Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study
NCT06109961
Crohn Disease, Digestive System Diseases
View Trial DetailsNCT Number: NCT07681895
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Adults with IBD):
Exclusion criteria
(Adults with IBD):
Inclusion criteria
(Healthy control participants):
Exclusion criteria
(Healthy control participants):
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.
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.
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.
Brigham and Women's Hospital
Other
Acupoint Sensitization in Inflammatory Bowel Disease: A Non-interventional Study
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