Low Level Laser Therapy for Bowel Incontinence

(LLLT-FI Trial)

Overseen By Jan D Huizinga, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: 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: Unknown

Duration: 3 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether low-level laser therapy (LLLT) can help individuals with severe fecal incontinence unresponsive to other treatments. The therapy uses lasers to stimulate nerves in the lower back area and targets those who frequently experience loss of bowel control despite other solutions. Individuals with tattoos or certain medical conditions around the treatment area are not eligible. The study aims to determine if this laser treatment can make a positive difference without using a placebo for comparison. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

If you are taking steroids, you will need to stop them to participate in this trial.

What prior data suggests that low level laser therapy is safe for treating bowel incontinence?

Research has shown that low-level laser therapy (LLLT) may help treat conditions like fecal incontinence. Studies have found that using LLLT for two weeks can significantly improve muscle function in injured areas, leading to lasting improvements in bowel control. Evidence also suggests that LLLT might help balance the autonomic nervous system, which affects bowel movements.

Although these results are encouraging, researchers are still studying the safety of LLLT. As this is an early-stage study, they continue to examine its effectiveness and safety for people. However, similar treatments have generally been well-tolerated. Prospective participants should know that researchers are carefully studying the potential benefits of LLLT to ensure it is more helpful than harmful for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Low level laser therapy (LLLT) is unique because it uses light energy to stimulate healing and modulate nerve function, offering a non-invasive alternative for bowel incontinence. Unlike traditional treatments like medications or surgical interventions, LLLT targets the sacral nerves through a process called photobiomodulation, which may enhance nerve control over bowel movements. Researchers are excited because this method could potentially reduce symptoms without the side effects associated with drugs or the risks of surgery, and it provides a novel approach that might improve the quality of life for patients with bowel incontinence.

What evidence suggests that low level laser therapy might be an effective treatment for bowel incontinence?

Research has shown that Low Level Laser Therapy (LLLT), which participants in this trial will receive, can improve bowel incontinence. In one study, two weeks of LLLT increased muscle strength at the injury site of the external anal sphincter, leading to significant and lasting improvements in bowel control. LLLT promotes cell growth and repair, aiding in wound healing, reducing swelling, and relieving pain. Another study suggested that LLLT may restore involuntary nerve function, potentially improving chronic bowel movement disorders. Overall, these findings suggest LLLT may effectively treat severe, hard-to-treat bowel incontinence. ^{1 2 3 4 6}

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 individuals with severe fecal incontinence, which means they have trouble controlling their bowel movements. It's not open to pregnant people, those on steroids, anyone with active deep vein thrombosis or bleeding in the treatment area, light-sensitive patients, or if there are tattoos or known cancers where the therapy will be applied.

Inclusion Criteria

I experience loss of bowel control.

Exclusion Criteria

You have tattoos in the area where the treatment will be done.

I am currently experiencing bleeding in the area that needs treatment.

You are sensitive to light.

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 fecal incontinence over 3 weeks, with a total of 8 sessions

3 weeks

Follow-up

Participants are monitored for changes in fecal incontinence episodes, symptoms score, and quality of life at 4 and 12 weeks after the start of treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low level laser therapy (LLLT)

Trial Overview The study is testing low level laser therapy (LLLT) to see if it helps patients with severe refractory fecal incontinence. There isn't a placebo group being compared against; this is an initial test of the concept to understand its effects.

How Is the Trial Designed?

Group I: Incontinence and low level laser therapy Experimental Treatment 1 Intervention

Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence

Low level laser therapy (LLLT) is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Low-level laser therapy for:

• Pain relief
• Wound healing
• Musculoskeletal conditions
• Fecal incontinence (investigational)

Approved in Canada as Low-level laser therapy for:

• Pain relief
• Wound healing
• Musculoskeletal conditions

Approved in European Union as Low-level laser therapy for:

• Pain relief
• Wound healing
• Musculoskeletal conditions

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Low-level laser therapy (LLLT) is an emerging technique in dentistry that has been used effectively in various medical fields for decades, providing benefits like faster wound healing and pain relief.

Understanding the mechanisms of LLLT and how to optimize its use is crucial for achieving the best treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy in dentistry. Sun, G., Tunér, J.[2022]

In a split-mouth controlled clinical trial involving 40 patients, low-level laser therapy (LLLT) significantly improved wound healing after gingivectomy, as evidenced by smaller stained areas on the treated side compared to controls.

The positive effects of LLLT on wound healing were observed on both the 7th and 30th postoperative days, suggesting its potential as an effective adjunctive treatment in dental surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of low-level laser therapy on wound healing and patients' response after scalpel gingivectomy: A randomized clinical split-mouth study. Kohale, BR., Agrawal, AA., Raut, CP.[2022]

Low level light therapy (LLLT) is effective for promoting wound healing, reducing pain and inflammation, and preventing tissue death, making it a valuable tool in various medical fields.

There is preliminary evidence suggesting that pulsed light may have distinct effects compared to continuous wave light, but more research is needed to clarify these differences and optimize treatment parameters for specific conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of pulsing in low-level light therapy. Hashmi, JT., Huang, YY., Sharma, SK., et al.[2021]

Low level laser therapy (LLLT) effectively promotes tissue repair and reduces inflammation, making it a valuable tool for enhancing wound healing.

LLLT works by regulating cell behavior through light, influencing cell proliferation and the release of bioactive substances, which contributes to its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advancement in the research of effect of low level laser therapy on wound healing]. Mao, HS., Yao, M., Fang, Y.[2015]

Low level laser therapy (LLLT) has been widely used and accepted in Eastern Europe and Asia for various medical conditions, indicating its perceived efficacy among clinicians and patients.

Despite its popularity and reported clinical benefits, LLLT has not yet undergone thorough evaluation through randomized clinical trials in North America and Australasia, highlighting a need for more rigorous research to assess its true value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It is time to test low level laser therapy in Great Britain. Moshkovska, T., Mayberry, J.[2018]

Low level laser therapy (LLLT) effectively promotes wound healing in various types of injuries, including burns and infected wounds, showcasing its potential in treating nonhealing defects.

Understanding the mechanisms of how laser light interacts with tissue is crucial for optimizing the efficacy and safety of LLLT in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level laser therapy (LLLT) as an effective therapeutic modality for delayed wound healing. Hawkins, D., Houreld, N., Abrahamse, H.[2015]

Citations

1. 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.

2. withpower.com withpower.com/trial/phase-fecal-incontinence-8-2019-ff284

Low Level Laser Therapy for Bowel Incontinence Research shows that Low Level Laser Therapy (LLLT) helps with wound healing, reduces inflammation, and relieves pain by promoting cell growth and repair. While ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03825575

Sacral Neuromodulation as Treatment for Fecal Incontinence The objective of this study is to investigate if low level laser therapy will do more good than harm for patients with severe refractory fecal incontinence. It ...

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

Modulation of the autonomic nervous system by one session ... These results warrant a study into the effects of LLLT on restoring autonomic dysfunction in chronic refractory colonic motility disorders.

5. researchgate.net researchgate.net/publication/385440440_The_effect_of_low-level_laser_therapy_on_external_anal_sphincter_repair_and_treatment_of_fecal_incontinence_A_double-blind_randomized_controlled_clinical_trial

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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3096428/

New Options for the Treatment of Fecal Incontinence - PMC The newest injectable therapy involves the injection of carbon-coated beads (the ACYST procedure) in the in 4–8 quadrants around the anal canal and lower rectum ...