Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Immediate Post-partum Situation

Study Overview
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Brief Summary
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Photobiomodulation (PBM), evaluated in this study, will be delivered by a CE marked class IIa medical device (MILTA technology), composed of a panel that gathers 18 emitters. This is an innovative, alternative, soft technology, based on a cross action of LED light emission, a low intensity nanopulsed laser and a magnetic tunnel. The sessions last 10 minutes each, in total in the study two sessions will be delivered.

Detailed Description
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In a woman's life, maternity is an important stage that is not without consequences, not only in daily life but also in future life. Perineal pain syndrome is a problem frequently encountered in the postpartum period and the review of the literature shows that 95 to 100% of women who have given birth by the vaginal way and who present perineal lesions, suffer from perineal pain at 24 hours of the delivery and approximately 60% of them remain painful at 7 days of the delivery. This incidence can decrease to 42% and 11% respectively in the absence of perineal lesions. Pain in the postpartum period can not only limit a woman's mobility and affect her quality of life, but can also interfere with the care of her child and thus with the establishment of a good mother-child relationship, and thus prevent her from fulfilling her new role as a mother. Finally, acute pain that is not treated can become chronic and affect long-term physical and psychological health. Pain management in the immediate postpartum period currently involves the use of level 1 analgesics (paracetamol, NSAIDs), the effectiveness of which is uncertain, and level 2 analgesics (weak morphine derivatives, Acupan, Tramadol), which are more effective for pain, but are sometimes badly tolerated or contraindicated in the case of breastfeeding. Recently, several publications tend to show that alternative solutions would allow a more satisfactory approach to the management of painful patients. In this study, the investigators propose to evaluate the benefit of an innovative analgesic treatment in the immediate postpartum period using photobiomodulation (PBM) by evaluating pain using a Visual Analog Scale. PBM, discovered in the 1950s, uses the properties of light. The PBM corresponds to all the non-thermal and non-cytotoxic biological effects caused by the exposure of tissues to light sources in the visible and near-infrared range. More precisely, certain wavelengths of the light spectrum (red-infrared) lead to a cascade of biological effects within the cell: reduction of pain, regulation of inflammation and acceleration of the healing process. The objective of this study is to analyze the possibility of replacing chemical medication by a non-invasive, painless technology in patients who have just given birth. This technology is already used for anti-inflammatory and analgesic actions in indications such as stomatology, rheumatology, post-operation and traumatology. This is part of the field of NMIs (non-medicinal interventions).

Official Title
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Evaluation of the Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Patients in Immediate Post-partum Situation

Conditions
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Pelvic Pain

Intervention / Treatment
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* Device: MILTA Device
* Device:  control 1  fake MILTA device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman aged 18 years or older Primi or multiparous patient Natural childbirth, regardless of the method of extraction (spontaneous, vacuum, forceps), and damage to the perineum (simple tear, episiotomy, obstetric anal sphincter injury) Patients affiliated to a health insurance plan Agreeing to participate in the study and having signed an informed consent Exclusion Criteria: Immediate complications related to the childbirth and requiring management in the continuing care unit (delivery haemorrhage, eclampsia, etc.) Severe neonatal complications requiring reanimation. Patient with a cardiac pacemaker Presence of a disease and/or taking photo-sensitising treatment Patient under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, adaptive, prospective, three-arm randomized, controlled, double-blind study for 2 arms. 3 groups will be constituted, according to a 1:3:3 ratio: 1 group  control 1  with 2 sessions of PBM ( fake device). 1 experimental group with 2 sessions of PBM (real device) 1 group  control 2  with standard pain management (i.e. medication).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator:  control 1  fake MILTA device<br>Fake device (control 1) which emits 10% red light (and no infrared) so that the difference between the two machines cannot be seen with the naked eye. The magnets present in the real device are absent in the fake machine and replaced by inert materials of the same mass. | Device:  control 1  fake MILTA device<br>* Patients in group control 1 will each receive 2 sessions of PBM in this study, the first session within 24 hours of delivery, and the second session 24 hours after the first session.<br>|
| Experimental: MILTA Device<br>The MILTA device used for the study is composed of a panel which gathers 18 emitters composed of red, green and blue LEDs, 3 nanopulsed infrared laser diodes (cold laser), 3 infrared diodes and a permanent magnet | Device: MILTA Device<br>* Patients in MILTA Device group will each receive 2 sessions of PBM in this study, the first session within 24 hours of delivery, and the second session 24 hours after the first session.<br>|
| No Intervention:  control 2  standard pain management with medication<br>In first intention: PARACETAMOL: max 1 g x 4 / 24 h Second intention: IBUPROFEN: max 100 mg x 2 for 48 h Third intention: ACUPAN 20 mg in sugar 3 times per 24 h Last intention: ACTISKENAN 10 mg x 4 / 24 h | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effectiveness of photobiomodulation (PBM) on pain in immediate postpartum patients | Evaluated the superiority of the experimental group (MILTA device) to control 1 (fake device) using a Visual Analog Scale (VAS) collected before and after pain management (1st session of PBM) | 30 minutes after first PBM session for the experimental and control 1 groups | 
| Evaluation of the effectiveness of photobiomodulation on pain in immediate postpartum patients | Evaluated the non-inferiority with of the experimental group (MILTA device) to control 2 (standard of care) using a Visual Analog Scale (VAS) collected before and after pain management | 30 minutes after first PBM session for the experimental group or 30 minutes after analgesic treatment for the group control 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effectiveness of photobiomodulation on pain after the second PBM session | Evaluated the superiority of the experimental group (MILTA device) to control 1 (fake device) using a Visual Analog Scale (VAS) collected before and after pain management (2nd session of PBM) | 30 minutes after second PBM session for the experimental and control 1 groups | 
| Characterisation of pain | Pain will be characterised using the shortened QDSA questionnaire. The control groups will be compared with the MILTA device. | 30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2 | 
| Characterisation of pain | Pain will be characterised using the shortened QDSA questionnaire. The control groups will be compared with the MILTA device. | 30 minutes after second PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2 (Day 1) | 
| Evaluation of the total quantity of analgesics consumed during the hospital stay | Recording of the type and dose of analgesics consumed. | through the hospital stay, an average of 2 or 3 days | 
| Evaluation of the improvement of postpartum comfort | Postpartum confort will be assessed using 5 modalities scale | 30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2 | 
| Evaluation of the improvement of postpartum comfort | Postpartum confort will be assessed using 5 modalities scale | 30 minutes after second PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2 (Day 1) | 
| Evaluation of the involvement of caregivers during the hospital stay | Recording the number of calls to the healthcare team related to pain | through the hospital stay, an average of 2 or 3 days | 
| Safety evaluation | Adverse event record | through study completion, an average of 10 days |