Back to resultsLow-back Pain During Pregnancy and Its Psycho-social Implications
Primary Purpose
Pregnancy Related, Low Back Pain, Pelvic Girdle Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Osteopathic manipulative treatment
Usual care
Mindfulness
Yoga
Clinical nutrition
Coaching
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy Related focused on measuring osteopathic manipulative treatment, pregnancy, pain, low back pain, pelvic girdle pain, psychological factors
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
OMT + multidisciplinary path
Usual care
Arm 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.
Patients in control group will continue the routine obstetrical care as established by international guidelines
Outcomes
Primary Outcome Measures
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
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)
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.
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.
Secondary Outcome Measures
Change in PWB at 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).
Full Information
NCT ID
NCT04682002
First Posted
December 15, 2020
Last Updated
December 20, 2020
Sponsor
Come Collaboration
Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1. Study Identification
Unique Protocol Identification Number
NCT04682002
Brief Title
Low-back Pain During Pregnancy and Its Psycho-social Implications
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2020 (Anticipated)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Come Collaboration
Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Low Back Pain, Pelvic Girdle Pain
Keywords
osteopathic manipulative treatment, pregnancy, pain, low back pain, pelvic girdle pain, psychological factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OMT + multidisciplinary path
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
Other
Arm Description
Patients in control group will continue the routine obstetrical care as established by international guidelines
Intervention Type
Other
Intervention Name(s)
Osteopathic manipulative treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Administration of routine care based on international guidelines
Intervention Type
Other
Intervention Name(s)
Mindfulness
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical nutrition
Intervention Description
Nutritional advice to all women participating in the study at 12 weeks of pregnancy, with the possibility of starting an individualized path.
Intervention Type
Other
Intervention Name(s)
Coaching
Intervention Description
There will be five personalized coaching sessions during the pregnancy.
Primary Outcome Measure Information:
Title
Change in VAS at 6 months
Description
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
Time Frame
6 months
Title
Change in ODI at 6 months
Description
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)
Time Frame
6 months
Title
Change in PMI at 6 months
Description
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.
Time Frame
6 months
Title
Change in PGQ at 6 months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in PWB at 6 months
Description
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).
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Cerritelli, PhD
Phone
+393394332801
Email
francesco.cerritelli@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Manzotti, PT
Phone
+3902 2052 0939
Email
andreamanzotti@soma-osteopatia.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niccolò Giovanni, MD
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
available upon request
Learn more about this trial
Low-back Pain During Pregnancy and Its Psycho-social Implications
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