PainNCT02679534
The Effectiveness of Hand Massage on the Pain of Cardiac Surgery Critically Ill
A study testing hand massage, hand holding and application of unscented hypoallergenic cream in people with Pain, run by McGill University at 1 site in Canada.
Trial summary
Postoperative pain is a common phenomenon in the intensive care unit (ICU) despite the multitude of efforts dedicated to promote its effective relief. Mounting evidence shows that cardiac surgery ICU patients experience moderate to severe pain reaching proportions as high as 74% despite the use of analgesics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- hand massage, hand holding and application of unscented hypoallergenic cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to speak French or English
- elective cardiac surgery requiring sternal incision (e.g., coronary artery bypass graft, valve replacement)
- able to answer questions and self-report symptoms
Who cannot join
- previous cardiac surgery
- diagnostic of cognitive or psychiatric disorder
- pulmonary artery pressure >50 mmHg
- right ventricular failure
- systolic left ventricular dysfunction (ejection fraction 35% or less)
- body mass index > 30
Show all 12Show fewer
- prolonged bleeding from the chest drainage tubes (i.e., >200 ml/h)
- having mechanical blood pressure support (e.g., intra-aortic balloon pump)
- receiving cardiac pacing with complete control of HR
- peripheral intravenous line in the hands
- suppurating/infective/inflammatory skin condition of the hands
- hypersensitivity to touch.
Trial locations and contacts
1 site in 1 country.
Madalina Boitor, PhD(C) contact
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Madalina Boitor, PhD (c), madalina.boitor@mcgill.ca
About this study
Official title: The Effectiveness of Hand Massage on the Pain of Cardiac Surgery Critically Ill- A Randomized Controlled Trial
Postoperative pain is a common phenomenon in the intensive care unit (ICU) despite the multitude of efforts dedicated to promote its effective relief. Mounting evidence shows that cardiac surgery ICU patients experience moderate to severe pain reaching proportions as high as 74% despite the use of analgesics. The highest pain intensity is experienced in the first 24 hours post surgery when patients are still in the ICU, and represents a strong predictor for the presence and severity of persistent postoperative pain. To maximize pain relief, massage has been suggested in the recent clinical practice guidelines of the Society of Critical-Care Medicine as a complementary non-pharmacological therapy in the ICU given its opioid-sparing and analgesia-enhancing potential. Some randomized controlled trials showed promising pain relief effects of massage when administered to cardiac surgery patients in acute care units, however, its effects on pain relief while patients are still in the ICU and when pain severity is highest remain unknown.
This study aims to compare the effect of three 20-minute hand massage administrations within 24 hours postop on the pain intensity (primary outcome), pain unpleasantness, pain interference, muscle tension, anxiety and vital signs (blood pressure, heart and respiratory rates) of adult intensive care unit (ICU) patients post cardiac surgery versus hand holding (i.e., simple touch) and standard care. Other objectives are to describe the location and quality of pain of cardiac surgery ICU patients.
Read more
Hypothesis:
Patients receiving 3 hand massages within 24 hours postop will have lower pain intensity, unpleasantness and interference, muscle tension, anxiety and vital signs compared to patients receiving hand holding and to those in the standard care group.
- Conditions
- Pain
- Being tested
- hand massage, hand holding, application of unscented hypoallergenic cream, environmental adjustments
- Keywords
- pain, thoracic surgery, massage
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand massageOther
hand holdingOther
application of unscented hypoallergenic creamOther
environmental adjustmentsOther
| Study group | Role | What they receive |
|---|---|---|
| hand massage | Experimental | Patients will receive a 20 minute hand massage by a trained nurse in addition to the standard ICU care. Before administering the massage, a favorable environment will be created that promotes calmness such as dampening the light, reducing the alarm intensity, closing the curtains and the door and posting the notice "do not disturb", and a comfortable positioning of the patient will be ensured. The interventionist will hold each hand for 5-10 seconds, and apply 5-10 ml of unscented hypoallergenic cream to both hands and wrists. Then, she will perform massage using moderate pressure, and the stroking and kneading techniques during ten minutes on the palm and back of each hand. Receives: Other: hand massage; Other: application of unscented hypoallergenic cream; Other: environmental adjustments |
| hand holding | Active comparator | The active control group will receive hand holding by the same trained nurse in addition to standard ICU care. The same hand hygiene and environmental adjustments will be made as for those receiving massage. Patients will have their hands held for 5-10 seconds and unscented hypoallergenic cream applied to both hands. Then, the interventionist will hold each of the patients' hand in her hand for ten minutes without performing any tissue manipulation. The hand holding procedure will last for a total of 20 minutes. Receives: Other: hand holding; Other: application of unscented hypoallergenic cream; Other: environmental adjustments |
| rest group | Other | The passive control group will have a 20 minutes rest period including the same environmental adjustments as the massage and hand holding groups in addition to the standard care administered in the ICU. The standard care includes the pharmacological and non-pharmacological treatments used to promote recovery and symptom relief. In the study ICU, cardiac surgery patients are automatically prescribed a pain management protocol that includes the regular administration of morphine, unless extraordinary patient circumstances require different prescriptions. Patients might equally receive breakthrough doses of analgesia in addition to regular opioids. Of the existing non-pharmacological interventions, repositioning and back rubs are commonly employed in the study ICU to provide patient comfort. Receives: Other: environmental adjustments |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Pain intensity will be captured using the 0 to 10 Numeric Rating Scale score, and the analysis metric will be the change in pain intensity from baseline (pre-intervention) to immediately after each intervention. For each study group, means and standard deviations of patients' pain intensity levels will be reported.
Change in pain intensity levels will be assessed for each of the three interventions administered within 24 hours postop.
Measured: before and immediately after each intervention within 24 hours postoperatively
Secondary outcomes (14)
change in pain unpleasantness from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Measured: before and immediately after each intervention within 24 hours postop
change in muscle tension from pre- to post-intervention by performing passive flexion and extension of patient's arm, and scoring 0 (relaxed), 1 (tense) or 2 (very tense/rigid)
The muscle tension ordinal scale 0-2 is based on the muscle tension item of the Critical-Care Pain Observation Tool, a behavioral pain scale for the assessment of pain in the non-verbal critically ill.
Measured: before and immediately after each intervention within 24 hours postop
change in anxiety from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Measured: before and immediately after each intervention within 24 hours postop
changes in 1-minute blood pressure average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor
Measured: before and immediately after each intervention within 24 hours postop
changes in 1-minute heart rate average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor
Measured: before and immediately after each intervention within 24 hours postop
changes in 1-minute respiratory rate average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor
Measured: before and immediately after each intervention within 24 hours postop
pain interference as assessed using the Brief Pain Inventory
Measured: on the second and fourth postoperative days
change in pain intensity from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
Measured: immediately after each intervention and 30 minutes later within 24 hours postop
change in pain unpleasantness from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
Measured: immediately after each intervention and 30 minutes later within 24 hours postop
change in muscle tension from post-intervention to 30 minutes later by performing passive flexion and extension of patient's arm, and scoring 0 (relaxed), 1 (tense) or 2 (very tense/rigid)
Measured: immediately after each intervention and 30 minutes later within 24 hours postop
change in anxiety from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
Measured: immediately after each intervention and 30 minutes later within 24 hours postop
changes in 1-minute blood pressure average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor
Measured: immediately after each intervention and 30 minutes later within 24 hours postop
changes in 1-minute heart rate average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor
Measured: immediately after each intervention and 30 minutes later within 24 hours postop
changes in 1-minute respiratory rate average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor
Measured: immediately after each intervention and 30 minutes later within 24 hours postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Céline Gélinas, McGill University
- Investigators
- Celine Gelinas, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679534
- Sponsor's protocol ID
- 15-186
- Status last verified
- Apr 2016
- First submitted
- 3 Feb 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
Publications
Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
PubMed 23269131Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.
PubMed 20347836Braun LA, Stanguts C, Casanelia L, Spitzer O, Paul E, Vardaxis NJ, Rosenfeldt F. Massage therapy for cardiac surgery patients--a randomized trial. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1453-9, 1459.e1. doi: 10.1016/j.jtcvs.2012.04.027. Epub 2012 Sep 7.
PubMed 22964355Boitor M, Martorella G, Laizner AM, Maheu C, Gelinas C. The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol. JMIR Res Protoc. 2016 Nov 7;5(4):e203. doi: 10.2196/resprot.6277.
PubMed 27821384
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Hand Massage on the Pain of Cardiac Surgery Critically Ill- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02679534
- Acronym / sponsor ID
- 15-186
- Conditions
- Pain
- Keywords
- pain, thoracic surgery, massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain is a common phenomenon in the intensive care unit (ICU) despite the multitude of efforts dedicated to promote its effective relief. Mounting evidence shows that cardiac surgery ICU patients experience moderate to severe pain reaching proportions as high as 74% despite the use of analgesics. The highest pain intensity is experienced in the first 24 hours post surgery when patients are still in the ICU, and represents a strong predictor for the presence and severity of persistent postoperative pain. To maximize pain relief, massage has been suggested in the recent clinical practice guidelines of the Society of Critical-Care Medicine as a complementary non-pharmacological therapy in the ICU given its opioid-sparing and analgesia-enhancing potential. Some randomized controlled trials showed promising pain relief effects of massage when administered to cardiac surgery patients in acute care units, however, its effects on pain relief while patients are still in the ICU and when pain severity is highest remain unknown.
This study aims to compare the effect of three 20-minute hand massage administrations within 24 hours postop on the pain intensity (primary outcome), pain unpleasantness, pain interference, muscle tension, anxiety and vital signs (blood pressure, heart and respiratory rates) of adult intensive care unit (ICU) patients post cardiac surgery versus hand holding (i.e., simple touch) and standard care. Other objectives are to describe the location and quality of pain of cardiac surgery ICU patients.
Hypothesis:
Patients receiving 3 hand massages within 24 hours postop will have lower pain intensity, unpleasantness and interference, muscle tension, anxiety and vital signs compared to patients receiving hand holding and to those in the standard care group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hand massage | Experimental | Other: hand massage, Other: application of unscented hypoallergenic cream, Other: environmental adjustmentsPatients will receive a 20 minute hand massage by a trained nurse in addition to the standard ICU care. Before administering the massage, a favorable environment will be created that promotes calmness such as dampening the light, reducing the alarm intensity, closing the curtains and the door and posting the notice "do not disturb", and a comfortable positioning of the patient will be ensured. The interventionist will hold each hand for 5-10 seconds, and apply 5-10 ml of unscented hypoallergenic cream to both hands and wrists. Then, she will perform massage using moderate pressure, and the stroking and kneading techniques during ten minutes on the palm and back of each hand. |
| hand holding | Active comparator | Other: hand holding, Other: application of unscented hypoallergenic cream, Other: environmental adjustmentsThe active control group will receive hand holding by the same trained nurse in addition to standard ICU care. The same hand hygiene and environmental adjustments will be made as for those receiving massage. Patients will have their hands held for 5-10 seconds and unscented hypoallergenic cream applied to both hands. Then, the interventionist will hold each of the patients' hand in her hand for ten minutes without performing any tissue manipulation. The hand holding procedure will last for a total of 20 minutes. |
| rest group | Other | Other: environmental adjustmentsThe passive control group will have a 20 minutes rest period including the same environmental adjustments as the massage and hand holding groups in addition to the standard care administered in the ICU. The standard care includes the pharmacological and non-pharmacological treatments used to promote recovery and symptom relief. In the study ICU, cardiac surgery patients are automatically prescribed a pain management protocol that includes the regular administration of morphine, unless extraordinary patient circumstances require different prescriptions. Patients might equally receive breakthrough doses of analgesia in addition to regular opioids. Of the existing non-pharmacological interventions, repositioning and back rubs are commonly employed in the study ICU to provide patient comfort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to speak French or English
- elective cardiac surgery requiring sternal incision (e.g., coronary artery bypass graft, valve replacement)
- able to answer questions and self-report symptoms
Key exclusion criteria (12 listed)
- previous cardiac surgery
- diagnostic of cognitive or psychiatric disorder
- pulmonary artery pressure >50 mmHg
- right ventricular failure
- systolic left ventricular dysfunction (ejection fraction 35% or less)
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 |
|---|---|---|
| hand massage | Other | hand massage |
| hand holding | Other | hand holding |
| application of unscented hypoallergenic cream | Other | hand holding, hand massage |
| environmental adjustments | Other | hand holding, hand massage, rest group |
Primary outcome
change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Time frame: before and immediately after each intervention within 24 hours postoperatively
Pain intensity will be captured using the 0 to 10 Numeric Rating Scale score, and the analysis metric will be the change in pain intensity from baseline (pre-intervention) to immediately after each intervention. For each study group, means and standard deviations of patients' pain intensity levels will be reported. Change in pain intensity levels will be assessed for each of the three interventions administered within 24 hours postop.
14 secondary outcomes
change in pain unpleasantness from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Time frame: before and immediately after each intervention within 24 hours postop
change in muscle tension from pre- to post-intervention by performing passive flexion and extension of patient's arm, and scoring 0 (relaxed), 1 (tense) or 2 (very tense/rigid)
Time frame: before and immediately after each intervention within 24 hours postop
change in anxiety from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Time frame: before and immediately after each intervention within 24 hours postop
changes in 1-minute blood pressure average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor
Time frame: before and immediately after each intervention within 24 hours postop
changes in 1-minute heart rate average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor
Time frame: before and immediately after each intervention within 24 hours postop
changes in 1-minute respiratory rate average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor
Time frame: before and immediately after each intervention within 24 hours postop
pain interference as assessed using the Brief Pain Inventory
Time frame: on the second and fourth postoperative days
change in pain intensity from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
Time frame: immediately after each intervention and 30 minutes later within 24 hours postop
change in pain unpleasantness from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
Time frame: immediately after each intervention and 30 minutes later within 24 hours postop
change in muscle tension from post-intervention to 30 minutes later by performing passive flexion and extension of patient's arm, and scoring 0 (relaxed), 1 (tense) or 2 (very tense/rigid)
Time frame: immediately after each intervention and 30 minutes later within 24 hours postop
change in anxiety from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
Time frame: immediately after each intervention and 30 minutes later within 24 hours postop
changes in 1-minute blood pressure average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor
Time frame: immediately after each intervention and 30 minutes later within 24 hours postop
changes in 1-minute heart rate average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor
Time frame: immediately after each intervention and 30 minutes later within 24 hours postop
changes in 1-minute respiratory rate average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor
Time frame: immediately after each intervention and 30 minutes later within 24 hours postop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Background: PubMed 23269131Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
- Background: PubMed 20347836Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.
- Background: PubMed 22964355Braun LA, Stanguts C, Casanelia L, Spitzer O, Paul E, Vardaxis NJ, Rosenfeldt F. Massage therapy for cardiac surgery patients--a randomized trial. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1453-9, 1459.e1. doi: 10.1016/j.jtcvs.2012.04.027. Epub 2012 Sep 7.
- Derived from this study: PubMed 27821384Boitor M, Martorella G, Laizner AM, Maheu C, Gelinas C. The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol. JMIR Res Protoc. 2016 Nov 7;5(4):e203. doi: 10.2196/resprot.6277.
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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.
Madalina Boitor, PhD(C) contact
Celine Gelinas, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hand massage, hand holding and application of unscented hypoallergenic cream in people with Pain, run by McGill University at 1 site in Canada.
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 3 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: status not confirmed, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madalina Boitor, PhD(C) (madalina.boitor@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale (time frame: before and immediately after each intervention within 24 hours postoperatively). 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 NCT02679534, which also lists 4 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 Apr 2016.