MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery

Study Overview
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Brief Summary
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The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for some women. Medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic. The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain : 1- The NPCL (Nano-Pulsed Cold Laser) emissions in coherent infrared light, at 905 nanometers; 2- Non-coherent emissions, pulsed by trichromatic RGB CSM diodes (400 to 650 nm); 3- Continuous non-coherent infrared emission monochromatic diodes at 905 nm; 4- A constant circular magnetic field (200 millitesla) equivalent to the terrestrial magnetic field and 5- The effect of magnetic tunnel which potentiates the light propagation. MILTA® treatment has been shown to be effective in various managements of pain, but has never been used in pain related to perineal scars. This randomized controlled trial aims at assessing MILTA vs placebo to reduce pain related to perineal scars after pregnancy.

Official Title
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A Pilot Randomized Trial Comparing the Use of MILTA vs Placebo for the Management of Pain Related to Perineal Scars Following Delivery

Conditions
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Episiotomy, Perineal Scars, Delivery Complication, Pain, Treatment

Intervention / Treatment
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* Other: MILTA probe
* Other: placebo probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vaginal delivery less than 24h before inclusion perineal scar with pain assessed as > 3/10 with a numerical scale 18-years-old or older registration to the French medical system speaking and writing French written informed consent signed Exclusion Criteria: woman under 18-years-old woman under law liberty restriction women unable to understand the written informed consent no written informed consent signed previous perineal surgery delivery with a caesarian section vaginal delivery with no perineal scar vaginal delivery with infected perineal scar women with restrictions for the use of level 1 analgesic women requiring level 2 or 3 analgesics for other reasons

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MILTA<br>The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain | Other: MILTA probe<br>* Each woman will be included within the 6h after delivery (to ensure at least 2 days with the treatment / placebo). Once the written informed consent is obtained, the patient will be randomized in one of the 2 groups (MILTA or Placebo): 2 sessions are planned (the first one between 6h and 24h after delivery and the second one day after the first session). The woman will be lying on an exam bed. After a skin cleansing, the MILTA probe covered with a specific single use protection will be placed facing the scar. A 10-min session will include 5 min with the analgesia mode on followed with 5 min with the healing mode on in the MILTA group. For the placebo group, the procedure will be identical, with the probe switched OFF. To ensure that the red light is observable in the bedroom in both groups, a second probe will be used, facing the ceiling of the exam bedroom (and not the woman) for the 10 minutes of the procedure.<br>|
| Placebo Comparator: placebo<br> | Other: placebo probe<br>* Each woman will be included within the 6h after delivery (to ensure at least 2 days with the treatment / placebo). Once the written informed consent is obtained, the patient will be randomized in one of the 2 groups (MILTA or Placebo): 2 sessions are planned (the first one between 6h and 24h after delivery and the second one day after the first session). The woman will be lying on an exam bed. After a skin cleansing, the MILTA probe covered with a specific single use protection will be placed facing the scar. A 10-min session will include 5 min with the analgesia mode on followed with 5 min with the healing mode on in the MILTA group. For the placebo group, the procedure will be identical, with the probe switched OFF. To ensure that the red light is observable in the bedroom in both groups, a second probe will be used, facing the ceiling of the exam bedroom (and not the woman) for the 10 minutes of the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain level | Pain Level will be determined with EQ-5D instrument. The EQ-5D index scores were derived from the current UK tariff, which has a maximum value of 1 and a minimum value of -0.59. EQ-5D comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding. | day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perineal scars, Delivery Complication, episiotomy, Pain, treatment