Pregnancy RelatedNCT04682002
Low-back Pain During Pregnancy and Its Psycho-social Implications
A study testing Osteopathic manipulative treatment, Mindfulness and Yoga in people with Pregnancy Related and Low Back Pain, run by Come Collaboration.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Low Back Pain, Pelvic Girdle Pain
- What is being tested?
- Osteopathic manipulative treatment, Mindfulness and Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Women aged <18 o >44
- Pathological pregnancy, twins
- Metabolic pathologies
- Obstetrician's emergencies
- Pre-term birth
- Specific lumbar and/or pelvic pain - Genetics disorders
Show all 9Show fewer
- Major congenital anomalies
- Absence of consent to treatment
- Presence of linguistic barriers
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- Osteopathic manipulative treatment, Usual care, Mindfulness, Yoga, Clinical nutrition
- Keywords
- osteopathic manipulative treatment, pregnancy, pain, low back pain, pelvic girdle pain, psychological factors
- Medical subject headings
- Low Back Pain, Pelvic Girdle Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative treatmentOther
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.
Usual careOther
Administration of routine care based on international guidelines
MindfulnessOther
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.
YogaOther
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.
Clinical nutritionOther
Nutritional advice to all women participating in the study at 12 weeks of pregnancy, with the possibility of starting an individualized path.
CoachingOther
There will be five personalized coaching sessions during the pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start15 Dec 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Come Collaboration
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niccolò Giovanni, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682002
- Sponsor's protocol ID
- COME-02-20
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: available upon request
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04682002
- Acronym / sponsor ID
- COME-02-20
- Conditions
- Pregnancy Related, Low Back Pain, Pelvic Girdle Pain
- Keywords
- osteopathic manipulative treatment, pregnancy, pain, low back pain, pelvic girdle pain, psychological factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Come CollaborationUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMT + multidisciplinary path | Experimental | Other: Osteopathic manipulative treatment, Other: Mindfulness, Other: Yoga, Other: Clinical nutrition, Other: CoachingPatients 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. |
| Usual care | Other | Other: Usual carePatients in control group will continue the routine obstetrical care as established by international guidelines |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women aged 18-44
- Primiparae
- Single pregnancy
- Spontaneous pregnancy - fisiological pregnancy
- pregnancy >= 12 weeks
Key exclusion criteria (9 listed)
- Women aged <18 o >44
- Pathological pregnancy, twins
- Metabolic pathologies
- Obstetrician's emergencies
- Pre-term birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic manipulative treatmentOMT 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 | OMT + multidisciplinary path |
| Usual careAdministration of routine care based on international guidelines | Other | Usual care |
| MindfulnessMindfulness 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 | OMT + multidisciplinary path |
| YogaWeekly 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 | OMT + multidisciplinary path |
| Clinical nutritionNutritional advice to all women participating in the study at 12 weeks of pregnancy, with the possibility of starting an individualized path. | Other | OMT + multidisciplinary path |
| CoachingThere will be five personalized coaching sessions during the pregnancy. | Other | OMT + multidisciplinary path |
Primary outcome
Change in VAS at 6 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Change in PWB at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Individual participant dataSharing planned: No. available upon request
Related trials for Pregnancy Related
Not yet recruitingPhase 1
DV Plus Toripalimab With Cetirizine and Mecobalamin Pretreatment in Patients With Locally Advanced Unresectable or Metastatic Bladder Cancer
Bladder Cancer
RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
Not yet recruitingObservational study
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Cardiac Abnormalities, Nutrient Intake
RecruitingObservational study
Immune System Related Kidney Disease
Kidney Disease, Nephrotic Syndrome
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niccolò Giovanni, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manipulative treatment, Mindfulness and Yoga in people with Pregnancy Related and Low Back Pain, run by Come Collaboration.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Cerritelli, PhD (+393394332801, francesco.cerritelli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VAS at 6 months (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.