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

Sponsor

Come Collaboration (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04682002

Collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)

Enrollment

Arms

8.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Low Back Pain Pelvic Girdle Pain	Other: Osteopathic manipulative treatment Other: Usual care Other: Mindfulness Other: Yoga Other: Clinical nutrition Other: Coaching	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 15, 2020

Anticipated Primary Completion Date :

Feb 28, 2021

Anticipated Study Completion Date :

Aug 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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: 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.
Other: Usual care Patients in control group will continue the routine obstetrical care as established by international guidelines	Other: Usual care Administration of routine care based on international guidelines

Arm

Intervention/Treatment

Experimental: 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.

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: 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.

Other: Usual care

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

Other: Usual care

Administration of routine care based on international guidelines

Outcome Measures

Primary Outcome Measures

Change in VAS at 6 months [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
Change in ODI at 6 months [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)
Change in PMI at 6 months [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.
Change in PGQ at 6 months [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.

Secondary Outcome Measures

Change in PWB at 6 months [6 months]
Change from Ryff's Psychological Well-Being Scales (PWB) of the score at 6 months. Ryff, the 42-item Psychological Wellbeing (PWB) Scale measures six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Respondents rate how strongly they agree or disagree with 42 statements using a 7-point scale (1 = strongly agree; 7 = strongly disagree).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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