Sacral Neuromodulation as Treatment for Chronic Constipation
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Treatments
Details and patient eligibility
About
The objective of this study is to study if low level laser therapy will do more good than harm for patients with severe chronic refractory constipation. It is a proof of concept study without a placebo arm.
Full description
Patients will be offered the therapy if High-Resolution Colonic Manometry has shown that coordination between colon motility and recto-anal activity is abnormal and that autonomic nervous system assessment suggests a dysfunction of communication between the spinal cord autonomic nerves and the colon-rectum-anus. The therapy consists of a 3 week treatment with a total of 8 sessions of low level laser therapy. Effects will be assessed using symptom and quality of life questionnaires and physiological assessments of colon and pelvic floor function, at 4 weeks and 12 weeks.
Enrollment
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Ages
Volunteers
Inclusion criteria
- Patients with severe chronic refractory constipation
- Must have undergone high resolution colonic manometry that shows abnormal coordination between colonic motility and ano-rectal function.
Exclusion criteria
- Pregnant patients
- Known malignancies in the area of treatment
- Active bleeding in area of treatment
- Active deep vein thrombosis
- When tatoos are present at area of treatment
- Patients that are light sensitive
- Patients who take NSAIDS or steroids.
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Jan D Huizinga, PhD; Jihong Chen, MD PhD
Data sourced from clinicaltrials.gov
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