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Kinesio Taping and Manual Therapy Efficacity on Lumbar Pain During Pregnancy

Primary Purpose

Manual Therapy

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TRIGGER
TRIGGER+CURETAPE
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Manual Therapy focused on measuring lumbar pain; pregnancy;

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Groupe Hospitalier Paris Saint Joseph

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TRIGGER

TRIGGER+CURETAPE

Arm Description

Outcomes

Primary Outcome Measures

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,

Secondary Outcome Measures

Pain scale
Pain scale is filled by patient between week 30 of pregnancay to week 30, scale range from 0 to 10

Full Information

First Posted
October 25, 2017
Last Updated
April 26, 2023
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT03324672
Brief Title
Kinesio Taping and Manual Therapy Efficacity on Lumbar Pain During Pregnancy
Official Title
Kinesio Taping and Manual Therapy Efficacity on Lumbar Pain During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
PI's choice
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
January 9, 2023 (Actual)
Study Completion Date
January 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Manual Therapy
Keywords
lumbar pain; pregnancy;

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRIGGER
Arm Type
Active Comparator
Arm Title
TRIGGER+CURETAPE
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
TRIGGER
Intervention Description
only TRIGGER point will be included for the manual therapy
Intervention Type
Procedure
Intervention Name(s)
TRIGGER+CURETAPE
Intervention Description
TRIGGER point will be included for the manual therapy with kinesio-taping
Primary Outcome Measure Information:
Title
French version of Roland-Morris questionnaire in chronic low back pain patients EIFEL Échelle d'Incapacité Fonctionnelle pour l'Évaluation des Lombalgies questionnaire) score
Description
EIFEL questionnaire is filled by patient between week 30 of pregnancy to week 38, scale range from 0 to 24,
Time Frame
change from week 30 to week 38
Secondary Outcome Measure Information:
Title
Pain scale
Description
Pain scale is filled by patient between week 30 of pregnancay to week 30, scale range from 0 to 10
Time Frame
change from week 30 to week 38

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
only pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 18 french speaking single pregnancy lumbar pain EIFEL score>6 medical insurance Exclusion Criteria: twins pregnancy rachial arthrodesis Probable Acrylique allergy Psoriasis or other cutaneous problems circulatory disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AZRIA Elie, MD
Organizational Affiliation
GHPSJ
Official's Role
Study Director
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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Kinesio Taping and Manual Therapy Efficacity on Lumbar Pain During Pregnancy

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