NCT03324672

Brief Summary

Pregnant women often suffer from lumbar pain , specially during the last semester . Usually physiotherapy and manual therapy on TRIGGER point help them . But there is also another type of support , the Kinesio-Taping using the pose of a strip which aims to mobilize the muscle without any restriction. The purpose is to reduce the pain with the combo therapy (TRIGGER point plus Kinesi Taping)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 24, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

3.5 years

First QC Date

October 25, 2017

Last Update Submit

April 26, 2023

Conditions

Manual Therapy

Keywords

lumbar pain; pregnancy;

Outcome Measures

Primary Outcomes (1)

  • French version of Roland-Morris questionnaire in chronic low back pain patients EIFEL Échelle d'Incapacité Fonctionnelle pour l'Évaluation des Lombalgies questionnaire) score

    EIFEL questionnaire is filled by patient between week 30 of pregnancy to week 38, scale range from 0 to 24,

    change from week 30 to week 38

Secondary Outcomes (1)

  • Pain scale

    change from week 30 to week 38

Study Arms (2)

TRIGGER

ACTIVE COMPARATOR
Procedure: TRIGGER

TRIGGER+CURETAPE

EXPERIMENTAL
Procedure: TRIGGER+CURETAPE

Interventions

TRIGGERPROCEDURE

only TRIGGER point will be included for the manual therapy

TRIGGER
TRIGGER+CURETAPEPROCEDURE

TRIGGER point will be included for the manual therapy with kinesio-taping

TRIGGER+CURETAPE

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly pregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18
  • french speaking
  • single pregnancy
  • lumbar pain
  • EIFEL score\>6
  • medical insurance

You may not qualify if:

  • twins pregnancy
  • rachial arthrodesis
  • Probable Acrylique allergy
  • Psoriasis or other cutaneous problems
  • circulatory disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Precipitating Factors

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • AZRIA Elie, MD

    GHPSJ

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

October 30, 2017

Study Start

July 24, 2019

Primary Completion

January 9, 2023

Study Completion

January 9, 2023

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

FR(1)