Low Back PainLomboMat2021NCT05072002
Treatment of Low Back Pain in Pregnant Women : Uses of Drugs and Other Therapies
An observational study of Low Back Pain and Pregnancy Related, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Low back pain is a frequent clinical condition in pregnancy. Drugs treatments are limited. Other therapies are often used, associated or not with drugs (acupuncture, manipulative medicine, physical therapies, homeopathy). Clinical studies suggest a reduction of low back pain with these therapies. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Pregnancy Related
- How many people
- 370 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2021to 30 Apr 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women in Lorraine
Who may be able to join
- pregnant women
Who cannot join
- medical history of : bifida spina, discal hernia, osteoporosis, vertebral compaction, spondylolisthesis, scoliosis ( over 30°)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Low Back Pain in Pregnant Women ; Uses of Drugs and Other Therapies (Acupuncture, Manipulative Medicine, Physical Therapies, Homeopathy) : an Observational Study
Low back pain is a frequent clinical condition in pregnancy. Drugs treatments are limited. Other therapies are often used, associated or not with drugs (acupuncture, manipulative medicine, physical therapies, homeopathy). Clinical studies suggest a reduction of low back pain with these therapies.
The primary objective of this study is to determinate how many pregnant women use these alternative therapeutics.
In a second time, we want evaluate efficiency of these therapeutics, especially in pain modification and on quality of life.
Our study is a declarative study on pregnant women in Lorraine.
- Conditions
- Low Back Pain, Pregnancy Related
- Being tested
- no intervention / observational study
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention / observational studyOther
no intervention / observational study
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with low back pain | Not described Receives: Other: no intervention / observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of use of other therapies in pregnant women with low back pain ( acunpucture, manipulative medicine, physical therapies, homeopathy)
Measured: one day : when each pregnant women submit the questionnaire
Secondary outcomes (2)
Difference of visual analog scale for pain after and before treatment
Measured: one day : when each pregnant women submit the questionnaire
Difference of quality life scale after and before treatment
Including : affect, walking, sleep, work, social relations. Scale between 0 and 10 for each item
Measured: one day : when each pregnant women submit the questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start15 Feb 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 370 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis Guillemin, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072002
- Sponsor's protocol ID
- 2020PI113
- Acronym
- LomboMat2021
- Status last verified
- Jan 2021
- First submitted
- 1 Oct 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Low Back Pain in Pregnant Women ; Uses of Drugs and Other Therapies (Acupuncture, Manipulative Medicine, Physical Therapies, Homeopathy) : an Observational Study
- ClinicalTrials.gov ID
- NCT05072002
- Acronym / sponsor ID
- LomboMat2021 / 2020PI113
- Conditions
- Low Back Pain, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 8 Oct 2021 (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.
Low back pain is a frequent clinical condition in pregnancy. Drugs treatments are limited. Other therapies are often used, associated or not with drugs (acupuncture, manipulative medicine, physical therapies, homeopathy). Clinical studies suggest a reduction of low back pain with these therapies.
The primary objective of this study is to determinate how many pregnant women use these alternative therapeutics.
In a second time, we want evaluate efficiency of these therapeutics, especially in pain modification and on quality of life.
Our study is a declarative study on pregnant women in Lorraine.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women with low back pain | – | Other: no intervention / observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women in Lorraine
Key inclusion criteria (1 listed)
- pregnant women
Key exclusion criteria (1 listed)
- medical history of : bifida spina, discal hernia, osteoporosis, vertebral compaction, spondylolisthesis, scoliosis ( over 30°)
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 |
|---|---|---|
| no intervention / observational studyno intervention / observational study | Other | pregnant women with low back pain |
Primary outcome
Percentage of use of other therapies in pregnant women with low back pain ( acunpucture, manipulative medicine, physical therapies, homeopathy)
Time frame: one day : when each pregnant women submit the questionnaire
2 secondary outcomes
Difference of visual analog scale for pain after and before treatment
Time frame: one day : when each pregnant women submit the questionnaire
Difference of quality life scale after and before treatment
Time frame: one day : when each pregnant women submit the questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Francis Guillemin principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Pregnancy Related, run by Central Hospital, Nancy, France at 1 site in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of use of other therapies in pregnant women with low back pain ( acunpucture, manipulative medicine, physical therapies, homeopathy) (time frame: one day : when each pregnant women submit the questionnaire). 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 8 Oct 2021.