Low Level Laser Therapy for Bowel Incontinence

(LLLT-FI Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jihong Chen, MD PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McMaster University

Must not be taking: Steroids

Disqualifiers: Pregnancy, Malignancies, Bleeding, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a special light therapy to help people who can't control their bowel movements and haven't been helped by other treatments. The therapy involves multiple sessions over a few weeks. Researchers will check if it improves symptoms and quality of life by looking at questionnaires and physical tests.

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 data supports the effectiveness of the treatment Low Level Laser Therapy (LLLT) 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 these studies focus on wound healing, the positive effects on tissue repair and inflammation suggest potential benefits for other conditions, like bowel incontinence.

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How does low level laser therapy (LLLT) differ from other treatments for bowel incontinence?

Low level laser therapy (LLLT) is unique because it uses light to stimulate biological processes in cells, promoting tissue repair and reducing inflammation, which is different from traditional treatments that may rely on medications or surgical interventions.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

McMaster University Hamilton, Canada

Who Is Running the Clinical Trial?

McMaster University Lead Sponsor

References

1. China pubmed.ncbi.nlm.nih.gov

[Advancement in the research of effect of low level laser therapy on wound healing]. [2015] Low level laser therapy (LLLT) is a therapeutic method which regulates the biological behavior of cells with light. The effects of LLLT consist of promotion of tissue repair, inhibition of inflammation, and relief of pain by promoting or inhibiting the cell proliferation, increasing or decreasing the release of some bioactive substances. Therefore, LLLT is also known as photomodulation. At present, there are many relevant experimental studies of LLLT abroad, and they are also used clinically. This article reviews the effect of LLLT on wound healing.

2. United States pubmed.ncbi.nlm.nih.gov

Low level laser therapy (LLLT) as an effective therapeutic modality for delayed wound healing. [2015] Low level laser therapy (LLLT) is a form of phototherapy that involves the application of low power monochromatic and coherent light to injuries and lesions. It has been used successfully to induce wound healing in nonhealing defects. Other wounds treated with lasers include burns, amputation injuries, skin grafts, infected wounds, and trapping injuries. The unique properties of lasers create an enormous potential for specific therapy of skin diseases. As with any new device, the most efficacious and appropriate use requires an understanding of the mechanisms of light interaction with tissue as well as the properties of the laser itself.

3. India 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. [2022] Low-level laser therapy (LLLT) is based on the principle of biostimulation or biomodulation effect. LLLT after gingivectomy has resulted in better wound healing because of its action on collagen synthesis, angiogenesis, and growth factor release.

4. England pubmed.ncbi.nlm.nih.gov

It is time to test low level laser therapy in Great Britain. [2018] Low level laser therapy (LLLT) has been used in Eastern Europe and Asia for the treatment of a wide range of conditions for many years. Its continued acceptance in these populations reflects the efficacy with which it is regarded both by clinicians and their patients. Although there have been a substantial number of reports on its clinical benefit and some practitioners have used the technique in North America and Australasia it has yet to be subjected to detailed assessment through randomised clinical trials. The purpose of this review is to stimulate interest in the technique and to encourage rigorous research into its potential value.

5. United States pubmed.ncbi.nlm.nih.gov

Effect of pulsing in low-level light therapy. [2021] Low level light (or laser) therapy (LLLT) is a rapidly growing modality used in physical therapy, chiropractic, sports medicine and increasingly in mainstream medicine. LLLT is used to increase wound healing and tissue regeneration, to relieve pain and inflammation, to prevent tissue death, to mitigate degeneration in many neurological indications. While some agreement has emerged on the best wavelengths of light and a range of acceptable dosages to be used (irradiance and fluence), there is no agreement on whether continuous wave or pulsed light is best and on what factors govern the pulse parameters to be chosen.

6. United States pubmed.ncbi.nlm.nih.gov

Low-level laser therapy in dentistry. [2022] Low-level laser therapy (LLLT) is a newly developing technique in dentistry, although it has been used among medical, dental, physiotherapy, and veterinary professions in some parts of the world for decades. LLLT can offer tremendous therapeutic benefits to patients, such as accelerated wound healing and pain relief. There is much to be learned about the mechanisms, recognition of the therapeutic window, and how to properly use these cellular phenomena to reach the treatment goals.