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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05149703
Other study ID # CE102105
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 14, 2022
Est. completion date July 30, 2022

Study information

Verified date November 2022
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: Low back pain is a musculoskeletal disorder that is associated with symptoms such as pain, limitation of joint range and postural problems in athletes. Methods: The study design is a randomized controlled clinical trial with a minimum of 35 elite gymnasts with back pain. Two postural treatments will be implemented, Mezieres Method and Isostretching to verify if there is improvement of back pain in gymnasts and to compare both procedures. Discussion: This trial could generate a greater understanding of the importance of posture related to low back pain and its possible treatments.


Description:

A randomized controlled clinical trial with two groups (intervention and placebo) will be implemented. The intervention group will have the Mezieres technique as postural treatment while the placebo group will follow a total of 6 isostretching positions. In total, the two treatments with 30 minutes and duration or with a frequency of 2 weekly sessions will be implemented for a period of 12 weeks. All treatments will be performed by the same certified therapist and with a minimum of 5 years of experience in postural treatments. The measurements will be made immediately after the first session, in 2 weeks, 6 weeks and in the last week of intervention by a blind researcher who did not participate in the treatments, but with experience in this field.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 30, 2022
Est. primary completion date June 16, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 30 Years
Eligibility Inclusion Criteria: - Elite gymnastic athletes with low back pain - Active participation in the national competition - Practice at least three times a week for 60 minutes - Minimum training time of 7 hours a week Exclusion Criteria: - Gymnast whom suffer from chronic disease or acute musculoskeletal injury - Herniated disc - Spondylolisthesis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mezieres Postural Treatment
Implementation of 12 weeks suitable postures of Mezieres method

Locations

Country Name City State
Spain Universidad Católica de Murcia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Back status Measured with Oswestry questionaire. It consists of 10 categories. Each category consists of 6 items scored from 0 to 5 with the first statement scoring 0 until the last statement scoring 5. 12 weeks
Primary Back disability Measured with Roland Morris Questionaire wich consist in 24 points of back disability actual phrases 12 weeks
Primary Range of motion Measured with Baiobit software 12 weeks
Primary Pain intensity Measured with Numeric Rating Scale wich consist in measure pain intensity with a score of 0-10 12 weeks
Secondary Subjetive tension perception Measured with Borg Scale, which include a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort. 12 weeks
Secondary Spinal curvature evaluation Measured with Spinal Mouse Software 12 weeks
Secondary Stiffness test Measured with Baiobit software 12 weeks
Secondary Posture stability Measured with stabilometry with a duration of 50 seconds with Lizard posturometric and stabilometric platform 12 weeks
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