Chronic PainNCT05399771
Radiofrequency Hyperthermia Safety Study
A study testing Laser Doppler, Radiofrequency Heating System and Thermal Imaging in people with Chronic Pain and Soft Tissue Injuries, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study will include 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria. Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Soft Tissue Injuries, Wound Heal
- What is being tested?
- Laser Doppler, Radiofrequency Heating System and Thermal Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2022to 23 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Healthy
- 20<BMI<40
Who cannot join
- Pregnant, nursing or child bearing potential
- Active infections of the skin in the lower leg
- Open or healing wounds on the lower leg
- Autoimmune disorder
- 40<BMI <20
- History of blood clots
- History of lower limb edema
- Tattoos and metal hardware in the leg
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Radiofrequency Hyperthermia Safety Study (RHySS)
This study will include 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria. Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. Subjects will receive weekly treatments for 4 weeks, and will be re-evaluated 4 weeks after the last treatment to assess any tissue changes that continue after the treatments have concluded.
Read the detailed description
This study will include 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria below. Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. The pad will be applied to the back of the leg and will covered using a compression stocking. The other leg will receive a pad and compression stocking, but radiofrequency will not be applied (no heating).
At the first visit, subjects will be asked to fill out a healthcare questionnaire. With each weekly treatment, subjects will be evaluated to assess how their legs feel on a scale of 1-10, with 1 being no discomfort and 10 being intense pain. Their legs will be photographed before and after radiofrequency MH to examine any visible changes to the tissue. Study team will then use a PeriScan PIM 3 System Laser Doppler scanning for blood perfusion before the Thermofield treatment. The radiofrequency will be set to achieve 40°C/107.6°F) and maintain this temperature consistently during the application time. This temperature is mild and may feel like a drugstore heating pad. The device will be turned on on one leg and will remain off on the other. The time for the heating will be 36 minutes, during which participants will remain in a reclined position, with their legs elevated. The device takes approximately 6 minutes to achieve a tissue temperature of 40°C, and the treatment time with consistent temperature application will be 30 minutes. Study team will then use a PeriScan PIM 3 System Laser Doppler scanning for blood perfusion after the Thermofield treatment ends. Study team will take thermal imaging photographs of the treatment area following each treatment.
Subjects will receive weekly treatments for 4 weeks, and will be re-evaluated 4 weeks after the last treatment to assess any tissue changes that continue after the treatments have concluded. Subjects will be excluded from the study if they develop any kind of intolerance to the MH treatment, like increased pain or unexpected skin changes. If they receive a significant injury or wound that is not due to the study, such that the skin of the lower leg is no longer intact, they will be excluded from the study.
- Conditions
- Chronic Pain, Soft Tissue Injuries, Wound Heal, Blood Flow
- Being tested
- Laser Doppler, Radiofrequency Heating System, Thermal Imaging, Healthcare Questionnaire & Measurement
- Keywords
- mild hyperthermia
- Medical subject headings
- Chronic Pain, Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser DopplerDevice
Also called PeriScan PIM 3 System Laser Doppler
Study team will use a PeriScan PIM 3 System Laser Doppler to scan for blood perfusion before and after the Thermofield treatment. The PeriScan PIM 3 System is for non-invasive two-dimensional imaging of peripheral tissue.
Radiofrequency Heating SystemDevice
Also called Thermofield
The radiofrequency will be set to achieve 42°C/107.6°F) and maintain this temperature consistently during the application time. This temperature is mild and may feel like a drugstore heating pad. The device will be turned on on one leg and will remain off on the other. The time for the heating will be 36 minutes, during which participants will remain in a reclined position, with their legs elevated. The device takes approximately 6 minutes to achieve a tissue temperature of 42°C, and the treatment time with consistent temperature application will be 30 minutes.
Thermal ImagingDevice
Study team will take thermal imaging photographs of the treatment area following each treatment.
Healthcare Questionnaire & MeasurementOther
A survey tool created to collect info from participants including:
- Name
- Age
- Weight/ height
- Pregnant or nursing?
- History of blood clots?
- Any wound healing problems?
- Any active open wounds on the legs?
- Any autoimmune disorders?
- Phone number
- Email address
A measurement of the participants calf will be taken as well using a measuring tape.
| Study group | Role | What they receive |
|---|---|---|
| Thermofield temperature controlled radiofrequency device | Experimental | Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. The pad will be applied to the back of the leg and will covered using a compression stocking. The other leg will receive a pad and compression stocking, but radiofrequency will not be applied (no heating). Receives: Device: Laser Doppler; Device: Radiofrequency Heating System; Device: Thermal Imaging; Other: Healthcare Questionnaire & Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Temperature Change- Skin Evaluation on Leg With Device
To help determine safety during and after dermal application for generating elevated temperatures
Measured: week 1
Mean Temperature Change- Skin Evaluation on Leg With Device
To help determine safety during and after dermal application for generating elevated temperatures
Measured: week 2
Mean Temperature Change- Skin Evaluation on Leg With Device
To help determine safety during and after dermal application for generating elevated temperatures
Measured: week 3
Mean Temperature Change- Skin Evaluation on Leg With Device
To help determine safety during and after dermal application for generating elevated temperatures
Measured: week 4
Mean Change in Blood Perfusion Assessment - mL/kg/Min
Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied.
Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)
Measured: week 1
Blood Perfusion Assessment - mL/kg/Min
Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied.
Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)
Measured: week 2
Blood Perfusion Assessment - mL/kg/Min
Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied.
Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)
Measured: week 3
Blood Perfusion Assessment - mL/kg/Min
Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied.
Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)
Measured: week 4
Blood Perfusion Assessment - mL/kg/Min
Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied.
Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)
Measured: week 8
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.
Measured: week 1
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.
Measured: week 2
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.
Measured: week 3
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.
Measured: week 4
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.
Measured: week 8
Safety: Number of Blister Formations
Cumulative number of blisters formed across all participants during weekly sessions from week 1 to 8 is reported in the data table.
Measured: From week 1 through week 8
Safety: Significant Changes in Redness
Number of participants with significant changes in redness that required intervention.
Measured: from week 1 through week 8
Secondary outcomes (4)
Number of Participants Who Attended the Session
The number of participants who attend hyperthermia sessions will be documented.
Measured: week 1
Number of Participants Who Attended the Session
The number of participants who attend hyperthermia sessions will be documented.
Measured: week 2
Number of Participants Who Attended the Session
The number of participants who attend hyperthermia sessions will be documented.
Measured: week 3
Number of Participants Who Attended the Session
The number of participants who attend hyperthermia sessions will be documented.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start27 Jun 2022
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria - Participants will serve as their own control, by heating one leg and no the other.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- thermofield
- Responsible party
- Sponsor
- Investigators
- Nicole Levi, PhD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399771
- Sponsor's protocol ID
- IRB00075221
- Status last verified
- May 2024
- First submitted
- 18 May 2022
- Last updated
- 3 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Hyperthermia Safety Study (RHySS)
- ClinicalTrials.gov ID
- NCT05399771
- Acronym / sponsor ID
- IRB00075221
- Conditions
- Chronic Pain, Soft Tissue Injuries, Wound Heal, Blood Flow
- Keywords
- mild hyperthermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- thermofield
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Posted 3 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will include 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria. Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. Subjects will receive weekly treatments for 4 weeks, and will be re-evaluated 4 weeks after the last treatment to assess any tissue changes that continue after the treatments have concluded.
Detailed description
This study will include 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria below. Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. The pad will be applied to the back of the leg and will covered using a compression stocking. The other leg will receive a pad and compression stocking, but radiofrequency will not be applied (no heating).
At the first visit, subjects will be asked to fill out a healthcare questionnaire. With each weekly treatment, subjects will be evaluated to assess how their legs feel on a scale of 1-10, with 1 being no discomfort and 10 being intense pain. Their legs will be photographed before and after radiofrequency MH to examine any visible changes to the tissue. Study team will then use a PeriScan PIM 3 System Laser Doppler scanning for blood perfusion before the Thermofield treatment. The radiofrequency will be set to achieve 40°C/107.6°F) and maintain this temperature consistently during the application time. This temperature is mild and may feel like a drugstore heating pad. The device will be turned on on one leg and will remain off on the other. The time for the heating will be 36 minutes, during which participants will remain in a reclined position, with their legs elevated. The device takes approximately 6 minutes to achieve a tissue temperature of 40°C, and the treatment time with consistent temperature application will be 30 minutes. Study team will then use a PeriScan PIM 3 System Laser Doppler scanning for blood perfusion after the Thermofield treatment ends. Study team will take thermal imaging photographs of the treatment area following each treatment.
Subjects will receive weekly treatments for 4 weeks, and will be re-evaluated 4 weeks after the last treatment to assess any tissue changes that continue after the treatments have concluded. Subjects will be excluded from the study if they develop any kind of intolerance to the MH treatment, like increased pain or unexpected skin changes. If they receive a significant injury or wound that is not due to the study, such that the skin of the lower leg is no longer intact, they will be excluded from the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria - Participants will serve as their own control, by heating one leg and no the other.
| Arm | Type | Receives |
|---|---|---|
| Thermofield temperature controlled radiofrequency device | Experimental | Device: Laser Doppler, Device: Radiofrequency Heating System, Device: Thermal Imaging, Other: Healthcare Questionnaire & MeasurementParticipants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. The pad will be applied to the back of the leg and will covered using a compression stocking. The other leg will receive a pad and compression stocking, but radiofrequency will not be applied (no heating). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Healthy
- 20<BMI<40
Key exclusion criteria (8 listed)
- Pregnant, nursing or child bearing potential
- Active infections of the skin in the lower leg
- Open or healing wounds on the lower leg
- Autoimmune disorder
- 40<BMI <20
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 |
|---|---|---|
| Laser DopplerAlso: PeriScan PIM 3 System Laser DopplerStudy team will use a PeriScan PIM 3 System Laser Doppler to scan for blood perfusion before and after the Thermofield treatment. The PeriScan PIM 3 System is for non-invasive two-dimensional imaging of peripheral tissue. | Device | Thermofield temperature controlled radiofrequency device |
| Radiofrequency Heating SystemAlso: ThermofieldThe radiofrequency will be set to achieve 42°C/107.6°F) and maintain this temperature consistently during the application time. This temperature is mild and may feel like a drugstore heating pad. The device will be turned on on one leg and will remain off on the other. The time for the heating will be 36 minutes, during which participants will remain in a reclined position, with their legs elevated. The device takes approximately 6 minutes to achieve a tissue temperature of 42°C, and the treatment time with consistent temperature application will be 30 minutes. | Device | Thermofield temperature controlled radiofrequency device |
| Thermal ImagingStudy team will take thermal imaging photographs of the treatment area following each treatment. | Device | Thermofield temperature controlled radiofrequency device |
| Healthcare Questionnaire & MeasurementA survey tool created to collect info from participants including: 1. Name 2. Age 3. Weight/ height 4. Pregnant or nursing? 5. History of blood clots? 6. Any wound healing problems? 7. Any active open wounds on the legs? 8. Any autoimmune disorders? 9. Phone number 10. Email address A measurement of the participants calf will be taken as well using a measuring tape. | Other | Thermofield temperature controlled radiofrequency device |
Primary outcome
Mean Temperature Change- Skin Evaluation on Leg With Device
Time frame: week 1
To help determine safety during and after dermal application for generating elevated temperatures
Mean Temperature Change- Skin Evaluation on Leg With Device
Time frame: week 2
To help determine safety during and after dermal application for generating elevated temperatures
Mean Temperature Change- Skin Evaluation on Leg With Device
Time frame: week 3
To help determine safety during and after dermal application for generating elevated temperatures
Mean Temperature Change- Skin Evaluation on Leg With Device
Time frame: week 4
To help determine safety during and after dermal application for generating elevated temperatures
Mean Change in Blood Perfusion Assessment - mL/kg/Min
Time frame: week 1
Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)
Blood Perfusion Assessment - mL/kg/Min
Time frame: week 2
Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)
Blood Perfusion Assessment - mL/kg/Min
Time frame: week 3
Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)
Blood Perfusion Assessment - mL/kg/Min
Time frame: week 4
Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)
Blood Perfusion Assessment - mL/kg/Min
Time frame: week 8
Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
Time frame: week 1
A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
Time frame: week 2
A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
Time frame: week 3
A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
Time frame: week 4
A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.
Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment
Time frame: week 8
A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.
Safety: Number of Blister Formations
Time frame: From week 1 through week 8
Cumulative number of blisters formed across all participants during weekly sessions from week 1 to 8 is reported in the data table.
Safety: Significant Changes in Redness
Time frame: from week 1 through week 8
Number of participants with significant changes in redness that required intervention.
4 secondary outcomes
Number of Participants Who Attended the Session
Time frame: week 1
Number of Participants Who Attended the Session
Time frame: week 2
Number of Participants Who Attended the Session
Time frame: week 3
Number of Participants Who Attended the Session
Time frame: week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Nicole Levi, PhD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Doppler, Radiofrequency Heating System and Thermal Imaging in people with Chronic Pain and Soft Tissue Injuries, run by Wake Forest University Health Sciences 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 3 inclusion and 8 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 3 May 2024. 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?
Yes. Results are posted in the registry (first posted 3 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Temperature Change- Skin Evaluation on Leg With Device (time frame: week 1). The study lists 16 primary outcomes in all. 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 3 May 2024; AzTrials last refreshed its copy on 27 Oct 2026.