Inflammatory Bowel Disease (IBD)NCT07681895
Biophysical Assessments of Acupuncture Points in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease (IBD), run by Brigham and Women's Hospital.
Trial summary
Acupuncture points or acupoints are fundamental to the practice of acupuncture, yet their scientific basis remains unclear. According to traditional explanations of acupuncture, acupoints can become tender or more sensitive to pressure when there is an underlying disease of the body. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 30 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with inflammatory bowel disease (IBD) and healthy control participants will be enrolled into the study from the Greater Boston area.
Who may be able to join
- adults (age 18 years or older)
- clinical diagnosis of ulcerative colitis or Crohn's disease
- adults (age 18 years or older) in good health conditions
Who cannot join
- any history of serious musculoskeletal or soft tissue injury of the lower and/or upper extremities
- presence of scarring or tattoo on the lower and/or upper extremities
- presence of serious cardiac diseases, severe dermatological conditions, peripheral neuropathy, infectious disease, psychological illnesses, or other serious co-morbidities (e.g., cancer)
- prior history of colostomy or ileostomy
- pregnancy
- history of chronic inflammatory diseases, such as IBD
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- severe digestive and/or intestinal conditions, such as irritable bowel syndrome (IBS)
- any history of serious musculoskeletal or soft tissue injury of the lower and/or upper extremities
- presence of scarring or tattoo on the lower and/or upper extremities
- presence of serious cardiac diseases, severe dermatological conditions, peripheral neuropathy, infectious disease, psychological illnesses, or other serious co-morbidities (e.g., cancer)
- pregnancy
About this study
Official title: Acupoint Sensitization in Inflammatory Bowel Disease: A Non-interventional Study
Acupuncture points or acupoints are fundamental to the practice of acupuncture, yet their scientific basis remains unclear. According to traditional explanations of acupuncture, acupoints can become tender or more sensitive to pressure when there is an underlying disease of the body. Findings from recent basic animal studies support this traditional theory. For example, compared to healthy control animals, models of colitis have shown increased skin temperature, blood flow, and pain sensitivity at specific body regions that correspond to the location of acupoints that are commonly used in acupuncture treatment for colitis. However, little is known about whether these findings apply to humans.
Read the detailed description
Acupuncture is broadly understood as a technique in which practitioners stimulate specific points on the body - most often by inserting thin needles through the skin. Accordingly, acupuncture is theorized to "work" or provide therapeutic benefits through stimulation of specific points, collectively referred to as acupoints. However, to date, there is no clear scientific characterization of acupoints based on an objective, biomedical understanding of the body, which limits our understanding of how acupuncture works in a fundamental way.
Recent findings from basic animal studies suggest that cutaneous neurogenic inflammation may be a potential physiological correlate of acupoints, in the context of visceral diseases. Neurogenic inflammation refers to the role of sensory nerves in promoting inflammation and is mediated by neuropeptides released from the peripheral afferent terminals. Through interactions with nearby immune cells and endothelial cells, these neuropeptides promote increased levels of inflammatory mediators and induce vasodilation and plasma extravasation at the site of their release. In basic animal studies, Evans blue (EB) dye is typically used as a marker for microvascular leakage to assess the location and extent of neurogenic inflammation.
Using EB dye, several studies have provided compelling evidence that experimentally induced visceral diseases (e.g., rodent models of colitis, cystitis, gastritis) cause cutaneous neurogenic inflammation. In many of these studies, neurogenic inflammation was shown to manifest as discrete spots on certain body regions, corresponding to the locations of specific acupoints.
To date, little to no studies have been done to validate the aforementioned preclinical findings in human subjects. To bridge this gap, in this study, we will conduct clinical and translational (C/T) research in human subjects, using inflammatory bowel disease (IBD) as the disease model. We will compare measures of cutaneous sensitization in IBD patients and healthy control participants. Key features of neurogenic inflammation include increased blood flow, increased temperature, and pain sensitivity, so we will assess cutaneous blood perfusion, temperature, and pressure pain threshold (PPT) as proxy measures, using laser speckle contrast imaging (LSCI), infrared thermography, and pressure algometry, respectively.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- Inflammatory bowel disease, IBD, Acupuncture point, Acupoint, Cutaneous neurogenic inflammation, Infrared thermography, Laser speckle contrast imaging, Pressure pain threshold
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBD | Adults with inflammatory bowel disease (IBD). This is a non-interventional study, involving noninvasive biophysical assessments of the skin in adults with IBD vs. healthy control participants. | |
| Control | Healthy control participants. This is a non-interventional study, involving noninvasive biophysical assessments of the skin in adults with IBD vs. healthy control participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin blood perfusion
Comparisons of cutaneous blood perfusion at predefined regions or points of interest between IBD patients and healthy control participants, as measured by laser speckle contrast imaging (LSCI). LSCI is a non-invasive imaging technique for assessing superficial tissue blood perfusion.
Measured: 1 day
Skin temperature
Comparisons of skin temperature at predefined regions or points of interest between IBD patients and healthy control participants, as measured by infrared thermography.
Measured: 1 day
Pressure pain threshold
Comparisons of pressure pain threshold (PPT) at predefined points of interest between IBD patients and healthy control participants, as measured by pressure algometry.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, EunMee Yang, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681895
- Sponsor's protocol ID
- 2025P002489
- Other IDs
- 1K23AT013401-01
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupoint Sensitization in Inflammatory Bowel Disease: A Non-interventional Study
- ClinicalTrials.gov ID
- NCT07681895
- Acronym / sponsor ID
- 2025P002489
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- Inflammatory bowel disease, IBD, Acupuncture point, Acupoint, Cutaneous neurogenic inflammation, Infrared thermography, Laser speckle contrast imaging, Pressure pain threshold
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 2 Jul 2026 (actual)
- 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.
Acupuncture points or acupoints are fundamental to the practice of acupuncture, yet their scientific basis remains unclear. According to traditional explanations of acupuncture, acupoints can become tender or more sensitive to pressure when there is an underlying disease of the body. Findings from recent basic animal studies support this traditional theory. For example, compared to healthy control animals, models of colitis have shown increased skin temperature, blood flow, and pain sensitivity at specific body regions that correspond to the location of acupoints that are commonly used in acupuncture treatment for colitis. However, little is known about whether these findings apply to humans.
Detailed description
Acupuncture is broadly understood as a technique in which practitioners stimulate specific points on the body - most often by inserting thin needles through the skin. Accordingly, acupuncture is theorized to "work" or provide therapeutic benefits through stimulation of specific points, collectively referred to as acupoints. However, to date, there is no clear scientific characterization of acupoints based on an objective, biomedical understanding of the body, which limits our understanding of how acupuncture works in a fundamental way.
Recent findings from basic animal studies suggest that cutaneous neurogenic inflammation may be a potential physiological correlate of acupoints, in the context of visceral diseases. Neurogenic inflammation refers to the role of sensory nerves in promoting inflammation and is mediated by neuropeptides released from the peripheral afferent terminals. Through interactions with nearby immune cells and endothelial cells, these neuropeptides promote increased levels of inflammatory mediators and induce vasodilation and plasma extravasation at the site of their release. In basic animal studies, Evans blue (EB) dye is typically used as a marker for microvascular leakage to assess the location and extent of neurogenic inflammation.
Using EB dye, several studies have provided compelling evidence that experimentally induced visceral diseases (e.g., rodent models of colitis, cystitis, gastritis) cause cutaneous neurogenic inflammation. In many of these studies, neurogenic inflammation was shown to manifest as discrete spots on certain body regions, corresponding to the locations of specific acupoints.
To date, little to no studies have been done to validate the aforementioned preclinical findings in human subjects. To bridge this gap, in this study, we will conduct clinical and translational (C/T) research in human subjects, using inflammatory bowel disease (IBD) as the disease model. We will compare measures of cutaneous sensitization in IBD patients and healthy control participants. Key features of neurogenic inflammation include increased blood flow, increased temperature, and pain sensitivity, so we will assess cutaneous blood perfusion, temperature, and pressure pain threshold (PPT) as proxy measures, using laser speckle contrast imaging (LSCI), infrared thermography, and pressure algometry, respectively.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD | – | –Adults with inflammatory bowel disease (IBD). This is a non-interventional study, involving noninvasive biophysical assessments of the skin in adults with IBD vs. healthy control participants. |
| Control | – | –Healthy control participants. This is a non-interventional study, involving noninvasive biophysical assessments of the skin in adults with IBD vs. healthy control participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with inflammatory bowel disease (IBD) and healthy control participants will be enrolled into the study from the Greater Boston area.
Key inclusion criteria (3 listed)
- adults (age 18 years or older)
- clinical diagnosis of ulcerative colitis or Crohn's disease
- adults (age 18 years or older) in good health conditions
Key exclusion criteria (11 listed)
- any history of serious musculoskeletal or soft tissue injury of the lower and/or upper extremities
- presence of scarring or tattoo on the lower and/or upper extremities
- presence of serious cardiac diseases, severe dermatological conditions, peripheral neuropathy, infectious disease, psychological illnesses, or other serious co-morbidities (e.g., cancer)
- prior history of colostomy or ileostomy
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin blood perfusion
Time frame: 1 day
Comparisons of cutaneous blood perfusion at predefined regions or points of interest between IBD patients and healthy control participants, as measured by laser speckle contrast imaging (LSCI). LSCI is a non-invasive imaging technique for assessing superficial tissue blood perfusion.
Skin temperature
Time frame: 1 day
Comparisons of skin temperature at predefined regions or points of interest between IBD patients and healthy control participants, as measured by infrared thermography.
Pressure pain threshold
Time frame: 1 day
Comparisons of pressure pain threshold (PPT) at predefined points of interest between IBD patients and healthy control participants, as measured by pressure algometry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD), run by Brigham and Women's Hospital.
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 11 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Skin blood perfusion (time frame: 1 day). The study lists 3 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 20 Oct 2026.