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

NCT04682002 | Unknown DMC

• 1 other identifier: COME-02-20
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

osteopathic manipulative treatment; pregnancy; pain; low back pain; pelvic girdle pain; psychological factors

Outcome Measures

Primary Outcomes (4)

• Change in VAS at 6 months

  Change from Visual Analogue Scale (VAS) of pain at 6 months. VAS values range from 0-10, where 10 means highest pain and 0 no pain

  6 months

• Change in ODI at 6 months

  Change from Oswestry disability index 2.1° - Italian version (ODI) of the score at 6 months. The ODI represents a ten 6-point questionnaire. The first section rates the intensity of pain and the remaining ones cover the disabling effect of pain on typical daily activities: personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each item ranges from 0 to 5 and the sum of the 10 scores is expressed as a percentage of the maximum scores, varying from 0 (no disability) to 100 (maximum disability)

  6 months

• Change in PMI at 6 months

  Change from Pregnancy mobility index (PMI) of the score at 6 months. PMI is a self-report questionnaire to assess mobility in relation to back and pelvic girdle pain. The PMI consists of three scales: daily mobility in the house, household activities and mobility outdoors. Every item has a score option from 0-3 (respectively 'no problems performing this task', 'some effort performing this task', 'much effort performing this task', 'performing this task is impossible or only possible with the aid of others'), which was transformed to a 0-100 scale. Each domain score is the mean of all included items.

  6 months

• Change in PGQ at 6 months

  Change from Pelvic-girdle pain questionnaire (PGQ) of the score at 6 months. The PGQ is a condition-specific, patient-reported outcome measure designed to measure pregnancy-related back pain and pelvic girdle pain for use both during pregnancy and postpartum in research and clinical practice. The questionnaire includes items relating to 2 scales (activity/ participation and body functions \[symptoms\]). Self-report questionnaire of 20 activity items and 5 symptom items scored on a 4-point response scale. Each question is scored from 'Not at all' (0) to 'To a large extent' (3). Questions on the activity sub-scale range from difficulty with dressing, climbing stairs, doing housework, rolling in bed to pushing a shopping cart. Item scores are summed and transformed to yield a score of 0 to 100, where 100 is the worst possible score.

  6 months

Secondary Outcomes (1)

• Change in PWB at 6 months

  6 months

Study Arms (2)

OMT + multidisciplinary path

EXPERIMENTAL

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.

Other: Osteopathic manipulative treatment; Other: Mindfulness; Other: Yoga; Other: Clinical nutrition; Other: Coaching

Usual care

OTHER

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

Other: Usual care

Interventions

Osteopathic manipulative treatment OTHER

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.

OMT + multidisciplinary path

Usual care OTHER

Administration of routine care based on international guidelines

Usual care

Mindfulness OTHER

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.

OMT + multidisciplinary path

Yoga OTHER

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.

OMT + multidisciplinary path

Clinical nutrition OTHER

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

OMT + multidisciplinary path

Coaching OTHER

There will be five personalized coaching sessions during the pregnancy.

OMT + multidisciplinary path

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Come Collaboration: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

MeSH Terms

Conditions

Low Back Pain; Pelvic Girdle Pain; Pain

Interventions

Manipulation, Osteopathic; Mindfulness; Yoga

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Pain; Pelvic Pain

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Spiritual Therapies; Exercise Movement Techniques

Study Officials

• Niccolò Giovanni, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Cerritelli, PhD

CONTACT

+393394332801; francesco.cerritelli@gmail.com

Andrea Manzotti, PT

CONTACT

+3902 2052 0939; andreamanzotti@soma-osteopatia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 23, 2020
• Study Start: December 15, 2020
• Primary Completion: February 28, 2021
• Study Completion: August 30, 2021
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share