Back PainNCT01355653
Heat Wrap Device Safety With Age and Body Fat
A study testing thermal therapy and ThermaCare heatwrap in people with Back Pain, run by Pfizer at 1 site in United States.
Trial summary
This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- thermal therapy and ThermaCare heatwrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2011to 28 Jul 2011
- 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 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2
- or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or < 30 kg/m2
- Females who are not pregnant or breastfeeding
- Subject is medically cleared for study participation
Who cannot join
- No sensitivitiy or allergy to device components in contact with skin
- Diabetes
- Any active skin disease or tattoos at the test site that would affect participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AN OPEN LABEL STUDY TO COMPARE THE EFFECTS OF AGE AND BODY FAT ON THE SAFETY OF TWO HEAT WRAP DEVICES IN HEALTHY SUBJECTS
This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.
Read the detailed description
Safety measurements
- Conditions
- Back Pain
- Being tested
- thermal therapy, ThermaCare heatwrap
- Keywords
- heat, device, safety, performance, heatwrap, elderly, overweight
- Medical subject headings
- Back Pain, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermal therapyDevice
heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day
ThermaCare heatwrapDevice
heatwrap, topical, one time application, 8 hour duration
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | thermal therapy Receives: Device: thermal therapy |
| Treatment B | Active comparator | ThermaCare Lower Back/Hip heatwrap Receives: Device: ThermaCare heatwrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with any thermal-related skin events (defined as elevated skin response, erythema ≥ 2.0 [moderate], or pain upon touch plus non-zero erythema)
Measured: morning after product wear through 15 days after last product application
Secondary outcomes (1)
Percentage of subjects with any adverse event
Measured: during and after wear for 28 days after last wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study start5 May 2011
- Primary completion28 Jul 2011
- Study completion28 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355653
- Sponsor's protocol ID
- B3571002
- Other IDs
- TC-09-12
- Status last verified
- Jun 2025
- First submitted
- 28 Apr 2011
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN LABEL STUDY TO COMPARE THE EFFECTS OF AGE AND BODY FAT ON THE SAFETY OF TWO HEAT WRAP DEVICES IN HEALTHY SUBJECTS
- ClinicalTrials.gov ID
- NCT01355653
- Acronym / sponsor ID
- B3571002
- Conditions
- Back Pain
- Keywords
- heat, device, safety, performance, heatwrap, elderly, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 May 2011 (actual)
- Primary completion
- 28 Jul 2011 (actual)
- Study completion
- 28 Jul 2011 (actual)
- First posted
- 18 May 2011 (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.
This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.
Detailed description
Safety measurements
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Device: thermal therapythermal therapy |
| Treatment B | Active comparator | Device: ThermaCare heatwrapThermaCare Lower Back/Hip heatwrap |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2
- or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or < 30 kg/m2
- Females who are not pregnant or breastfeeding
- Subject is medically cleared for study participation
Key exclusion criteria (3 listed)
- No sensitivitiy or allergy to device components in contact with skin
- Diabetes
- Any active skin disease or tattoos at the test site that would affect participation
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 |
|---|---|---|
| thermal therapyheat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day | Device | Treatment A |
| ThermaCare heatwrapheatwrap, topical, one time application, 8 hour duration | Device | Treatment B |
Primary outcome
Percentage of subjects with any thermal-related skin events (defined as elevated skin response, erythema ≥ 2.0 [moderate], or pain upon touch plus non-zero erythema)
Time frame: morning after product wear through 15 days after last product application
1 secondary outcome
Percentage of subjects with any adverse event
Time frame: during and after wear for 28 days after last wear
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 2 Jul 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thermal therapy and ThermaCare heatwrap in people with Back Pain, run by Pfizer 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 4 inclusion and 3 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 2 Jul 2025. 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?
Percentage of subjects with any thermal-related skin events (defined as elevated skin response, erythema ≥ 2.0 [moderate], or pain upon touch plus non-zero erythema) (time frame: morning after product wear through 15 days after last product application). 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 2 Jul 2025.