Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896034
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2021-04-29
Brief Title:
Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Immediate Post-partum Situation
Sponsor:
Elsan
Organization:
Elsan
Study Overview
Official Title:
Evaluation of the Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Patients in Immediate Post-partum Situation
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womans 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 womans 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
Pain in the postpartum period can not only limit a womans 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A00447-32 | OTHER | ANSM | None |