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

Come Collaboration

Status: Unknown

Conditions: Pregnancy Related; Pelvic Girdle Pain; Low Back Pain

Treatments: Other: Coaching; Other: Clinical nutrition; Other: Mindfulness; Other: Yoga; Other: Osteopathic manipulative treatment; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04682002

COME-02-20

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged 18-44
• 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

• Women aged <18 o >44
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

OMT + multidisciplinary path

Experimental group

Description:

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.

Treatment:

Other: Clinical nutrition

Other: Mindfulness

Other: Yoga

Other: Coaching

Other: Osteopathic manipulative treatment

Usual care

Other group

Description:

Patients in control group will continue the routine obstetrical care as established by international guidelines

Treatment:

Other: Usual care