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NCT05072002 Clinical Trial

Treatment of Low Back Pain in Pregnant Women : Uses of Drugs and Other Therapies

Low Back Pain Clinical Trial

— LomboMat2021  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05072002
Other study ID # 2020PI113
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2021
Est. completion date April 30, 2021

Study information
Verified date January 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 370
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - pregnant women Exclusion Criteria: - medical history of : bifida spina, discal hernia, osteoporosis, vertebral compaction, spondylolisthesis, scoliosis ( over 30°)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention / observational study
no intervention / observational study

Locations
Country Name City State
France Centre hospitalier régional universitaire de Nancy Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of use of other therapies in pregnant women with low back pain ( acunpucture, manipulative medicine, physical therapies, homeopathy) one day : when each pregnant women submit the questionnaire
Secondary Difference of visual analog scale for pain after and before treatment one day : when each pregnant women submit the questionnaire
Secondary Difference of quality life scale after and before treatment Including : affect, walking, sleep, work, social relations. Scale between 0 and 10 for each item one day : when each pregnant women submit the questionnaire
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