Your session is about to expire
← Back to Search
Other
Active for Pain (PBMT Trial)
N/A
Recruiting
Led By Harsha Shanthanna, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
• Women aged ≥18 years with planned C-Section under spinal anesthesia.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
PBMT Trial Summary
This trial is testing a light+laser device to reduce C-section pain and reduce need for medications that can affect the baby.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of PBMT aren't detailed here, similar therapies sometimes cause mild skin irritation or redness at the site of application. Generally, PBMT is considered low-risk.
PBMT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPBMT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain intensity with movement (elicited by asking the patient to move from supine to sitting position) using 0-10 Numerical Rating Scale
Secondary outcome measures
Incidence of adverse effects due to PBMT
Incidence of patients with clinically important postoperative nausea/vomiting (PONV).
Incidence of persistent pain
+6 moreOther outcome measures
Incidence of any adverse effects related to the use of home-based PBMT
Incidence of chronic postsurgical pain
Incidence of delayed or abnormal wound healing or surgical site infection
+1 moreSide effects data
From 2017 Phase 3 trial • 224 Patients • NCT0237597112%
Pyrexia
11%
Dermatitis diaper
10%
Nasopharyngitis
8%
Retinal haemorrhage
8%
Upper respiratory tract infection
8%
Conjunctival haemorrhage
7%
Gastrooesophageal reflux disease
5%
Cough
5%
Diarrhoea
5%
Anaemia
5%
Pneumonia
4%
Bronchospasm
4%
Inguinal hernia
4%
Rhinitis
4%
Urinary tract infection
3%
Bronchiolitis
3%
Vomiting
3%
Incarcerated inguinal hernia
3%
Anaemia neonatal
3%
Bronchopulmonary dysplasia
3%
Bradycardia
3%
Retinopathy of prematurity
3%
Brain oedema
1%
Cerebellar haemorrhage
1%
Dehydration
1%
Weight decreased
1%
Gastrointestinal haemorrhage
1%
Klebsiella sepsis
1%
Pneumonia staphylococcal
1%
Cardiopulmonary failure
1%
Ileal atresia
1%
Ileal perforation
1%
Escherichia urinary tract infection
1%
Peritonitis
1%
Roseola
1%
Staphylococcal sepsis
1%
Greenstick fracture
1%
Failure to thrive
1%
Gastrointestinal stoma complication
1%
Cataract
1%
Abdominal discomfort
1%
Septic shock
1%
Viral infection
1%
Bronchitis
1%
Respiratory distress
1%
Enterococcal sepsis
1%
Sepsis
1%
Apnoea
1%
Gastroenteritis
1%
Hydrocephalus
1%
Nystagmus
1%
Aspiration
1%
Dependence on oxygen therapy
1%
Cyst
1%
Bone disorder
1%
Haemangioma
1%
Partial seizures
1%
Purpura
1%
Conjunctivitis
1%
Hyperphosphatasaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ranibizumab 0.2 mg
Ranibizumab 0.1 mg
Laser
PBMT Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Application of photo-biomodulation
Group II: PlaceboPlacebo Group1 Intervention
Inactive PBMT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Laser therapy
2013
Completed Phase 4
~870
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,598,136 Total Patients Enrolled
3 Trials studying Pain
1,107 Patients Enrolled for Pain
Harsha Shanthanna, MDPrincipal InvestigatorSJHH and McMaster University
3 Previous Clinical Trials
495 Total Patients Enrolled
1 Trials studying Pain
402 Patients Enrolled for Pain
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study recruiting participants currently?
"According to clinicaltrials.gov, this investigation is currently seeking participants. It was initially advertised on September 1st 2023 and last amended on December 8th of the same year."
Answered by AI
What is the participant size of this clinical experiment?
"That is correct. According to clinicaltrials.gov, this medical trial can now be found recruiting participants since its inception on September 1st 2023 and last update on December 8th 2023. The research requires 180 patients from a single site for participation."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger