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

NCT ID: NCT05345600

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2025-11-23

Brief Summary

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.

Conditions

Perineal Scars; Delivery Complication; Episiotomy; Pain; Treatment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MILTA

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

Group Type: EXPERIMENTAL

MILTA probe

Intervention Type: OTHER

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.

placebo

Group Type: PLACEBO_COMPARATOR

placebo probe

Intervention Type: OTHER

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.

Interventions

MILTA probe

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.

Intervention Type: OTHER

placebo probe

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, Picardie, France

Countries

France

Other Identifiers

PI2021_843_0049

Identifier Type: -

Identifier Source: org_study_id