NCT04682002

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

Low-back Pain During Pregnancy and Its Psycho-social Implications. The Role of the Osteopathic Manipulative Treatment Within Its Multi-disciplinary Management. A Randomised Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Come Collaboration · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-12-15
• Primary completion: 2021-02-28
• Completion: 2021-08-30
• First posted: 2020-12-23
• Last updated: 2020-12-23