A Pilot Study of Warm and Cold Compress to Reduce Injection Site Eryth
A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Warm Compress Before Injection
- Cold Compress After Injection
What it measured
Main measures
Change from Baseline ISR Erythema Index at 24 hours, 7 days, and 14 days every 6 weeks for 18 weeks.
24 hours, 7 days, 14 days
Other measures (5)
Change from baseline in rating of Modified Local Injection Site Reaction Scale
24 hours
SafetyErythema score on the Visual Assessment Scale.
Change from Baseline in VAS at 24 hours, 7 days, and 14 days.
Pain score on the visual analogue scale after 10-minutes.
10 min.
PainPain score on the visual analogue scale Post-Injection 24 hours, 7 days, and 14 days
Change from Baseline in VAS at 24 hours, 7 days, and 14 days.
PainLevel of Comfort Post-Injection Impression of Last 3 Weeks.
18 Weeks
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Diagnosis of MS made at least 3 months prior based on McDonald criteria. * Age 18 or more * Ongoing treatment with PEG for 30 days or more at screening * No MS exacerbation for 60 days prior to screening. * Score of ≥50 on screening ISR Erythema Index * Home access to microwave oven and freezer * Written informed consent
Exclusion criteria
* Any contraindication to warm or cold compress: * Inability to sense temperature change by patient report * Metal implant near injection site (e.g. injection near intra-abdominal baclofen pump) * History of allergy or intolerance to local heat or cold application * Bleeding disorder * Concomitant use of any topical prescription medication at injection site * Females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures) * Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing. * Any other serious and/or unstable medical condition
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Loading reviews and guidelines…
History
Started
Jun 2015
Main results due
Jan 2019
Finished
Apr 2019