Laser Therapy for Pain After C-Section

(PBMT Trial)

Overseen By Toni Tidy, HBSc, CCRA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: Opioids

Disqualifiers: Language barrier, Multiple pregnancy, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain after a C-section using a special light and laser device called Photobiomodulation Therapy (PBMT). The researchers aim to determine if this treatment can reduce immediate post-surgery pain and ongoing pain lasting more than six weeks, without requiring medications that might affect the baby. Participants will receive either the active laser treatment or a placebo (inactive treatment) for comparison. Women planning a C-section with spinal anesthesia and without ongoing pain issues may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-surgical pain management for future mothers.

Do I have to stop taking my current medications for this trial?

The protocol does not specify if you need to stop taking your current medications. However, if you have a history of chronic pain needing daily opioid medications, you cannot participate in the trial.

What prior data suggests that this device is safe for pain management after C-sections?

Research has shown that photo-biomodulation therapy (PBMT) is generally safe and well-tolerated. This treatment uses low-level lasers and is non-invasive, meaning it doesn't involve surgery or cutting the skin. It has been effectively used to manage pain after surgeries like C-sections.

One study found that PBMT reduced pain without causing harmful side effects. Another study confirmed its safety and acceptance as a method for pain relief. While every treatment can have some risks, current research suggests that PBMT is a safe option for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using photo-biomodulation therapy (PBMT) for managing pain after a C-section because it offers a non-invasive alternative to traditional painkillers like opioids and NSAIDs. Unlike these standard treatments, PBMT uses light to stimulate cellular processes and reduce inflammation, which can potentially speed up recovery and reduce dependence on medications. This approach not only aims to relieve pain more quickly but also minimizes the risk of side effects associated with long-term drug use.

What evidence suggests that this device is effective for pain after C-section?

Research shows that photobiomodulation therapy (PBMT), which uses light and lasers, can help manage pain after a C-section. In this trial, participants will join different treatment arms: one receiving active PBMT and another receiving a placebo. Studies have found that PBMT safely and effectively reduces pain in a non-invasive manner. One study found that PBMT not only eased pain but also improved wound healing. This treatment is appealing because it might reduce the need for pain medications like opioids, which are not ideal after a C-section. Overall, PBMT seems promising for managing pain and aiding recovery after surgery. ^{2 4 5 6 7}

Who Is on the Research Team?

Harsha Shanthanna, MD

Principal Investigator

SJHH and McMaster University

Are You a Good Fit for This Trial?

This trial is for women over 18 years old who are planning to have a C-section with spinal anesthesia. It's designed to help those looking for pain relief options after surgery that won't affect their baby, as traditional strong pain medications might.

Inclusion Criteria

I am a woman over 18 planning to have a C-Section with spinal anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive photo-biomodulation therapy (PBMT) sessions post-surgery to manage pain and improve wound healing

3 days

5 treatment sessions during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain and wound healing assessments

6 weeks

1 visit (in-person)

Long-term Follow-up

Participants are evaluated for chronic post-surgical pain, postpartum depression, and any adverse effects related to PBMT

3 months

What Are the Treatments Tested in This Trial?

Interventions

• PBMT

Trial Overview The study is examining the effectiveness of photo-biomodulation therapy (PBMT), which combines light and laser applied directly to the wound. The treatment will be administered twice daily to see if it reduces post-surgery pain immediately and also six weeks later.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Application of photo-biomodulation

Group II: Placebo Placebo Group 1 Intervention

Inactive PBMT

PBMT is already approved in Canada for the following indications:

Approved in Canada as Photobiomodulation Therapy for:

• Pain relief after caesarean section
• Wound healing

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

In a study of 36 patients undergoing root canal retreatment, low-level laser therapy (LLLT) significantly reduced postoperative pain in the first four days compared to a placebo, indicating its efficacy as a pain management technique.

Patients receiving LLLT required fewer analgesics than those in the placebo group, and no pain was reported during the LLLT application, suggesting it is a safe and effective nonpharmacologic option for managing pain after dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Low-level Laser Therapy on Postoperative Pain after Root Canal Retreatment: A Preliminary Placebo-controlled, Triple-blind, Randomized Clinical Trial. Arslan, H., Doğanay, E., Karataş, E., et al.[2018]

Low Level Laser Therapy (LLLT) significantly improved motor function recovery and reduced hyperalgesia in male rats with spinal cord injury, particularly with a 2-week treatment duration.

LLLT effectively lowered elevated interleukin-6 (IL-6) levels post-injury, suggesting it may serve as a safer alternative to methylprednisolone sodium succinate (MPSS) for managing complications following spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of low level laser therapy on neuropathic pain relief and interleukin-6 expression following spinal cord injury: An experimental study. Mojarad, N., Janzadeh, A., Yousefifard, M., et al.[2019]

Low-level laser therapy (LLLT) significantly reduces immediate postpartum pain in women after cesarean sections, as shown by improved scores on pain scales in a study of 88 participants.

Both doses of LLLT (4 J/cm2 and 2 J/cm2) were effective, with no significant difference in pain relief between the two doses, indicating that LLLT is a safe and effective pain management option post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy improves pain in postcesarean section: a randomized clinical trial. de Holanda Araujo, AMP., de Sena, KRR., da Silva Filho, EM., et al.[2020]

Low-level laser therapy (LLLT) shows promise as a treatment for traumatic brain injury (TBI) by promoting neurogenesis, reducing inflammation, and providing neuroprotection, as supported by both animal and clinical trials.

In studies conducted on mice, the most effective treatment involved pulsed laser irradiation at 10 Hz and specific wavelengths of 660 and 810 nm, while excessive treatment regimens (like 14 days of daily applications) were found to be counterproductive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Low-Level Laser (Light) Therapy for Brain Injury. Thunshelle, C., Hamblin, MR.[2022]

This clinical trial aims to evaluate the effectiveness of photobiomodulation therapy (PBMT) for chronic low back pain (LBP) in 148 patients, with treatment sessions occurring three times a week for four weeks, totaling 12 sessions.

The study will measure pain intensity and disability at multiple time points (after treatment, and at 3, 6, and 12 months) to assess both short-term and long-term effects of PBMT compared to a placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial. Tomazoni, SS., Costa, LDCM., Guimarães, LS., et al.[2022]

Low-Level Laser Phototherapy (LPT) is an effective analgesic method for inflammatory pain, as demonstrated in a study with male Wistar rats, where it significantly reduced mechanical hyperalgesia compared to non-coherent light.

The analgesic effect of LPT is mediated by peripheral opioid receptors, as shown by the blocking of its effect with naloxone, while it does not appear to involve peripheral serotonergic receptors, indicating a specific mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of naloxone and methysergide on the analgesic effects of low-level laser in an experimental pain model. Peres e Serra, A., Ashmawi, HA.[2015]

Low-level laser therapy (LLLT) effectively reduces pain and promotes healing by using coherent light in the 600 to 1000 nm wavelength range, which triggers biochemical changes in cells and has been supported by numerous clinical and experimental studies.

LLLT has shown significant analgesic and anti-inflammatory effects, making it a promising complementary treatment option for managing symptoms in patients with osteoarthritis and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. Dima, R., Tieppo Francio, V., Towery, C., et al.[2019]

Photobiomodulation therapy (PBMT), also known as low-level laser therapy, has been effectively used for over 30 years to treat neurological diseases, utilizing low-powered lasers and increasingly, LEDs.

The therapy works by absorbing photons in cellular structures, which influences oxidative states and affects the expression of proteins related to oxidative stress, inflammation, pain, and neuronal growth, highlighting its potential mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanistic aspects of photobiomodulation therapy in the nervous system. Ramezani, F., Neshasteh-Riz, A., Ghadaksaz, A., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39724020/

Photobiomodulation as part of multimodal analgesia to ... This study aims to evaluate the effectiveness of PBMT as part of existing multimodal analgesia after elective CSs.

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0314010

A protocol for randomized controlled trial | PLOS One This study aims to evaluate the effectiveness of PBMT as part of existing multimodal analgesia after elective CSs.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6347730/

Low-Level Laser on Postoperative Pain After Cesarean Section Low power laser therapy is a good method to reduce postoperative pain due to the fact that it is a safe and non-invasive method which is also accepted by ...

4. trialx.com trialx.com/clinical-trials/listings/274478/photo-biomodulation-therapy-for-pain-relief-after-caesarean-section/

Photo-biomodulation Therapy for Pain Relief After ... This will result in improved maternal satisfaction and wound healing; decrease the use of perioperative opioids; potentially influence a ...

5. researchgate.net researchgate.net/publication/336868400_Low-level_laser_therapy_improves_pain_in_postcesarean_section_a_randomized_clinical_trial

Low-level laser therapy improves pain in postcesarean ... Photobiomodulation therapy (PBMT) uses light-emitting diode (LED) and laser and has suggested potential for improving pain control and wound healing. This ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05738239

Photo-biomodulation Therapy for Pain Relief After ... The investigators are testing the effects of a combined light and laser device (photo-biomodulation therapy; PBMT), used on the wound twice daily, with respect ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11670968/

Photobiomodulation as part of multimodal analgesia to ... Low-level laser therapy improves pain in postcesarean section: a randomized clinical trial. Lasers Med Sci. 2020; 35: 1095–1102. doi ...