Low-back Pain During Pregnancy and Its Psycho-social Implications

Summary

Pregnancy-related pelvic girdle pain (PPP) and pregnancy-related lumbar pain (PLBP) are two distinct symptoms, which can occur together as lumbar-pelvic pain.The primary objective is to measure the impact of osteopathic manipulative treatment on pregnancy-related lumbar and pelvic pain. The secondary objective is to study the interaction between pain and psycho-social factors during the gestational period.

Conditions

• Pregnancy Related
• Low Back Pain
• Pelvic Girdle Pain

Interventions

OTHER

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.

OTHER

Usual care

Administration of routine care based on international guidelines

OTHER

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.

OTHER

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.

OTHER

Clinical nutrition

Nutritional advice to all women participating in the study at 12 weeks of pregnancy, with the possibility of starting an individualized path.

OTHER

Coaching

There will be five personalized coaching sessions during the pregnancy.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Come Collaboration

  lead OTHER

Principal Investigators

• Niccolò Giovanni, MD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

44 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-15

Primary Completion

2021-02-28

Completion

2021-08-30