Using low level laser therapy to treat chronic constipation
Sacral Neuromodulation as Treatment for Chronic Constipation
NA · McMaster University · NCT03819062
This study is testing if low level laser therapy can help people with severe chronic constipation feel better after a series of treatment sessions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 6 Years to 70 Years |
| Sex | All |
| Sponsor | McMaster University (other) |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT03819062 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of low level laser therapy for patients suffering from severe chronic refractory constipation. Participants will undergo High-Resolution Colonic Manometry to assess abnormal coordination between colon motility and recto-anal activity, which indicates a dysfunction in the autonomic nervous system's communication with the colon. The treatment consists of eight sessions of laser therapy over three weeks, with outcomes evaluated through symptom questionnaires and physiological assessments at four and twelve weeks post-treatment. This proof of concept study aims to determine if the therapy provides more benefit than harm.
Who should consider this trial
Good fit: Ideal candidates are patients with severe chronic refractory constipation who have abnormal findings from High-Resolution Colonic Manometry.
Not a fit: Patients who are pregnant, have malignancies, active bleeding, deep vein thrombosis, or are light sensitive may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life for patients with chronic constipation by restoring normal bowel function.
How similar studies have performed: While this approach is novel, similar studies exploring neuromodulation techniques have shown promise in treating other gastrointestinal disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hamilton, Ontario
- McMaster University — Hamilton, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Jihong Chen, MD PhD — McMaster University
- Study coordinator: Jihong Chen, MD PhD
- Email: chen338@mcmaster.ca
- Phone: 2263439909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Constipation, Constipation, spinal cord injury, back pain, High-Resolution Colonic Manometry, Anorectal Manometry