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

Centre Hospitalier Universitaire, Amiens

Status: Active, not recruiting

Conditions: Treatment; Episiotomy; Perineal Scars; Pain; Delivery Complication

Treatments: Other: MILTA probe; Other: placebo probe

Study type: Interventional

Funder types: Other

Identifiers

NCT05345600

PI2021_843_0049

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups, including a placebo group

MILTA

Experimental group

Description:

The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain

Treatment:

Other: MILTA probe

placebo

Placebo Comparator group

Treatment:

Other: placebo probe