Kinesio Taping and Manual Therapy Efficacity on Lumbar Pa... | NCT03324672

Studies
Kinesio Taping and Manual Therapy Efficacity on Lumbar Pain During Pregnancy

NCT03324672

Sponsor

Fondation Hôpital Saint-Joseph

Status

Terminated

Last Update Posted

Apr 28, 2023Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Manual Therapy

Interventions

TRIGGER
TRIGGER+CURETAPE

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI's choice

Expanded Access Info

Start Date

Jul 24, 2019Actual

Primary Completion Date

Jan 9, 2023Actual

Completion Date

Jan 9, 2023Actual

First Submitted Date

Oct 25, 2017

First Submission Date that Met QC Criteria

Oct 26, 2017

First Posted Date

Oct 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2023

Last Update Posted Date

Apr 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TRIGGER	Active Comparator		Procedure: TRIGGER
TRIGGER+CURETAPE	Experimental		Procedure: TRIGGER+CURETAPE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TRIGGER	Procedure	only TRIGGER point will be included for the manual therapy	TRIGGER

Outcomes Module

Primary Outcomes

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	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

Measure	Description	Time Frame
Pain scale	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

only pregnant women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AZRIA Elie, MD	GHPSJ	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015985	Precipitating Factors

Ancestor Terms

ID	Term
D015984	Causality
D015981	Epidemiologic Factors
D011787	Quality of Health Care
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided