Kinesio Taping and Manual Therapy Efficacity on Lumbar Pain During Pregnancy

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe hospitalier Paris saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TRIGGER
Procedure: TRIGGER
only TRIGGER point will be included for the manual therapy
Experimental: TRIGGER+CURETAPE
Procedure: TRIGGER+CURETAPE
TRIGGER point will be included for the manual therapy with kinesio-taping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
French version of Roland-Morris questionnaire in chronic low back pain patients EIFEL Échelle d'Incapacité Fonctionnelle pour l'Évaluation des Lombalgies questionnaire) score
Time Frame: change from week 30 to week 38
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scale
Time Frame: change from week 30 to week 38
Pain scale is filled by patient between week 30 of pregnancay to week 30, scale range from 0 to 10
change from week 30 to week 38

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Study Director: AZRIA Elie, MD, GHPSJ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2019

Primary Completion (Actual)

January 9, 2023

Study Completion (Actual)

January 9, 2023

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (Actual)

October 30, 2017

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIGGER

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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