Low-back Pain During Pregnancy and Its Psycho-social Implications
NCT ID: NCT04682002
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
75 participants
INTERVENTIONAL
2020-12-15
2021-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OMT + multidisciplinary path
Patients in the experimental group will follow the obstetrician's and multidisciplinary path which provides osteopathic treatments, mindfulness, yoga, clinical nutrition, coaching and usual obstetric care.
Osteopathic manipulative treatment
OMT will be used to treat pregnancy women after having performed a manual osteopathic assessment. The first osteopathic evaluation is carried out during the 12th week, with the possibility to undertake a personalized treatment built on the needs of the single patient; the chosen techniques are based on the collected data by the operator. A "black-box" type of treatment is undertaken.
Mindfulness
Mindfulness group weekly meetings. Mindfulness practices consist of cognitive and behavioral treatments for depression and anxiety, including mindfulness-based stress reduction and mindfulness-based cognitive therapy.
Yoga
Weekly yoga group meetings. Yoga is a mind-body practice that encompasses a system of postures, deep breathing, and meditation. In this context, yoga practice is adapted to pregnancy with the aim of benefit women who suffer from anxiety, depression, stress, low back pain, and sleep disturbances.
Clinical nutrition
Nutritional advice to all women participating in the study at 12 weeks of pregnancy, with the possibility of starting an individualized path.
Coaching
There will be five personalized coaching sessions during the pregnancy.
Usual care
Patients in control group will continue the routine obstetrical care as established by international guidelines
Usual care
Administration of routine care based on international guidelines
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Osteopathic manipulative treatment
OMT will be used to treat pregnancy women after having performed a manual osteopathic assessment. The first osteopathic evaluation is carried out during the 12th week, with the possibility to undertake a personalized treatment built on the needs of the single patient; the chosen techniques are based on the collected data by the operator. A "black-box" type of treatment is undertaken.
Usual care
Administration of routine care based on international guidelines
Mindfulness
Mindfulness group weekly meetings. Mindfulness practices consist of cognitive and behavioral treatments for depression and anxiety, including mindfulness-based stress reduction and mindfulness-based cognitive therapy.
Yoga
Weekly yoga group meetings. Yoga is a mind-body practice that encompasses a system of postures, deep breathing, and meditation. In this context, yoga practice is adapted to pregnancy with the aim of benefit women who suffer from anxiety, depression, stress, low back pain, and sleep disturbances.
Clinical nutrition
Nutritional advice to all women participating in the study at 12 weeks of pregnancy, with the possibility of starting an individualized path.
Coaching
There will be five personalized coaching sessions during the pregnancy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Primiparae
* Single pregnancy
* Spontaneous pregnancy - fisiological pregnancy
* pregnancy \>= 12 weeks
* low-back pain (between the 12th rib and the lumbo-pelvic region) and/or pelvic (in the pubic region and/or in one or both of the sacro-iliac joint and/or of the gluteal region) non specific
* consent to treatment
* absence of linguistic barriers
Exclusion Criteria
* Pathological pregnancy, twins
* Metabolic pathologies
* Obstetrician's emergencies
* Pre-term birth
* Specific lumbar and/or pelvic pain - Genetics disorders
* Major congenital anomalies
* Absence of consent to treatment
* Presence of linguistic barriers
18 Years
44 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Come Collaboration
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Niccolò Giovanni, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COME-02-20
Identifier Type: -
Identifier Source: org_study_id