A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer
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|ClinicalTrials.gov Identifier: NCT03707444|
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer Pancreas Pain Syndrome Cancer Related Pain||Device: Scrambler Therapy Device||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm study of 20 patients|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
Experimental: Scrambler Therapy
All participants get the same device treatment with the Scrambler Therapy device, up to 10 treatments.
Device: Scrambler Therapy Device
Superficial neuromodulation using EKG type electrodes [Scrambler (MC5-A Calmare) Therapy]
- Change in Average pain as assessed by Brief Pain Inventory Question 3 [ Time Frame: Day 0, Day 28 ]Change in average pain will be evaluated using the Brief Pain Inventory Question 3. This is scored from 0 to 10 with 0 being no pain and 10 being worst pain.
- Change in Pain as assessed by Brief Pain Inventory [ Time Frame: Day 0, Day 28 ]The change in pain will be assessed by the standard Brief Pain Inventory which has 35 items with an overall scoring of 0 to 10. A score of 0 means no pain and a score of 10 means worst pain.
- Change in opioid use [ Time Frame: Day 0, Day 28 ]The amount of opioids in milligrams used between day 0 and day 28 will be converted to morphine equivalents to assess any change in the amount of opioid used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707444
|Contact: Thomas J Smith, MDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Thomas J Smith, MD 410-955-2091 email@example.com|
|Principal Investigator:||Thomas J Smith, MD||Johns Hopkins Sidney Kimmel COmprehensive Cancer Center|