous history of neck or shoulder pain (operationally defined as experiencing neck or shoulder pain for longer than 48 hours or seeking medical treatment for neck or shoulder pain),
- •neurological impairment of the in the upper-extremity (determined by loss of sensation, muscle weakness, and reflex changes),
- •regular participation in upper-extremity weight training,
- •currently or regular use of pain medication, and
- •previous history of upper-extremity surgery.
- •Additional exclusion criteria for propranolol administration are reported history of or presence of any of the following cardiovascular conditions:
- •clinically significant abnormal 12-lead ECG,
- •sinus bradycardia (resting heart rate below 55 beats per minute),
- •greater than first degree heart block,
- •cardiac failure,
- •coronary artery disease,
- •uncontrolled hypertension (resting systolic blood pressure above 140 mm Hg), or hypotension (resting systolic blood pressure below 90 mm Hg),
- •Wolff-Parkinson-White syndrome.
- •Non-cardiovascular reasons for study exclusion include:
- •bronchial asthma,
- •nonallergic bronchospasm,
- •history of recent major surgery requiring general anesthesia,
- •diabetes,
- •pregnancy,
- •major depression.
研究组 & 干预措施
Personalized Pharmaceutical and Education
This group will have propranolol (Propranolol LA) 60 mg administered orally and receive the pain processing education modules as the combined intervention for this arm.
干预措施: Propranolol LA (60 mg) (Drug)
Personalized Pharmaceutical and Education
This group will have propranolol (Propranolol LA) 60 mg administered orally and receive the pain processing education modules as the combined intervention for this arm.
干预措施: Pain Processing Education (Behavioral)
Placebo Pharmaceutical, General Education
This group will have the placebo pharmaceutical administered orally and receive general shoulder anatomy education modules as the interventions for this arm.
干预措施: Placebo (Drug)
Placebo Pharmaceutical, General Education
This group will have the placebo pharmaceutical administered orally and receive general shoulder anatomy education modules as the interventions for this arm.
干预措施: Shoulder Anatomy Education (Behavioral)
Placebo Pharmaceutical, Personalized Education
This group will have the placebo pharmaceutical administered orally and receive the pain processing education modules as the combined intervention for this arm.
干预措施: Placebo (Drug)
Placebo Pharmaceutical, Personalized Education
This group will have the placebo pharmaceutical administered orally and receive the pain processing education modules as the combined intervention for this arm.
干预措施: Pain Processing Education (Behavioral)
Personalized Pharmaceutical, General Education
This group will have propranolol (Propranolol LA) 60 mg administered orally and receive general shoulder anatomy education modules as the interventions for this arm.
干预措施: Propranolol LA (60 mg) (Drug)
Personalized Pharmaceutical, General Education
This group will have propranolol (Propranolol LA) 60 mg administered orally and receive general shoulder anatomy education modules as the interventions for this arm.
干预措施: Shoulder Anatomy Education (Behavioral)
结局指标
主要结局
Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity
时间窗: Approximately 6 days
The outcome has a range between 0 and 1, the higher scores mean a better outcome. Successful recovery was determined based on meeting the recovery criterion for shoulder pain intensity by at least 6 days. Specifically, recovery (Yes or No) was defined using Brief Pain Inventory (BPI) ratings as a current pain intensity rating of 0/10 and a worst pain intensity rating of less than 2/10.
次要结局
- Brief Pain Inventory (BPI) for Pain Duration(Daily until recovery criterion met, approximately 5-15 days)
- Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)(Daily until recovery criterion met, approximately 5-15 days)
- Brief Pain Inventory (BPI) for Worst Shoulder Pain Intensity (Highest Daily Pain Intensity Rating) Recorded During Recovery.(Day 2 value of the worst pain intensity is reported)