Low Level Laser Therapy for Chronic Constipation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing if a special light therapy can help people with severe constipation that doesn't improve with other treatments. The therapy involves multiple sessions over a few weeks. It aims to improve how nerves and muscles in the digestive system work together. Researchers will check if symptoms and quality of life improve after the treatment.
Will I have to stop taking my current medications?
If you are taking NSAIDs (non-steroidal anti-inflammatory drugs) or steroids, you will need to stop taking them to participate in this trial.
Is sacral neuromodulation safe for treating chronic constipation?
Sacral neuromodulation (SNM) is generally considered safe for treating conditions like fecal and urinary incontinence, with some adverse events such as electrode movement and infection reported. While evidence for its use in constipation is limited, it is promising for certain patients, and a testing phase can help predict treatment outcomes.12345
How is sacral neuromodulation different from other treatments for chronic constipation?
Sacral neuromodulation (SNM) is unique because it involves stimulating the sacral nerves, which can help regulate bowel function, and it is minimally invasive compared to other treatments. It has been used successfully in adults and is being explored for use in children, with ongoing research into optimizing its stimulation parameters for better outcomes.678910
What data supports the effectiveness of the treatment Sacral Neuromodulation for chronic constipation?
Research shows that sacral neuromodulation (a treatment that uses electrical impulses to stimulate nerves in the lower back) has been effective in treating constipation that doesn't respond to other treatments. Studies have found it to be a promising option for both adults and children with chronic constipation.5781112
Who Is on the Research Team?
Jihong Chen, MD PhD
Principal Investigator
McMaster University
Are You a Good Fit for This Trial?
This trial is for patients with severe chronic refractory constipation who have abnormal coordination between colonic motility and ano-rectal function, as shown by high resolution colonic manometry. It's not suitable for individuals with tattoos or light sensitivity in the treatment area, those taking NSAIDs or steroids, with malignancies or active bleeding in the treatment area, active deep vein thrombosis, or if pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive low level laser therapy for severe refractory chronic constipation
Follow-up
Participants are monitored for changes in symptoms, quality of life, and physiological assessments
What Are the Treatments Tested in This Trial?
Interventions
- Sacral Neuromodulation
Sacral Neuromodulation is already approved in United States, European Union, Canada for the following indications:
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Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor