Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03187132
Collaborator
Travelers (Other), Samsung (Other), AppliedVR Inc. (Industry), Bayer (Industry), Hollywog, LLC (Other)
245
1
2
25.6
9.6

Study Details

Study Description

Brief Summary

This study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. Outpatients will be randomized to receive either the pain reduction kit or active control. The kit will contain a virtual reality (VR) headset, therapeutic VR visualization software, and a low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit. Clinical staff will monitor progress and provide scheduled coaching and outreach to patients in the intervention group. The control group will receive the low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit alone; they will not receive VR or remote coaching. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote clinical and technical support. Patients will be followed for 60 days and monitored for functional status, pain levels, use of pain medications (including opioids), satisfaction with care, and time to returning to work.

Condition or Disease Intervention/Treatment Phase
  • Device: Digital Pain Reduction Kit
  • Device: Active Control
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
245 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
Actual Study Start Date :
Apr 3, 2018
Actual Primary Completion Date :
May 20, 2020
Actual Study Completion Date :
May 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Digital Pain Reduction Kit

Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.

Device: Digital Pain Reduction Kit
A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.

Active Comparator: Active Control

Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.

Device: Active Control
An active control TENS unit used to reduce acute localized pain.

Outcome Measures

Primary Outcome Measures

  1. PROMIS - Physical Function Short Form 8b [60 days]

    PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.

Secondary Outcome Measures

  1. PROMIS - Pain Interference Short Form 8a [60 days]

    PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. A single Pain interference score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. By comparison, a Pain Interference T-score of 40 is one SD lower pain than average.

  2. Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) [60 days]

    The WPAI:LBP was created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Lower Back Pain. The WPAI:LBP productivity loss subscale consists of a single item ("During the past seven days, how much did your pain affect your productivity while you were working?") with a 0-10 response scale where 0 indicates pain had no effect, and 10 indicates pain completely prevented work. The presenteeism sub-scale consists of a comparison two items, yielding percent of hours missed due to pain. Finally, the activity impairment subscale consists of one item("During the past seven days, how much did your pain affect your ability to do your regular daily activities, other than work at a job?") with a 0-10 response scale where 0 indicated pain had no effect, and 10 indicated pain completely prevented daily activities.

  3. Patient Satisfaction Questionnaire (PSQ) 18 [60 days]

    Patient Satisfaction Questionnaire (PSQ) 18 which includes questions in 3 relevant domains: general satisfaction, communication, and accessibility of care. All subscales are scored so that high scores reflect satisfaction with medical care. Each domain averages responses to items with a range of 1-5, with 5 indicating the highest satisfaction.

  4. Binary, Self-reported Opioid Use [60 days]

    Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Provision of signed and dated informed consent form

  2. Stated willingness to comply with all study procedures and availability for the duration of the study

  3. Male or female, age 18 or older

  4. Seeking care for a musculoskeletal injury

  5. Experiencing pain greater than 3 out of 10 on a visual analog scale

  6. English or Spanish speaking

  7. Owns a compatible Android or iOS smartphone device (excluding tablets)

Exclusion Criteria:
  1. Unable to understand the goals of the study due to cognitive difficulty

  2. Use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for TENS units)

  3. Pregnant (contraindication for TENS unit)

  4. Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware or software

  5. Hypersensitivity to flashing light or motion

  6. Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of other study hardware (e.g., open sores, wounds, or skin rash on face)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars-Sinai Medical Center Los Angeles California United States 90048

Sponsors and Collaborators

  • Cedars-Sinai Medical Center
  • Travelers
  • Samsung
  • AppliedVR Inc.
  • Bayer
  • Hollywog, LLC

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Brennan Spiegel, Director, Health Services Research, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT03187132
Other Study ID Numbers:
  • Pro00049015
First Posted:
Jun 14, 2017
Last Update Posted:
Aug 5, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Brennan Spiegel, Director, Health Services Research, Cedars-Sinai Medical Center
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Initial Deployment: Inpatient trauma only, in-person recruitment of CSMC trauma patients with no opioid prescription. 3/28/2018 - 10/31/2018 Inpatient trauma + Pain Clinic. In-person recruitment of cLBP patients without opioid prescription at single CSMC pain specialty clinic. 11/1/2018 - 12/31/2018 Revised: Inpatient Trauma + Pain Clinic. Patients with opioid prescription allowed to participate. 1/1/2019 - 4/23/2019 Revised: Pain Clinic only, recruitment fully remote. 4/23/2019 - End
Pre-assignment Detail Of 1156 patients assessed for eligibility, 245 met criteria and were randomized.
Arm/Group Title Digital Pain Reduction Kit Active Control
Arm/Group Description Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain.
Period Title: Inpatient Trauma Only
STARTED 12 12
COMPLETED 8 0
NOT COMPLETED 4 12
Period Title: Inpatient Trauma Only
STARTED 4 5
COMPLETED 3 0
NOT COMPLETED 1 5
Period Title: Inpatient Trauma Only
STARTED 11 7
COMPLETED 8 0
NOT COMPLETED 3 7
Period Title: Inpatient Trauma Only
STARTED 76 118
COMPLETED 43 64
NOT COMPLETED 33 54

Baseline Characteristics

Arm/Group Title Digital Pain Reduction Kit Active Control Total
Arm/Group Description Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain. Total of all reporting groups
Overall Participants 67 69 136
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
64
95.5%
56
81.2%
120
88.2%
>=65 years
3
4.5%
13
18.8%
16
11.8%
Sex: Female, Male (Count of Participants)
Female
44
65.7%
48
69.6%
92
67.6%
Male
23
34.3%
21
30.4%
44
32.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
12
17.9%
9
13%
21
15.4%
Not Hispanic or Latino
55
82.1%
60
87%
115
84.6%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
6
9%
4
5.8%
10
7.4%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
15
22.4%
13
18.8%
28
20.6%
White
38
56.7%
46
66.7%
84
61.8%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
8
11.9%
6
8.7%
14
10.3%
PROMIS - Physical Function Short Form 8b (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
34.5
(6.5)
38.6
(6.3)
36.60
(6.69)

Outcome Measures

1. Primary Outcome
Title PROMIS - Physical Function Short Form 8b
Description PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Time Frame 60 days

Outcome Measure Data

Analysis Population Description
Participants with a week 1 response.
Arm/Group Title Digital Pain Reduction Kit Active Control
Arm/Group Description Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain.
Measure Participants 67 69
Mean (Standard Deviation) [units on a scale]
34.5
(6.5)
38.6
(6.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Digital Pain Reduction Kit, Active Control
Comments We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .111
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.86
Confidence Interval (2-Sided) 95%
-4.15 to .43
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.17
Estimation Comments The estimate is for the Digital Pain Reduction Kit arm.
2. Secondary Outcome
Title PROMIS - Pain Interference Short Form 8a
Description PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. A single Pain interference score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. By comparison, a Pain Interference T-score of 40 is one SD lower pain than average.
Time Frame 60 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Digital Pain Reduction Kit Active Control
Arm/Group Description Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain.
Measure Participants 64 69
Mean (Standard Deviation) [score on a scale]
64.8
(7.4)
63.2
(7.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Digital Pain Reduction Kit, Active Control
Comments We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .612
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .64
Confidence Interval (2-Sided) 95%
-1.84 to 3.12
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.27
Estimation Comments The estimate is for the Digital Pain Reduction Kit arm.
3. Secondary Outcome
Title Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0)
Description The WPAI:LBP was created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Lower Back Pain. The WPAI:LBP productivity loss subscale consists of a single item ("During the past seven days, how much did your pain affect your productivity while you were working?") with a 0-10 response scale where 0 indicates pain had no effect, and 10 indicates pain completely prevented work. The presenteeism sub-scale consists of a comparison two items, yielding percent of hours missed due to pain. Finally, the activity impairment subscale consists of one item("During the past seven days, how much did your pain affect your ability to do your regular daily activities, other than work at a job?") with a 0-10 response scale where 0 indicated pain had no effect, and 10 indicated pain completely prevented daily activities.
Time Frame 60 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Digital Pain Reduction Kit Active Control
Arm/Group Description Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain.
Measure Participants 39 46
WPAI: Presenteism (%hours)
26.9
(22.6)
26.4
(16.8)
WPAI: Productivity
7.3
(2.3)
7.1
(1.9)
WPAI: Activity Impairment
7.1
(2.8)
7.0
(2.5)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Digital Pain Reduction Kit, Active Control
Comments For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .87
Comments
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -.42
Confidence Interval (2-Sided) 95%
-5.51 to 4.66
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.58
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Digital Pain Reduction Kit, Active Control
Comments For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .787
Comments
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-.54 to .54
Parameter Dispersion Type: Standard Error of the Mean
Value: .274
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Digital Pain Reduction Kit, Active Control
Comments For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .569
Comments
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -.20
Confidence Interval (2-Sided) 95%
-.88 to .48
Parameter Dispersion Type: Standard Error of the Mean
Value: .34
Estimation Comments
4. Secondary Outcome
Title Patient Satisfaction Questionnaire (PSQ) 18
Description Patient Satisfaction Questionnaire (PSQ) 18 which includes questions in 3 relevant domains: general satisfaction, communication, and accessibility of care. All subscales are scored so that high scores reflect satisfaction with medical care. Each domain averages responses to items with a range of 1-5, with 5 indicating the highest satisfaction.
Time Frame 60 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Digital Pain Reduction Kit Active Control
Arm/Group Description Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain.
Measure Participants 50 65
PSQ General Satisfaction
3.25
(.15)
3.49
(.12)
PSQ Communication
3.55
(1.02)
3.84
(.80)
PSQ Access
3.2
(.85)
3.52
(.10)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Digital Pain Reduction Kit, Active Control
Comments For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .467
Comments
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .13
Confidence Interval (2-Sided) 95%
-.23 to .49
Parameter Dispersion Type: Standard Error of the Mean
Value: .090
Estimation Comments
5. Secondary Outcome
Title Binary, Self-reported Opioid Use
Description Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids).
Time Frame 60 days

Outcome Measure Data

Analysis Population Description
Includes all respondents to both primary outcome week 1 and opioid surveys.
Arm/Group Title Digital Pain Reduction Kit Active Control
Arm/Group Description Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain.
Measure Participants 53 66
Count of Participants [Participants]
11
16.4%
15
21.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Digital Pain Reduction Kit, Active Control
Comments We used a multilevel logistic regression with random effects at the individual level and fixed effects for week and study-arm.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .852
Comments
Method Regression, Logistic
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value .79
Confidence Interval (2-Sided) 95%
.07 to 9.07
Parameter Dispersion Type: Standard Error of the Mean
Value: .986
Estimation Comments

Adverse Events

Time Frame 10 weeks
Adverse Event Reporting Description
Arm/Group Title Digital Pain Reduction Kit Active Control
Arm/Group Description Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians. Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit. Active Control: An active control TENS unit used to reduce acute localized pain.
All Cause Mortality
Digital Pain Reduction Kit Active Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/103 (0%) 0/142 (0%)
Serious Adverse Events
Digital Pain Reduction Kit Active Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/103 (0%) 0/142 (0%)
Other (Not Including Serious) Adverse Events
Digital Pain Reduction Kit Active Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/103 (0%) 2/142 (1.4%)
Product Issues
Pain when using device 0/103 (0%) 0 1/142 (0.7%) 1
Random discharge & subsequent cramping 0/103 (0%) 0 1/142 (0.7%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title R. Brennan Spiegel
Organization CedarsSinaiMC
Phone 310-423-6784
Email Brennan.Spiegel@cshs.org
Responsible Party:
Brennan Spiegel, Director, Health Services Research, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT03187132
Other Study ID Numbers:
  • Pro00049015
First Posted:
Jun 14, 2017
Last Update Posted:
Aug 5, 2021
Last Verified:
Jul 1, 2021