Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation

Immune System and Related Disorders Clinical Trial

— NLP  

Official title:

"Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation: the NEED LESS PAIN Study"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807623
• Other study ID #: 416446
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2020
• Source: Womack Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Must:

1. Be Active Duty Service Members.

2. at least 18 years of age or older.

3. Be requiring and eligible for inactivated influenza vaccine receipt.

4. Be willing and able to complete the study protocol requirements.

5. Have a current Flu Screening Form with medical clearance to receive the influenza vaccination.

Exclusion Criteria:

Must Not:

1. Have already received influenza vaccine for the current season.

2. Have received any type of vaccine in the previous 72 hours.

3. Be on a medical profile resulting in current profile exemption from Physical Training of Upper 2 or Upper 3. (Upper extremity injury or illness)

4. Have preexisting symptoms of injury or infection or other local symptoms that would interfere with site assessment.

5. Be pregnant.

6. Have a history of allergy, intolerance, stomach bleeding or other medical exclusion for ibuprofen.

7. Have a history of stroke or coronary artery disease, such as uncontrolled high blood pressure or abnormal heart beat.

8. 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.

9. 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)

10. Currently participating in any other study

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Related Conditions & MeSH terms

• Erythema
• Immune System and Related Disorders

Intervention

Drug:
• Ibuprofen
The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.

Behavioral:
• Compound Exercise of Push-ups
The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.

Drug:
• oral placebo
The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Womack Army Medical Center	Fort Bragg	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Womack Army Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

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* Note: There are 63 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lactate	A Lactate meter was used to test the exercise group for lactate readings. Two lactate tests was performed for the exercise group at Visit 1, both pre and post Influenza vaccination. The first lactate reading was taken after the blood draw.The second lactate reading was obtained from a fingerstick from the hand opposite to the vaccination arm, ideally within 3-8 minutes after the study subject completes pushups.	Immediately prior to Influenza vaccine and 3-8 minutes after Influenza vaccine was administered and after push-ups were completed.
Primary	Level of Pain	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).	baseline, 48-72 hours and at 21-28 days ( 3 points )
Secondary	Serologic Response - A/California/7/2009	Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response	Day 0 and between 21-28 days (2 points)
Secondary	Serologic Response - A/Hong Kong / 4801/2014	Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response	Day 0 and between 21-28 days (2 points)
Secondary	Serologic Response - B/Phuket/3073/2013	Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response	Day 0 and between 21-28 days (2 points)
Secondary	Serologic Response - B/Brisbane/60/2008	Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response	Day 0 and between 21-28 days (2 points)
Secondary	Participants With Erythema	Reddening of the skin at vaccination site reported as the total number of participants with erythema over the duration of the study.	baseline, 48- 72 hours, 21-28 days (3 points)
Secondary	Participants With Edema	Swelling at vaccination site	baseline, 48-72 hours, and 21- 28 days (3 points)