MS (Multiple Sclerosis)PEG-ThermalNCT02490943
A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in MS
A study testing Warm Compress Before Injection and Cold Compress After Injection in people with MS (Multiple Sclerosis) and Erythema, run by Brown, Theodore R., M.D., MPH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MS (Multiple Sclerosis), Erythema
- What is being tested?
- Warm Compress Before Injection and Cold Compress After Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in Multiple Sclerosis
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.
Read the 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:
- 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.
- Conditions
- MS (Multiple Sclerosis), Erythema
- Being tested
- Warm Compress Before Injection, Cold Compress After Injection
- Keywords
- peginterferon beta-1a, MS (Multiple Sclerosis), Injection Site Reaction Erythema
- Medical subject headings
- Multiple Sclerosis, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Compress Before InjectionOther
Also called Group A
Receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.
Cold Compress After InjectionOther
Also called Group B
Receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.
| Study group | Role | What they receive |
|---|---|---|
| Warm Compress Pre-Injection | Active comparator | Group A, N = 10, will receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments. Receives: Other: Warm Compress Before Injection |
| Cold Compress Post-Injection | Active comparator | Group B, N= 10, will receive cold compress after injection for three treatments followed by warm compress before injection for three treatments. Receives: Other: Cold Compress After Injection |
| No Intervention Pre/Post-Injection | No intervention | Group C, N= 8, will receive no treatment for six injections following screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline ISR Erythema Index at 24 hours, 7 days, and 14 days every 6 weeks for 18 weeks.
Participants will record the diameter of patch of skin discoloration in millimeters, measuring at the maximum width.
Measured: 24 hours, 7 days, 14 days
Secondary outcomes (5)
Change from baseline in rating of Modified Local Injection Site Reaction Scale
Measured: 24 hours
Erythema score on the Visual Assessment Scale.
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
Measured: Change from Baseline in VAS at 24 hours, 7 days, and 14 days.
Pain score on the visual analogue scale after 10-minutes.
(post-injection, 0-10 visual analogue scale (VAS))
Measured: 10 min.
Pain score on the visual analogue scale Post-Injection 24 hours, 7 days, and 14 days
(post-injection, 0-10 visual analogue scale (VAS))
Measured: Change from Baseline in VAS at 24 hours, 7 days, and 14 days.
Level of Comfort Post-Injection Impression of Last 3 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.
Measured: 18 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startJun 2015
- Primary completion1 Jan 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MS (Multiple Sclerosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Collaborators
- Evergreen Healthcare
- Responsible party
- Sponsor
- Investigators
- Theodore R Brown, M.D., MPH, Principal investigator, Evergreen Health Nueroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490943
- Sponsor's protocol ID
- TRB2015
- Acronym
- PEG-Thermal
- Status last verified
- Jan 2019
- First submitted
- 24 Jun 2015
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02490943
- Acronym / sponsor ID
- PEG-Thermal / TRB2015
- Conditions
- MS (Multiple Sclerosis), Erythema
- Keywords
- peginterferon beta-1a, MS (Multiple Sclerosis), Injection Site Reaction Erythema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Collaborators
- Evergreen Healthcare
- Study start
- Jun 2015
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Warm Compress Pre-Injection | Active comparator | Other: Warm Compress Before InjectionGroup A, N = 10, will receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments. |
| Cold Compress Post-Injection | Active comparator | Other: Cold Compress After InjectionGroup B, N= 10, will receive cold compress after injection for three treatments followed by warm compress before injection for three treatments. |
| No Intervention Pre/Post-Injection | No intervention | –Group C, N= 8, will receive no treatment for six injections following screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Any contraindication to warm or cold compress:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm Compress Before InjectionAlso: Group AReceive warm compress before injection for three treatments, followed by cold compress after injection for three treatments. | Other | Warm Compress Pre-Injection |
| Cold Compress After InjectionAlso: Group BReceive cold compress after injection for three treatments followed by warm compress before injection for three treatments. | Other | Cold Compress Post-Injection |
Primary outcome
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.
5 secondary outcomes
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.
Pain score on the visual analogue scale after 10-minutes.
Time frame: 10 min.
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.
Level of Comfort Post-Injection Impression of Last 3 Weeks.
Time frame: 18 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore R Brown, M.D., MPH principal investigator
Evergreen Health Nueroscience Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Compress Before Injection and Cold Compress After Injection in people with MS (Multiple Sclerosis) and Erythema, run by Brown, Theodore R., M.D., MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.