NCT03849053

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable low-back-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

February 19, 2019

Last Update Submit

March 17, 2019

Conditions

Keywords

Low back painMézières methodPostural treatmentAthletes

Outcome Measures

Primary Outcomes (3)

  • 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.

    6 months

  • 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.

    6 months

  • 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).

    6 months

Secondary Outcomes (2)

  • Roland-Morris Questionnaire (CRM)

    6 months

  • Health status questionnaire (SF-12)

    6 months

Study Arms (2)

Mézières method

EXPERIMENTAL
Other: Mézières Therapy for Low back pain

Control Group

ACTIVE COMPARATOR
Other: Mézières Therapy for Low back pain

Interventions

Spinal muscular global stretching

Control GroupMézières method

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • between 15 - 39 years
  • athletes with low back pain lasting more than 1 month
  • scoliosis
  • kyphosis

You may not qualify if:

  • presence of tumors or spinal metastases
  • vertebral fractures
  • osteoporosis
  • infection or inflammation in acute diseases with involvement of the central nervous system
  • herniated discs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back PainSprains and Strains

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 21, 2019

Study Start

December 1, 2016

Primary Completion

June 30, 2017

Study Completion

May 20, 2018

Last Updated

March 19, 2019

Record last verified: 2019-03