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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04896034
Enrollment
480
Registered
2021-05-21
Start date
2021-05-06
Completion date
2023-05-12
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Pain

Brief summary

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

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).

Interventions

DEVICEMILTA Device

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.

DEVICE control 1 fake MILTA device

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.

Sponsors

Elsan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Masking description

The experimental group (real device) and the control 1 group ( fake device) will be in double-blind, neither the investigator nor the patient will know the allocated group.

Intervention 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).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the effectiveness of photobiomodulation (PBM) on pain in immediate postpartum patients30 minutes after first PBM session for the experimental and control 1 groupsEvaluated 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)
Evaluation of the effectiveness of photobiomodulation on pain in immediate postpartum patients30 minutes after first PBM session for the experimental group or 30 minutes after analgesic treatment for the group control 2Evaluated 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

Secondary

MeasureTime frameDescription
Evaluation of the total quantity of analgesics consumed during the hospital staythrough the hospital stay, an average of 2 or 3 daysRecording of the type and dose of analgesics consumed.
Evaluation of the improvement of postpartum comfort30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2Postpartum confort will be assessed using 5 modalities scale
Evaluation of the effectiveness of photobiomodulation on pain after the second PBM session30 minutes after second PBM session for the experimental and control 1 groupsEvaluated 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)
Safety evaluationthrough study completion, an average of 10 daysAdverse event record
Evaluation of the involvement of caregivers during the hospital staythrough the hospital stay, an average of 2 or 3 daysRecording the number of calls to the healthcare team related to pain
Characterisation of pain30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2Pain will be characterised using the shortened QDSA questionnaire. The control groups will be compared with the MILTA device.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026