20 Participants Needed

Low Level Laser Therapy for Chronic Constipation

JD
JC
Overseen ByJihong Chen, MD PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: McMaster University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

JC

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

My tests show my colon and rectum are not working together properly.
I have severe, long-lasting constipation that doesn't improve with treatment.

Exclusion Criteria

I am currently experiencing bleeding in the area that needs treatment.
I have cancer in the area where treatment is planned.
You are pregnant.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low level laser therapy for severe refractory chronic constipation

3 weeks
8 sessions

Follow-up

Participants are monitored for changes in symptoms, quality of life, and physiological assessments

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sacral Neuromodulation
Trial Overview The study is testing low level laser therapy to see if it can help people with severe chronic constipation. This proof of concept study does not include a placebo group; all participants will receive the actual laser therapy to assess its effectiveness.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Refractory Constipation with LLLTExperimental Treatment1 Intervention

Sacral Neuromodulation is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as InterStim for:
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Approved in European Union as InterStim for:
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Approved in Canada as InterStim for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Published Research Related to This Trial

A consensus was reached among 22 European specialists on 43 out of 50 key areas regarding the use of sacral nerve stimulation (SNS) for treating fecal incontinence and constipation, indicating a strong agreement on best practices.
The findings from this modified Delphi process, which included a systematic review of 393 articles, provide a benchmark for safe and effective implementation of SNS/SNM in clinical settings across Europe.
Sacral nerve stimulation for faecal incontinence and constipation: a European consensus statement.Maeda, Y., O'Connell, PR., Lehur, PA., et al.[2022]
In a study of 59 children and adolescents with chronic refractory constipation, noninvasive sacral neuromodulation (SNM) showed an impressive 86% overall responsiveness compared to only 39% in the conventional treatment group, highlighting its efficacy.
SNM treatment significantly improved defecation frequency, stool consistency, and reduced fecal incontinence episodes, while also enhancing quality of life scores, indicating it is a promising alternative to more invasive treatments.
Noninvasive Sacral Neuromodulation in Children and Adolescents: A Case-Control Study of Patients With Chronic Refractory Constipation.Diez, S., Kirchgatter, A., Adam, D., et al.[2023]
Sacral nerve modulation is an effective treatment for constipation that has not responded to conservative methods, showing significant improvement in Wexner constipation scores from a mean of 17.0 to 10.2 after the initial evaluation phase.
However, only 52% of patients continued with the treatment at the latest follow-up, indicating that while the therapy can be effective, its long-term sustainability may be a concern, particularly as younger patients were more likely to benefit from the initial evaluation phase.
Medium-term outcome of sacral nerve modulation for constipation.Govaert, B., Maeda, Y., Alberga, J., et al.[2022]

Citations

Sacral nerve stimulation for faecal incontinence and constipation: a European consensus statement. [2022]
Noninvasive Sacral Neuromodulation in Children and Adolescents: A Case-Control Study of Patients With Chronic Refractory Constipation. [2023]
Medium-term outcome of sacral nerve modulation for constipation. [2022]
[Sacral neuromodulation in the treatment of intractable constipation]. [2018]
Review of sacral neuromodulation for management of constipation. [2014]
Treatment of slow-transit constipation with sacral nerve modulation. [2010]
Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. [2008]
Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment. [2023]
Neuromodulation for constipation: sacral and transcutaneous stimulation. [2011]
10.United Statespubmed.ncbi.nlm.nih.gov
Sacral Neuromodulation for Lower Urinary Tract and Bowel Dysfunction in Animal Models: A Systematic Review With Focus on Stimulation Parameter Selection. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Stimulation Parameters for Sacral Neuromodulation on Lower Urinary Tract and Bowel Dysfunction-Related Clinical Outcome: A Systematic Review. [2022]
Long-term outcome of intractable constipation treated by sacral neuromodulation: a comparison between children and adults. [2019]
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