Mézières Therapy in the UCAM's Athletes With Low Back Pain
Primary Purpose
Low Back Pain, Postural; Strain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mézières Therapy for Low back pain
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Mézières method, Postural treatment, Athletes
Eligibility Criteria
Inclusion Criteria:
- between 15 - 39 years
- athletes with low back pain lasting more than 1 month
- scoliosis
- kyphosis
Exclusion Criteria:
- presence of tumors or spinal metastases
- vertebral fractures
- osteoporosis
- infection or inflammation in acute diseases with involvement of the central nervous system
- herniated discs
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mézières method
Control Group
Arm Description
Outcomes
Primary Outcome Measures
VAS (Visual Analogic Scale)
It consists in identifying the patient, on a 10 cm line, the point that best represents his pain, where 0 means no pain and 10 = worst possible pain.
Sit and Reach flexibility test
Designed to test the flexibility of lower back and hamstring muscles and is important as a result of lumbar lordosis, forward pelvic tilt and lower back pain. The score is recorded to the nearest inch/cm or inch/cm as the distance reached by the hand. For women, the lowest value is ˂ -15 cm and the highest is ˃ +30 cm. For men instead, the lowest value is ˂ -20 cm and the highest is >+27 cm.
Runtastic Performance Pedometer
- Runtastic PRO is an app aimed at recording fitness in many activities and sports. It captures all basic data: distance, average speed, speed between mile markers, altitude, pace, step between mile markers, duration, calories burned and route plotted on a map using Global Positioning System. The final result shows how many steps are made in the arc of the minute (st / 60sec).
Secondary Outcome Measures
Roland-Morris Questionnaire (CRM)
Measures the physical disability of athletes and consists of 24 points of functional capacity of the back. The sense of progression is: the more serious the worse is the performance.
Health status questionnaire (SF-12)
The questionnaire consists in 12 items of the 8 dimensions of the SF-36 (124) such as: physical function (2), social function (1), physical role (2), emotional role (2), mental health (2), vitality (1), body pain (1), general health (1). Meanwhile response options forms Likert-type scales that evaluate intensity or frequency are achieved.
Full Information
NCT ID
NCT03849053
First Posted
February 19, 2019
Last Updated
March 17, 2019
Sponsor
Universidad Católica San Antonio de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT03849053
Brief Title
Mézières Therapy in the UCAM's Athletes With Low Back Pain
Official Title
The Effectiveness of Mézières Therapy in the UCAM's Athletes With Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
May 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
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
The purpose of this research study focuses on the re-harmonization of the kinetic chains and posture based on spinal muscular atrophy and global stretching while trying to test the effectiveness of Mézières therapy on sports subjects with low back pain.
Detailed Description
The experimental study was conducted on 139 young athletes of National Rhythmic Gymnastics of Murcia, UCAM Murcia CF and UCAM Murcia CB/EBA during a six months period in the city of Murcia. Precisely, the Mézières therapy was conducted in an experimental group of 69 athletes and in a control group with other 70 athletes with Low Back Pain. This study is developed through a cycle of global stretching decompensate interventions on the athletes with postural alterations and vertebral pain at 95% confidence level. The statistical analysis was handled by using the univariate general linear model with the support of SPSS statistics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Postural; Strain
Keywords
Low back pain, Mézières method, Postural treatment, Athletes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mézières method
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Mézières Therapy for Low back pain
Intervention Description
Spinal muscular global stretching
Primary Outcome Measure Information:
Title
VAS (Visual Analogic Scale)
Description
It consists in identifying the patient, on a 10 cm line, the point that best represents his pain, where 0 means no pain and 10 = worst possible pain.
Time Frame
6 months
Title
Sit and Reach flexibility test
Description
Designed to test the flexibility of lower back and hamstring muscles and is important as a result of lumbar lordosis, forward pelvic tilt and lower back pain. The score is recorded to the nearest inch/cm or inch/cm as the distance reached by the hand. For women, the lowest value is ˂ -15 cm and the highest is ˃ +30 cm. For men instead, the lowest value is ˂ -20 cm and the highest is >+27 cm.
Time Frame
6 months
Title
Runtastic Performance Pedometer
Description
- Runtastic PRO is an app aimed at recording fitness in many activities and sports. It captures all basic data: distance, average speed, speed between mile markers, altitude, pace, step between mile markers, duration, calories burned and route plotted on a map using Global Positioning System. The final result shows how many steps are made in the arc of the minute (st / 60sec).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Roland-Morris Questionnaire (CRM)
Description
Measures the physical disability of athletes and consists of 24 points of functional capacity of the back. The sense of progression is: the more serious the worse is the performance.
Time Frame
6 months
Title
Health status questionnaire (SF-12)
Description
The questionnaire consists in 12 items of the 8 dimensions of the SF-36 (124) such as: physical function (2), social function (1), physical role (2), emotional role (2), mental health (2), vitality (1), body pain (1), general health (1). Meanwhile response options forms Likert-type scales that evaluate intensity or frequency are achieved.
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
between 15 - 39 years
athletes with low back pain lasting more than 1 month
scoliosis
kyphosis
Exclusion Criteria:
presence of tumors or spinal metastases
vertebral fractures
osteoporosis
infection or inflammation in acute diseases with involvement of the central nervous system
herniated discs
12. IPD Sharing Statement
Learn more about this trial
Mézières Therapy in the UCAM's Athletes With Low Back Pain
We'll reach out to this number within 24 hrs