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 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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 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) 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) 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]

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 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 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) 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]

Citations

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

[Advancement in the research of effect of low level laser therapy on wound healing]. [2015]

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

Low level laser therapy (LLLT) as an effective therapeutic modality for delayed wound healing. [2015]

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]

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

It is time to test low level laser therapy in Great Britain. [2018]

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

Effect of pulsing in low-level light therapy. [2021]

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

Low-level laser therapy in dentistry. [2022]