"Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation: the NEED LESS PAIN Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Level of Pain
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the efficacy and immunologic effects of a non-pharmacological exercise intervention (push-ups) compared to an oral NSAID (ibuprofen) and an oral placebo to decrease local injection site inflammation symptoms of delayed pain, erythema, and edema and any impact on serologic antibody immune response after influenza vaccine receipt.
详细描述
The study will evaluate the efficacy and immunologic effects of a non-pharmacological exercise intervention (push-ups) compared to an oral NSAID (ibuprofen) and a blinded oral placebo to decrease local injection site inflammation symptoms of delayed pain, erythema, and edema and any impact on serologic antibody immune response after influenza vaccine receipt. A healthy military cohort will be randomly assigned to either perform push-ups consistent with their army physical fitness score, or to take a blinded oral medication which will be an NSAID (ibuprofen) or an oral placebo. The study will require three visits for assessment: on the day of vaccine receipt, 48-72 hours later and 21 -28 days later. The assessment visits will include injection site inspection, an injection site photograph, completion of symptom diaries and a validated pain scale and a laboratory blood specimen at the first and third visit to measure antibody level changes. The exercise participants will also be required to provide 1-2 fingerstick blood samples to evaluate for lactate, which is a byproduct of anaerobic exercise to measure if level of exercise effort achieved anaerobic metabolism. The study will evaluate if either of the interventions impacted perceived delayed pain, physical signs of inflammation or antibody response as measured by serology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be Active Duty Service Members.
- •at least 18 years of age or older.
- •Be requiring and eligible for inactivated influenza vaccine receipt.
- •Be willing and able to complete the study protocol requirements.
- •Have a current Flu Screening Form with medical clearance to receive the influenza vaccination.
排除标准
- •Have already received influenza vaccine for the current season.
- •Have received any type of vaccine in the previous 72 hours.
- •Be on a medical profile resulting in current profile exemption from Physical Training of Upper 2 or Upper
- •(Upper extremity injury or illness)
- •Have preexisting symptoms of injury or infection or other local symptoms that would interfere with site assessment.
- •Be pregnant.
- •Have a history of allergy, intolerance, stomach bleeding or other medical exclusion for ibuprofen.
- •Have a history of stroke or coronary artery disease, such as uncontrolled high blood pressure or abnormal heart beat.
- •Has taken any topical or oral pain medications from the following medication classes in the past 24 hours prior to the start of the study: oral acetaminophen, opioids, tramadol, nonsteroidal anti-inflammatory drug (NSAID) or acetylsalicylic acid (ASA) or topical pain relievers or counterirritants of menthol, methyl salicylate, camphor menthols, and capsaicins.
- •Have any chronic or acute illness or treatment causing immunological suppression such as current oral steroid therapy, malignancy or chemotherapy or lung disease. (not including controlled asthma)
- •Currently participating in any other study
研究组 & 干预措施
Ibuprofen
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
干预措施: Ibuprofen (Drug)
Placebo
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
干预措施: oral placebo (Drug)
Compound Exercise of Push-ups
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
干预措施: Compound Exercise of Push-ups (Behavioral)
结局指标
主要结局
Level of Pain
时间窗: baseline, 48-72 hours and at 21-28 days ( 3 points )
Level of Pain will be measured by validated pain scale, using a scale of 0 ( best, no pain) to 10 (worst, as bad as imaginable, completely interferes).
次要结局
- Serologic Response - A/Hong Kong / 4801/2014(Day 0 and between 21-28 days (2 points))
- Serologic Response - B/Brisbane/60/2008(Day 0 and between 21-28 days (2 points))
- Participants With Edema(baseline, 48-72 hours, and 21- 28 days (3 points))
- Serologic Response - A/California/7/2009(Day 0 and between 21-28 days (2 points))
- Participants With Erythema(baseline, 48- 72 hours, 21-28 days (3 points))
- Serologic Response - B/Phuket/3073/2013(Day 0 and between 21-28 days (2 points))