Laser Therapy for Pain After C-Section

(PBMT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Harsha Shanthanna, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McMaster University

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

C-sections may result in a lot of pain that is distressing to the mother, and can impact bonding with the baby. Although there are medications used to treat strong pain, they are not good to use after C-sections because they can affect the baby. There is a need for a pain management option that can reduce the use of medications. 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 to pain right after surgery, and pain that lasts longer than 6 weeks after surgery.

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 data supports the idea that Laser Therapy for Pain After C-Section is an effective treatment?

The available research shows that Laser Therapy, also known as Low-Level Laser Therapy (LLLT) or Photobiomodulation Therapy (PBMT), has been effective in reducing pain in various conditions. For example, it has been used successfully to manage pain after root canal treatments and in chronic pain conditions like osteoarthritis. These studies highlight its ability to reduce pain and inflammation, suggesting it could be effective for pain after a C-section as well. However, specific data on its use for C-section pain is not provided in the available research. ^{1 2 3 4 5}

What safety data exists for laser therapy for pain after C-section?

The safety data for laser therapy, also known as photobiomodulation therapy (PBMT) or low-level laser therapy (LLLT), indicates it has been used for over 30 years in treating neurological diseases and pain management. It is considered a non-pharmacological therapy with analgesic and anti-inflammatory effects. While specific safety data for post-C-section pain is not detailed, the therapy has been applied in various pain-related conditions, suggesting a general safety profile. However, high-quality evidence for its effectiveness in specific conditions like chronic low back pain is still limited. ^{2 3 4 6 7}

Is the treatment PBMT a promising treatment for pain after a C-section?

Yes, PBMT, also known as Low-Level Laser Therapy, is a promising treatment for pain after a C-section. It helps reduce pain and improve recovery by using light to trigger beneficial changes in cells. Studies show it effectively reduces pain and inflammation, making it a useful non-drug option for pain relief. ^{1 3 4 6 8}

Eligibility Criteria

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.

Treatment Details

Interventions

• PBMT (Other)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

St. Joseph's Healthcare Hamilton Hamilton, Canada

Who Is Running the Clinical Trial?

McMaster University Lead Sponsor

References

1. United States 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. [2018] Low-level laser therapy (LLLT) is a practical, nonpharmacologic technique for reducing pain. This study evaluated the effect of LLLT on postoperative pain after root canal retreatment (RCR).

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

Transcranial Low-Level Laser (Light) Therapy for Brain Injury. [2022] Low-level laser therapy (LLLT) or photobiomodulation (PBM) is a possible treatment for brain injury, including traumatic brain injury (TBI).

3. England pubmed.ncbi.nlm.nih.gov

Mechanistic aspects of photobiomodulation therapy in the nervous system. [2022] Photobiomodulation therapy (PBMT) previously known as low-level laser therapy (LLLT) has been used for over 30 years, to treat neurological diseases. Low-powered lasers are commonly used for clinical applications, although recently LEDs have become popular. Due to the growing application of this type of laser in brain and neural-related diseases, this review focuses on the mechanisms of laser action. The most important points to consider include the photon absorption by intracellular structures; the effect on the oxidative state of cells; and the effect on the expression of proteins involved in oxidative stress, inflammation, pain, and neuronal growth.

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

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. [2019] Low-level laser therapy (LLLT) is a form of light therapy that triggers biochemical changes within cells. Photons are absorbed by cellular photoreceptors, triggering chemical alterations and potential biochemical benefits to the human body. LLLT has been used in pain management for years and is also known as cold laser therapy, which uses low-frequency continuous laser of typically 600 to 1000 nm wavelength for pain reduction and healing stimulation. Many studies have demonstrated analgesic and anti-inflammatory effects provided by photobiomodulation in both experimental and clinical trials.

5. Netherlands 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. [2019] The effect of Low Level Laser Therapy (LLLT) as a non-invasive treatment of spinal cord injury (SCI) is still under investigation. Therefore, the present study aimed to evaluate the effectiveness of LLLT on neuropathic pain and interleukin-6 (IL-6) expression following SCI in male rats.

6. Brazil pubmed.ncbi.nlm.nih.gov

Influence of naloxone and methysergide on the analgesic effects of low-level laser in an experimental pain model. [2015] Although the mechanism of action of laser phototherapy (LPT) is not known, it is a promising analgesic method. The aim of this study was to evaluate whether the action of LPT depends on the activation of peripheral opioid or serotonergic receptors.

7. England 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. [2022] Low back pain (LBP) is one of the largest and most frequent public health problems worldwide. Photobiomodulation therapy (PBMT) is a frequently used non-pharmacological therapy for the treatment of musculoskeletal disorders. However, there is little high-quality scientific evidence that demonstrates the effectiveness of PBMT in the treatment of patients with chronic LBP in the short, medium and long term. Therefore, the objective of this clinical trial is to evaluate the effects of PBMT in patients with chronic non-specific LBP in the short, medium and long term.

8. England pubmed.ncbi.nlm.nih.gov

Low-level laser therapy improves pain in postcesarean section: a randomized clinical trial. [2020] This study aimed to evaluate the effect of low-level laser therapy (LLLT) on immediate postpartum pain relief during cesarean section. A randomized, parallel controlled trial was carried out. In total, 88 women with immediate postpartum were divided into 4 groups: control group (n = 22), placebo group (n = 22), experimental group I (n = 22, dose of 4 J/cm2), and experimental group II (n = 22, dose of 2 J/cm2). The pain measured by Numeric Rating Scale (NRS), algometry, and Global Change Perception Scale (GCPS) was assessed at 12, 20-24, and 44-48 h postpartum. Two LLLT sessions were performed at 12 and 24 h postpartum. A significant interaction was observed between time versus group for NRS F (2.40) = 36.80, p < 0.001 and algometry F (1.70) = 27.18, p < 0.001. GCPS revealed a significant difference between the groups during second (p = 0.04) and third evaluation (p = 0.04). The NRS and algometry presented a large effect size for the experimental groups. LLLT is an efficient method to reduce pain and enhance the GCP in postcesarean section. No significant clinical differences were found between the laser doses.