NCT02490943

A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in MS

A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in Multiple Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Brown, Theodore R., M.D., MPH · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Peginterferon-beta-1a (PEG) is an approved treatment for relapsing forms of MS that may cause injection related erythema. This is a randomized controlled cross-over trial of superficial hot and cold modalities to reduce injection site erythema caused by PEG.

Detailed description

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. Intervention: 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 Study Objectives: 1. To assess and compare the impact on erythema of two thermal treatments: warm compress prior to PEG injection and cold compress following PEG injection 2. To assess the natural history of PEG-erythema over time. This will be accomplished with 18 weeks of observation in the control group.

Conditions

• MS (Multiple Sclerosis)
• Erythema

Interventions

Type	Name	Description
OTHER	Warm Compress Before Injection	Receive warm compress before injection for three treatments, followed by cold compress after 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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-01-01
• Completion: 2019-04-30
• First posted: 2015-07-07
• Last updated: 2022-03-25

Locations

1 site across 1 country: United States