Immune System and Related DisordersNLPNCT02807623
Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation
A study testing Ibuprofen and Compound Exercise of Push-ups in people with Immune System and Related Disorders, run by Womack Army Medical Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune System and Related Disorders
- What is being tested?
- Ibuprofen and Compound Exercise of Push-ups
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must:
- 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.
Who cannot join
- Must Not:
- 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 3. (Upper extremity injury or illness)
- Have preexisting symptoms of injury or infection or other local symptoms that would interfere with site assessment.
- Be pregnant.
Show all 12Show fewer
- 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
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
About this study
Official title: "Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation: the NEED LESS PAIN Study"
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.
Read the detailed 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.
- Conditions
- Immune System and Related Disorders
- Being tested
- Ibuprofen, Compound Exercise of Push-ups, oral placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Motrin, Advil
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.
Compound Exercise of Push-upsBehavioural
Also called 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.
oral placeboDrug
Also called sugar pill
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.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | 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. Receives: Drug: Ibuprofen |
| Placebo | Placebo comparator | 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. Receives: Drug: oral placebo |
| Compound Exercise of Push-ups | Experimental | Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt. Receives: Behavioral: Compound Exercise of Push-ups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, 48-72 hours and at 21-28 days ( 3 points )
Secondary outcomes (6)
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
Measured: Day 0 and between 21-28 days (2 points)
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
Measured: Day 0 and between 21-28 days (2 points)
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
Measured: Day 0 and between 21-28 days (2 points)
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
Measured: Day 0 and between 21-28 days (2 points)
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.
Measured: baseline, 48- 72 hours, 21-28 days (3 points)
Participants With Edema
Swelling at vaccination site
Measured: baseline, 48-72 hours, and 21- 28 days (3 points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for Immune System and Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Womack Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Laurie A. Housel, MSN,FNP, Principal investigator, Defense Health Agency Immunization Healthcare Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807623
- Sponsor's protocol ID
- 416446
- Acronym
- NLP
- Status last verified
- Nov 2020
- First submitted
- 10 Jun 2016
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Abbott K, Fowler-Kerry S. The use of a topical refrigerant anesthetic to reduce injection pain in children. J Pain Symptom Manage. 1995 Nov;10(8):584-90. doi: 10.1016/0885-3924(95)00086-0.
PubMed 8594118Abuelkheir M, Alsourani D, Al-Eyadhy A, Temsah MH, Meo SA, Alzamil F. EMLA(R) cream: a pain-relieving strategy for childhood vaccination. J Int Med Res. 2014 Apr;42(2):329-36. doi: 10.1177/0300060513509473. Epub 2014 Feb 5.
PubMed 24501164Berberich FR, Landman Z. Reducing immunization discomfort in 4- to 6-year-old children: a randomized clinical trial. Pediatrics. 2009 Aug;124(2):e203-9. doi: 10.1542/peds.2007-3466. Epub 2009 Jul 13.
PubMed 19596729Bruunsgaard H, Hartkopp A, Mohr T, Konradsen H, Heron I, Mordhorst CH, Pedersen BK. In vivo cell-mediated immunity and vaccination response following prolonged, intense exercise. Med Sci Sports Exerc. 1997 Sep;29(9):1176-81. doi: 10.1097/00005768-199709000-00009.
PubMed 9309628Campbell JP, Edwards KM, Ring C, Drayson MT, Bosch JA, Inskip A, Long JE, Pulsford D, Burns VE. The effects of vaccine timing on the efficacy of an acute eccentric exercise intervention on the immune response to an influenza vaccine in young adults. Brain Behav Immun. 2010 Feb;24(2):236-42. doi: 10.1016/j.bbi.2009.10.001. Epub 2009 Oct 8.
PubMed 19818846Chambers CT, Taddio A, Uman LS, McMurtry CM; HELPinKIDS Team. Psychological interventions for reducing pain and distress during routine childhood immunizations: a systematic review. Clin Ther. 2009;31 Suppl 2:S77-S103. doi: 10.1016/j.clinthera.2009.07.023.
PubMed 19781437Cobb JE, Cohen LL. A randomized controlled trial of the ShotBlocker for children's immunization distress. Clin J Pain. 2009 Nov-Dec;25(9):790-6. doi: 10.1097/AJP.0b013e3181af1324.
PubMed 19851160Cohen Reis E, Holubkov R. Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children. Pediatrics. 1997 Dec;100(6):E5. doi: 10.1542/peds.100.6.e5.
PubMed 9374583Das RR, Panigrahi I, Naik SS. The effect of prophylactic antipyretic administration on post-vaccination adverse reactions and antibody response in children: a systematic review. PLoS One. 2014 Sep 2;9(9):e106629. doi: 10.1371/journal.pone.0106629. eCollection 2014.
PubMed 25180516Dilli D, Kucuk IG, Dallar Y. Interventions to reduce pain during vaccination in infancy. J Pediatr. 2009 Mar;154(3):385-90. doi: 10.1016/j.jpeds.2008.08.037. Epub 2008 Oct 11.
PubMed 18849052Doedee AM, Boland GJ, Pennings JL, de Klerk A, Berbers GA, van der Klis FR, de Melker HE, van Loveren H, Janssen R. Effects of prophylactic and therapeutic paracetamol treatment during vaccination on hepatitis B antibody levels in adults: two open-label, randomized controlled trials. PLoS One. 2014 Jun 4;9(6):e98175. doi: 10.1371/journal.pone.0098175. eCollection 2014.
PubMed 24897504Gidudu JF, Walco GA, Taddio A, Zempsky WT, Halperin SA, Calugar A, Gibbs NA, Hennig R, Jovancevic M, Netterlid E, O'Connor T, Oleske JM, Varricchio F, Tsai TF, Seifert H, Schuind AE; Brighton Immunization Site Pain Working Group. Immunization site pain: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2012 Jun 22;30(30):4558-77. doi: 10.1016/j.vaccine.2012.03.085. Epub 2012 Apr 18. No abstract available.
PubMed 22521267Gidudu J, Kohl KS, Halperin S, Hammer SJ, Heath PT, Hennig R, Hoet B, Rothstein E, Schuind A, Varricchio F, Walop W; Brighton Collaboration Local Reactions Working Group for a Local Reaction at or near Injection Site. A local reaction at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2008 Dec 9;26(52):6800-13. doi: 10.1016/j.vaccine.2008.10.006. Epub 2008 Oct 23.
PubMed 18950670Edwards KM, Booy R. Effects of exercise on vaccine-induced immune responses. Hum Vaccin Immunother. 2013 Apr;9(4):907-10. doi: 10.4161/hv.23365. Epub 2013 Jan 14.
PubMed 23319202Edwards KM, Burns VE, Adkins AE, Carroll D, Drayson M, Ring C. Meningococcal A vaccination response is enhanced by acute stress in men. Psychosom Med. 2008 Feb;70(2):147-51. doi: 10.1097/PSY.0b013e318164232e. Epub 2008 Feb 6.
PubMed 18256346
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation: the NEED LESS PAIN Study"
- ClinicalTrials.gov ID
- NCT02807623
- Acronym / sponsor ID
- NLP / 416446
- Conditions
- Immune System and Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Womack Army Medical CenterUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- Sep 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: IbuprofenRandomized 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. |
| Placebo | Placebo comparator | Drug: oral placeboRandomized 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. |
| Compound Exercise of Push-ups | Experimental | Behavioral: Compound Exercise of Push-upsRandomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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 3. (Upper extremity injury or illness)
- Have preexisting symptoms of injury or infection or other local symptoms that would interfere with site assessment.
- Be pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: Motrin, AdvilThe 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. | Drug | Ibuprofen |
| Compound Exercise of Push-upsAlso: Push-upsThe 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. | Behavioural | Compound Exercise of Push-ups |
| oral placeboAlso: sugar pillThe 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. | Drug | Placebo |
Primary outcome
Level of Pain
Time frame: 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).
6 secondary outcomes
Serologic Response - A/California/7/2009
Time frame: Day 0 and between 21-28 days (2 points)
Serologic Response - A/Hong Kong / 4801/2014
Time frame: Day 0 and between 21-28 days (2 points)
Serologic Response - B/Phuket/3073/2013
Time frame: Day 0 and between 21-28 days (2 points)
Serologic Response - B/Brisbane/60/2008
Time frame: Day 0 and between 21-28 days (2 points)
Participants With Erythema
Time frame: baseline, 48- 72 hours, 21-28 days (3 points)
Participants With Edema
Time frame: baseline, 48-72 hours, and 21- 28 days (3 points)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8594118Abbott K, Fowler-Kerry S. The use of a topical refrigerant anesthetic to reduce injection pain in children. J Pain Symptom Manage. 1995 Nov;10(8):584-90. doi: 10.1016/0885-3924(95)00086-0.
- Background: PubMed 24501164Abuelkheir M, Alsourani D, Al-Eyadhy A, Temsah MH, Meo SA, Alzamil F. EMLA(R) cream: a pain-relieving strategy for childhood vaccination. J Int Med Res. 2014 Apr;42(2):329-36. doi: 10.1177/0300060513509473. Epub 2014 Feb 5.
- Background: PubMed 19596729Berberich FR, Landman Z. Reducing immunization discomfort in 4- to 6-year-old children: a randomized clinical trial. Pediatrics. 2009 Aug;124(2):e203-9. doi: 10.1542/peds.2007-3466. Epub 2009 Jul 13.
- Background: PubMed 9309628Bruunsgaard H, Hartkopp A, Mohr T, Konradsen H, Heron I, Mordhorst CH, Pedersen BK. In vivo cell-mediated immunity and vaccination response following prolonged, intense exercise. Med Sci Sports Exerc. 1997 Sep;29(9):1176-81. doi: 10.1097/00005768-199709000-00009.
- Background: PubMed 19818846Campbell JP, Edwards KM, Ring C, Drayson MT, Bosch JA, Inskip A, Long JE, Pulsford D, Burns VE. The effects of vaccine timing on the efficacy of an acute eccentric exercise intervention on the immune response to an influenza vaccine in young adults. Brain Behav Immun. 2010 Feb;24(2):236-42. doi: 10.1016/j.bbi.2009.10.001. Epub 2009 Oct 8.
- Background: PubMed 19781437Chambers CT, Taddio A, Uman LS, McMurtry CM; HELPinKIDS Team. Psychological interventions for reducing pain and distress during routine childhood immunizations: a systematic review. Clin Ther. 2009;31 Suppl 2:S77-S103. doi: 10.1016/j.clinthera.2009.07.023.
- Background: PubMed 19851160Cobb JE, Cohen LL. A randomized controlled trial of the ShotBlocker for children's immunization distress. Clin J Pain. 2009 Nov-Dec;25(9):790-6. doi: 10.1097/AJP.0b013e3181af1324.
- Background: PubMed 9374583Cohen Reis E, Holubkov R. Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children. Pediatrics. 1997 Dec;100(6):E5. doi: 10.1542/peds.100.6.e5.
- Background: PubMed 25180516Das RR, Panigrahi I, Naik SS. The effect of prophylactic antipyretic administration on post-vaccination adverse reactions and antibody response in children: a systematic review. PLoS One. 2014 Sep 2;9(9):e106629. doi: 10.1371/journal.pone.0106629. eCollection 2014.
- Background: PubMed 18849052Dilli D, Kucuk IG, Dallar Y. Interventions to reduce pain during vaccination in infancy. J Pediatr. 2009 Mar;154(3):385-90. doi: 10.1016/j.jpeds.2008.08.037. Epub 2008 Oct 11.
- Background: PubMed 24897504Doedee AM, Boland GJ, Pennings JL, de Klerk A, Berbers GA, van der Klis FR, de Melker HE, van Loveren H, Janssen R. Effects of prophylactic and therapeutic paracetamol treatment during vaccination on hepatitis B antibody levels in adults: two open-label, randomized controlled trials. PLoS One. 2014 Jun 4;9(6):e98175. doi: 10.1371/journal.pone.0098175. eCollection 2014.
- Background: PubMed 22521267Gidudu JF, Walco GA, Taddio A, Zempsky WT, Halperin SA, Calugar A, Gibbs NA, Hennig R, Jovancevic M, Netterlid E, O'Connor T, Oleske JM, Varricchio F, Tsai TF, Seifert H, Schuind AE; Brighton Immunization Site Pain Working Group. Immunization site pain: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2012 Jun 22;30(30):4558-77. doi: 10.1016/j.vaccine.2012.03.085. Epub 2012 Apr 18. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie A. Housel, MSN,FNP principal investigator
Defense Health Agency Immunization Healthcare Branch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen and Compound Exercise of Push-ups in people with Immune System and Related Disorders, run by Womack Army Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Pain (time frame: baseline, 48-72 hours and at 21-28 days ( 3 points )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02807623, which also lists 63 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.