Kinesio Taping and Manual Therapy Efficacity on Lumbar Pain During Pregnancy

• Sponsor: Groupe Hospitalier Paris Saint Joseph (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03324672
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 41.3
• Patients Per Site Per Month: 1.4

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Manual Therapy	Procedure: TRIGGER; Procedure: TRIGGER+CURETAPE	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Kinesio Taping and Manual Therapy Efficacity on Lumbar Pain During Pregnancy
• Actual Study Start Date: Jul 24, 2019
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [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,

Secondary Outcome Measures

1. Pain scale [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France	France	75014

Sponsors and Collaborators

• Groupe Hospitalier Paris Saint Joseph

Investigators

• Study Director: AZRIA Elie, MD, GHPSJ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Groupe Hospitalier Paris Saint Joseph
• ClinicalTrials.gov Identifier: NCT03324672
• Other Study ID Numbers: TRIGGER
• First Posted: Oct 30, 2017
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Groupe Hospitalier Paris Saint Joseph: lumbar pain; pregnancy;
• Additional relevant MeSH terms: Low Back Pain

Study Results

No Results Posted as of Mar 31, 2022