Low Level Laser Therapy for Chronic Constipation

Overseen By Jihong Chen, MD PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: NSAIDS, Steroids

Disqualifiers: Pregnancy, Malignancies, Bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 3 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether low-level laser therapy can help people with severe chronic constipation unresponsive to other treatments. The focus is on the therapy's benefits and safety. It targets individuals with bowel movement difficulties due to issues between the colon and rectum. Those with test results confirming this condition and ongoing constipation may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore a new treatment option that could enhance quality of life.

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.

What prior data suggests that low level laser therapy is safe for treating chronic constipation?

Research has shown that low-level laser therapy (LLLT) is generally safe. Studies have found it can help with issues like chronic constipation by regularizing bowel movements and improving stool consistency. In one study, patients experienced fewer accidents related to fecal incontinence and reported an improved quality of life. These studies reported no serious side effects. This suggests LLLT is safe for many, but individual experiences may vary. Always consult a healthcare provider before starting a new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Low level laser therapy (LLLT) is unique because it uses light to stimulate cellular activity in a non-invasive way, offering a novel approach to treating chronic constipation. Unlike traditional treatments like laxatives, dietary changes, or even sacral neuromodulation, which typically involve chemical or electrical interventions, LLLT targets the body’s cells directly with laser light to promote better bowel function. Researchers are excited about LLLT because it could provide relief with fewer side effects, and its potential to improve quality of life for those with severe refractory constipation is significant.

What evidence suggests that low level laser therapy is effective for chronic constipation?

Research suggests that low-level laser therapy (LLLT), which participants in this trial will receive, might help with chronic constipation. One study found that LLLT improved muscle function in areas with injury, leading to better bowel movements. Another study showed that LLLT increased bathroom frequency and made stools easier to pass. It also reduced accidents and improved patients' quality of life. While research continues, these findings suggest that LLLT could be a promising option for those dealing with chronic constipation. ^{1 2 3 4 5}

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

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.

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?

Group I: Refractory Constipation with LLLT Experimental Treatment 1 Intervention

Low level laser therapy (LLLT) will be administered to patients with severe refractory chronic constipation

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

Approved in United States as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence

Approved in European Union as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence
• Chronic constipation

Approved in Canada as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence
• Chronic constipation

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Sacral neuromodulation (SNM) has been shown to have a positive therapeutic effect on lower urinary tract and bowel dysfunction in preclinical studies, with various stimulation parameters yielding acute benefits.

Different stimulation settings, such as low-frequency, high-frequency, bilateral stimulation, and higher pulse widths, demonstrated beneficial effects on both storage and evacuation dysfunction, suggesting that optimizing these parameters could enhance SNM's effectiveness in clinical applications.

NCBI (Pubmed)

pubmed.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. Douven, P., Assmann, R., Breukink, SO., et al.[2022]

Sacral neuromodulation (SNM) is a promising treatment for functional constipation in both children (ages 10-18) and adults, with significant improvements in defecation frequency maintained over a mean follow-up of 47 months.

While both children and adults experienced increased defecation frequency after SNM, adults had a higher frequency than children, and the overall quality of life improvements were limited, raising questions about the cost-effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of intractable constipation treated by sacral neuromodulation: a comparison between children and adults. Janssen, PTJ., Meyer, YM., Van Kuijk, SMJ., et al.[2019]

Sacral neuromodulation (SNM) with the InterStim II system has evolved into a minimally invasive procedure, significantly improving treatment success rates for chronic urinary and bowel dysfunction, with a response rate of approximately 80%.

Recent advancements, such as the tined lead and smaller neurostimulator, have enhanced patient comfort, reduced technical failures, and improved quality of life, making SNM a viable option for patients who do not respond to conservative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. Spinelli, M., Sievert, KD.[2008]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medium-term outcome of sacral nerve modulation for constipation. Govaert, B., Maeda, Y., Alberga, J., et al.[2022]

A systematic review of 17 studies on sacral neuromodulation (SNM) found that adjusting stimulation parameters, such as frequency and pulse width, can enhance treatment efficacy for urinary and bowel dysfunction, with some studies showing no risk of bias.

High-frequency stimulation and specific pulse widths, along with short cycling intervals, were particularly effective in improving outcomes and quality of life for patients, indicating potential for better management of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation Parameters for Sacral Neuromodulation on Lower Urinary Tract and Bowel Dysfunction-Related Clinical Outcome: A Systematic Review. Assmann, R., Douven, P., Kleijnen, J., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 15 patients with slow-transit constipation (STC), sacral nerve modulation (SNM) led to significant improvements in constipation symptoms and quality of life, with a mean improvement of 10 points in the Wexner Constipation Score and 6.2 points in quality of life measures.

The treatment was safe, with no reported complications, and 60% of patients opted for permanent implantation after an initial 4-week trial, indicating its potential as a long-term solution for STC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of slow-transit constipation with sacral nerve modulation. Naldini, G., Martellucci, J., Moraldi, L., et al.[2010]

Sacral neuromodulation (SN) has shown promising efficacy in treating constipation, with over 50% of patients experiencing improvement during temporary neuromodulation and about 90% maintaining results after permanent implantation, based on a review of 10 studies involving 350 procedures.

While SN can be effective, it is associated with a high rate of adverse effects, primarily related to electrode positioning, highlighting the need for careful patient selection and further research to identify predictive factors for successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of sacral neuromodulation for management of constipation. Sharma, A., Bussen, D., Herold, A., et al.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 neuromodulation (SNM) significantly improved constipation symptoms in all 7 patients studied, with defecation frequency increasing from 0.6 to 8.0 times per week and defecation time decreasing from 22.9 to 3.7 minutes after a median follow-up of 4 months.

SNM is a safe and minimally invasive treatment option for patients with intractable constipation, particularly those who have not responded to traditional treatments or surgeries, as evidenced by significant reductions in constipation scores and improvements in patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sacral neuromodulation in the treatment of intractable constipation]. Zheng, J., Li, S., Nie, Y., et al.[2018]

The median lifespan of the InterStim™ and InterStim™ II devices used for sacral nerve neuromodulation is 7.29 years and 5.9 years, respectively, indicating that the newer model has a shorter lifespan than the original.

The shorter lifespan of the InterStim™ II is linked to increased long-term hospital costs, suggesting that while both devices are effective for managing incontinence, the choice of device may impact overall treatment expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment. Daikh, A., Reymond, F., Lombardo, D., et al.[2023]

Sacral neuromodulation (SNM) is a promising treatment for constipation, particularly for patients with idiopathic slow and normal transit constipation who do not respond to standard treatments, although evidence is still limited.

The procedure involves implanting an electrode to modulate neural activity in the large bowel, and while it shows potential benefits, there are risks such as electrode migration and infection, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation for constipation: sacral and transcutaneous stimulation. van Wunnik, BP., Baeten, CG., Southwell, BR.[2011]

Citations

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Laser acupuncture improving functional chronic ... The objective of this study was to compare the effects of laser acupuncture and the commonly used osmotic laxative, lactulose (as the control), ...

2. withpower.com withpower.com/trial/phase-constipation-8-2019-b0bd6

Low Level Laser Therapy for Chronic Constipation SNM treatment significantly improved defecation frequency, stool consistency, and reduced fecal incontinence episodes, while also enhancing quality of life ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9477245/

Modulation of the autonomic nervous system by one session ... In rats, it was shown that TENS improved constipation via modulation of the autonomic nervous system, increased vagal activity and decreased ...

4. ijgii.org ijgii.org/journal/view.html?doi=10.18528/ijgii240062

The effect of low-level laser therapy on external anal ... Conclusions: Two weeks of LLL therapy effectively increased muscle at the EAS injury site, leading to significant, lasting improvements in FI.

5. medicine.healthsci.mcmaster.ca medicine.healthsci.mcmaster.ca/low-level-laser-therapy-for-chronic-refractory-constipation/

Low-level laser therapy for chronic refractory constipation The study is the first study to investigate the treatment of chronic refractory constipation using low-level laser therapy (LLLT), to essentially enhance the ...