A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in MS (PEG-Thermal)
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|ClinicalTrials.gov Identifier: NCT02490943|
Recruitment Status : Completed
First Posted : July 7, 2015
Last Update Posted : March 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|MS (Multiple Sclerosis) Erythema||Other: Warm Compress Before Injection Other: Cold Compress After Injection||Not Applicable|
The most common adverse event associated with this subcutaneously (SC) injected drug is injection site reaction (ISR) including redness and pain.Theoretically, both heat and cold modalities may improve interferon injection tolerance. Warm compress before injection may increase local blood flow and increase rapid systemic absorption, while cold compress afterward may reduce the erythema, edema and pain that often follow SC injections. A trial comparing heat-before and cold-after therapy is warranted to determine the relative effectiveness of these modalities.
Product: Reusable cold and warm compress.
Patients will receive written instructions for microwave heating and freezer cooling of the compress.
Warm compress: Pre-heating in microwave oven, per instructions. Apply warm compress for 5 minutes prior to injection. The initial compress temperature will be about 43 degrees Celsius (range 40-46 degrees Celsius) and slowly decline during application. Administer drug soon after removal.
Cold compress: Cooling in a freezer as per instructions. Soon after drug injection, apply cold compress for 10 minutes. The initial compress temperature will range 15-18 degrees Celsius.
- Timers will be utilized to mark 5-minute and 10-minute treatment intervals
- Participants will be encouraged to maintain constant practices with regards to non-steroidal anti-inflammatory drug use during the study
- To assess and compare the impact on erythema of two thermal treatments: warm compress prior to PEG injection and cold compress following PEG injection
- To assess the natural history of PEG-erythema over time. This will be accomplished with 18 weeks of observation in the control group.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Participants were randomized to warm compress (WC) for three injections, followed by cold compress (CC) for three injections, CC followed by WC, each for three injections or no treatment for six injections|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in Multiple Sclerosis|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||January 1, 2019|
|Actual Study Completion Date :||April 30, 2019|
Active Comparator: Warm Compress Pre-Injection
Group A, N = 10, will receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.
Other: Warm Compress Before Injection
Receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.
Other Name: Group A
Active Comparator: Cold Compress Post-Injection
Group B, N= 10, will receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.
Other: Cold Compress After Injection
Receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.
Other Name: Group B
No Intervention: No Intervention Pre/Post-Injection
Group C, N= 8, will receive no treatment for six injections following screening.
- Change from Baseline ISR Erythema Index at 24 hours, 7 days, and 14 days every 6 weeks for 18 weeks. [ Time Frame: 24 hours, 7 days, 14 days ]Participants will record the diameter of patch of skin discoloration in millimeters, measuring at the maximum width.
- Change from baseline in rating of Modified Local Injection Site Reaction Scale [ Time Frame: 24 hours ]
- Erythema score on the Visual Assessment Scale. [ Time Frame: Change from Baseline in VAS at 24 hours, 7 days, and 14 days. ]This is a 5 point visual assessment scale. Participants will be asked to observe the change in skin color at the site of injection. They will rate the intensity of skin color change (erythema) using the scale below. These assessments will be recorded at the following time points: 24 hours, 7 days, and 14 days
- Pain score on the visual analogue scale after 10-minutes. [ Time Frame: 10 min. ](post-injection, 0-10 visual analogue scale (VAS))
- Pain score on the visual analogue scale Post-Injection 24 hours, 7 days, and 14 days [ Time Frame: Change from Baseline in VAS at 24 hours, 7 days, and 14 days. ](post-injection, 0-10 visual analogue scale (VAS))
- Level of Comfort Post-Injection Impression of Last 3 Weeks. [ Time Frame: 18 Weeks ]This is a single question: "How would you rate your level of comfort with the last three injections?" This is on a 0-10 VAS with 0= "extremely bad" 5="neither good nor bad" and 10= "extremely good." The question will be answered at the end of each phase of the study.
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): NCT02490943
|United States, Washington|
|Kirkland, Washington, United States, 98034|
|Principal Investigator:||Theodore R Brown, M.D., MPH||Evergreen Health Nueroscience Institute|