Pelvic PainNCT04896034
Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Immediate Post-partum Situation
A study testing MILTA Device in people with Pelvic Pain, run by Elsan at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- MILTA Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2021to 12 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Patients in Immediate Post-partum Situation
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.
Read the 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).
- Conditions
- Pelvic Pain
- Being tested
- MILTA Device, " control 1 " fake MILTA device
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILTA DeviceDevice
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.
" control 1 " fake MILTA deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| " control 1 " fake MILTA device | Placebo comparator | Fake device (control 1) which emits 10% red light (and no infrared) so that the difference between the two machines cannot be seen with the naked eye. The magnets present in the real device are absent in the fake machine and replaced by inert materials of the same mass. Receives: Device: " control 1 " fake MILTA device |
| MILTA Device | Experimental | The MILTA device used for the study is composed of a panel which gathers 18 emitters composed of red, green and blue LEDs, 3 nanopulsed infrared laser diodes (cold laser), 3 infrared diodes and a permanent magnet Receives: Device: MILTA Device |
| " control 2 " standard pain management with medication | No intervention | In first intention: PARACETAMOL: max 1 g x 4 / 24 h Second intention: IBUPROFEN: max 100 mg x 2 for 48 h Third intention: ACUPAN 20 mg in sugar 3 times per 24 h Last intention: ACTISKENAN 10 mg x 4 / 24 h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effectiveness of photobiomodulation (PBM) on pain in immediate postpartum patients
Evaluated 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)
Measured: 30 minutes after first PBM session for the experimental and control 1 groups
Evaluation of the effectiveness of photobiomodulation on pain in immediate postpartum patients
Evaluated 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
Measured: 30 minutes after first PBM session for the experimental group or 30 minutes after analgesic treatment for the group control 2
Secondary outcomes (8)
Evaluation of the effectiveness of photobiomodulation on pain after the second PBM session
Evaluated 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)
Measured: 30 minutes after second PBM session for the experimental and control 1 groups
Characterisation of pain
Pain will be characterised using the shortened QDSA questionnaire. The control groups will be compared with the MILTA device.
Measured: 30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2
Characterisation of pain
Pain will be characterised using the shortened QDSA questionnaire. The control groups will be compared with the MILTA device.
Measured: 30 minutes after second PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2 (Day 1)
Evaluation of the total quantity of analgesics consumed during the hospital stay
Recording of the type and dose of analgesics consumed.
Measured: through the hospital stay, an average of 2 or 3 days
Evaluation of the improvement of postpartum comfort
Postpartum confort will be assessed using 5 modalities scale
Measured: 30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2
Evaluation of the improvement of postpartum comfort
Postpartum confort will be assessed using 5 modalities scale
Measured: 30 minutes after second PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2 (Day 1)
Evaluation of the involvement of caregivers during the hospital stay
Recording the number of calls to the healthcare team related to pain
Measured: through the hospital stay, an average of 2 or 3 days
Safety evaluation
Adverse event record
Measured: through study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start6 May 2021
- Primary completion30 Apr 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Claude ANTON, MD, Principal investigator, Clinique la Chataigneraie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896034
- Sponsor's protocol ID
- PBM study
- Other IDs
- 2020-A00447-32
- Status last verified
- Feb 2024
- First submitted
- 29 Apr 2021
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Persico G, Vergani P, Cestaro C, Grandolfo M, Nespoli A. Assessment of postpartum perineal pain after vaginal delivery: prevalence, severity and determinants. A prospective observational study. Minerva Ginecol. 2013 Dec;65(6):669-78.
PubMed 24346253Morin C, Leymarie MC. La douleur périnéale en post-partum: revue de la littérature. La Revue Sage-femme (2013) 12; 263-268
Manresa M, Pereda A, Bataller E, Terre-Rull C, Ismail KM, Webb SS. Incidence of perineal pain and dyspareunia following spontaneous vaginal birth: a systematic review and meta-analysis. Int Urogynecol J. 2019 Jun;30(6):853-868. doi: 10.1007/s00192-019-03894-0. Epub 2019 Feb 15.
PubMed 30770967Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
PubMed 15507941Turmo M, Echevarria M, Rubio P, Almeida C. Development of chronic pain after episiotomy. Rev Esp Anestesiol Reanim. 2015 Oct;62(8):436-42. doi: 10.1016/j.redar.2014.10.008. Epub 2014 Dec 30. English, Spanish.
PubMed 25555717HAS. Douleur chronique: reconnaître le syndrome douloureux chronique, l'évaluer et orienter le patient. Consensus formalisé - December 2008
Skovlund E, Fyllingen G, Landre H, Nesheim BI. Comparison of postpartum pain treatments using a sequential trial design. I. Paracetamol versus placebo. Eur J Clin Pharmacol. 1991;40(4):343-7. doi: 10.1007/BF00265841.
PubMed 2050168Behotas S, Chauvin A, Castiel J, Martin A, Boureau F, Barrat J, Lienhart A. [Analgesic effect of ibuprofen in pain after episiotomy]. Ann Fr Anesth Reanim. 1992;11(1):22-6. doi: 10.1016/s0750-7658(05)80316-8. French.
PubMed 1443811Gabelle C, Cassa S, Bouvard M, Knoepffler F. Intérêts des anti-inflammatoires non stéroïdes dans les douleurs périnéales du post-partum. J Gyneco. Obst. Biol. Reprod (2004) 33(1): 67 (10)
Wehrle M. Prise en charge de la douleur post-épisiotomie en suites de couches: Analyse des pratiques professionnelles à la Maternité Régionale Universitaire de Nancy. Mémoire Université de Lorraine (2015) hal-02110831.
Battut A, Nizard J. [Impact of pelvic floor muscle training on prevention of perineal pain and dyspareunia in postpartum]. Prog Urol. 2016 Mar;26(4):237-44. doi: 10.1016/j.purol.2015.09.006. Epub 2015 Oct 9. French.
PubMed 26455776Golka M. Haute fréquence et douleur périnéale du post-partum. Mémoire Université d'Aix Marseille (2017) dumas-01646228
Boureau F, Luu M. Méthodes d'évaluation de la douleur. Douleur et Analgésie (1988) 6; 1(2): 65-78.
Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361. doi: 10.3934/biophy.2017.3.337. Epub 2017 May 19.
PubMed 28748217Moreira Rocha Jr A. Et al. Effects of Low-Level Laser Therapy on the progress of wound healing in humans: the contribution of in vitro and in vivo experimental studies. J. Vas. Bras 2007; 6(3): 258-266
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Patients in Immediate Post-partum Situation
- ClinicalTrials.gov ID
- NCT04896034
- Acronym / sponsor ID
- PBM study
- Conditions
- Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| " control 1 " fake MILTA device | Placebo comparator | Device: " control 1 " fake MILTA deviceFake device (control 1) which emits 10% red light (and no infrared) so that the difference between the two machines cannot be seen with the naked eye. The magnets present in the real device are absent in the fake machine and replaced by inert materials of the same mass. |
| MILTA Device | Experimental | Device: MILTA DeviceThe MILTA device used for the study is composed of a panel which gathers 18 emitters composed of red, green and blue LEDs, 3 nanopulsed infrared laser diodes (cold laser), 3 infrared diodes and a permanent magnet |
| " control 2 " standard pain management with medication | No intervention | –In first intention: PARACETAMOL: max 1 g x 4 / 24 h Second intention: IBUPROFEN: max 100 mg x 2 for 48 h Third intention: ACUPAN 20 mg in sugar 3 times per 24 h Last intention: ACTISKENAN 10 mg x 4 / 24 h |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MILTA DevicePatients 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 | MILTA Device |
| " control 1 " fake MILTA devicePatients 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. | Device | " control 1 " fake MILTA device |
Primary outcome
Evaluation of the effectiveness of photobiomodulation (PBM) on pain in immediate postpartum patients
Time frame: 30 minutes after first PBM session for the experimental and control 1 groups
Evaluated 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 patients
Time frame: 30 minutes after first PBM session for the experimental group or 30 minutes after analgesic treatment for the group control 2
Evaluated 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
8 secondary outcomes
Evaluation of the effectiveness of photobiomodulation on pain after the second PBM session
Time frame: 30 minutes after second PBM session for the experimental and control 1 groups
Characterisation of pain
Time frame: 30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2
Characterisation of pain
Time frame: 30 minutes after second PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2 (Day 1)
Evaluation of the total quantity of analgesics consumed during the hospital stay
Time frame: through the hospital stay, an average of 2 or 3 days
Evaluation of the improvement of postpartum comfort
Time frame: 30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2
Evaluation of the improvement of postpartum comfort
Time frame: 30 minutes after second PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2 (Day 1)
Evaluation of the involvement of caregivers during the hospital stay
Time frame: through the hospital stay, an average of 2 or 3 days
Safety evaluation
Time frame: through study completion, an average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 24346253Persico G, Vergani P, Cestaro C, Grandolfo M, Nespoli A. Assessment of postpartum perineal pain after vaginal delivery: prevalence, severity and determinants. A prospective observational study. Minerva Ginecol. 2013 Dec;65(6):669-78.
- BackgroundMorin C, Leymarie MC. La douleur périnéale en post-partum: revue de la littérature. La Revue Sage-femme (2013) 12; 263-268
- Background: PubMed 30770967Manresa M, Pereda A, Bataller E, Terre-Rull C, Ismail KM, Webb SS. Incidence of perineal pain and dyspareunia following spontaneous vaginal birth: a systematic review and meta-analysis. Int Urogynecol J. 2019 Jun;30(6):853-868. doi: 10.1007/s00192-019-03894-0. Epub 2019 Feb 15.
- Background: PubMed 15507941Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
- Background: PubMed 25555717Turmo M, Echevarria M, Rubio P, Almeida C. Development of chronic pain after episiotomy. Rev Esp Anestesiol Reanim. 2015 Oct;62(8):436-42. doi: 10.1016/j.redar.2014.10.008. Epub 2014 Dec 30. English, Spanish.
- BackgroundHAS. Douleur chronique: reconnaître le syndrome douloureux chronique, l'évaluer et orienter le patient. Consensus formalisé - December 2008
- Background: PubMed 2050168Skovlund E, Fyllingen G, Landre H, Nesheim BI. Comparison of postpartum pain treatments using a sequential trial design. I. Paracetamol versus placebo. Eur J Clin Pharmacol. 1991;40(4):343-7. doi: 10.1007/BF00265841.
- Background: PubMed 1443811Behotas S, Chauvin A, Castiel J, Martin A, Boureau F, Barrat J, Lienhart A. [Analgesic effect of ibuprofen in pain after episiotomy]. Ann Fr Anesth Reanim. 1992;11(1):22-6. doi: 10.1016/s0750-7658(05)80316-8. French.
- BackgroundGabelle C, Cassa S, Bouvard M, Knoepffler F. Intérêts des anti-inflammatoires non stéroïdes dans les douleurs périnéales du post-partum. J Gyneco. Obst. Biol. Reprod (2004) 33(1): 67 (10)
- BackgroundWehrle M. Prise en charge de la douleur post-épisiotomie en suites de couches: Analyse des pratiques professionnelles à la Maternité Régionale Universitaire de Nancy. Mémoire Université de Lorraine (2015) hal-02110831.
- Background: PubMed 26455776Battut A, Nizard J. [Impact of pelvic floor muscle training on prevention of perineal pain and dyspareunia in postpartum]. Prog Urol. 2016 Mar;26(4):237-44. doi: 10.1016/j.purol.2015.09.006. Epub 2015 Oct 9. French.
- BackgroundGolka M. Haute fréquence et douleur périnéale du post-partum. Mémoire Université d'Aix Marseille (2017) dumas-01646228
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Claude ANTON, MD principal investigator
Clinique la Chataigneraie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MILTA Device in people with Pelvic Pain, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effectiveness of photobiomodulation (PBM) on pain in immediate postpartum patients (time frame: 30 minutes after first PBM session for the experimental and control 1 groups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04896034, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.