NCT03635242

Brief Summary

Pretending with the use of accelerometers and pressure platform, determine indicators that are useful to therapists to assess postural control and balance, to subsequently allow to evaluate the effect of therapeutic interventions through therapeutic exercise of motor control in patients with chronic low back pain .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

June 8, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2018

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

August 10, 2018

Last Update Submit

March 16, 2020

Conditions

Chronic Low Back PainPostural Low Back Pain

Keywords

postural controlChronic Low Back Paintherapeutic excercisehealed patients

Outcome Measures

Primary Outcomes (1)

  • pressure platform and accelerometry

    Stay for 30 seconds each test on a pressure platform. Accelerometer in the pelvis (center of mass), fixed by velcro tape. Application of the Romberg test. (Standing with open eyes and closed on stable and unstable surface).The unit of the accelerometer is mg (1 mg = 0.001) and the kinetic energy of the signal is measured in Julians x 10-6 The displacement unit of the pressure center of the platform is millimeters

    4 weeks

Secondary Outcomes (10)

  • weight

    4 weeks

  • Height

    4 weeks

  • age

    4 weeks

  • EVA (Visual Analog Scale).

    4 weeks

  • Algometry

    4 weeks

  • +5 more secondary outcomes

Study Arms (2)

Control. no therapeutic program

ACTIVE COMPARATOR

The control group continued to perform their daily activities without changing any habit. Group of healthy subjects Assessment of postural control through accelerometry and pressure platform

Other: Control. no therapeutic program

Experimental. Therapeutic program

EXPERIMENTAL

People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months. Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform

Other: Experimental. Therapeutic program

Interventions

Control. no therapeutic programOTHER

The control group continued to perform their daily activities without changing any habit. Group of healthy subjects Assessment of postural control through accelerometry and pressure platform

Control. no therapeutic program
Experimental. Therapeutic programOTHER

People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months. Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform

Experimental. Therapeutic program

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • low back pain with painful perception on a daily or almost daily basis for more than three months of clinical course, with or without pain radiating to the lower extremities above the knee.
  • not having metal implants in the spine
  • own ability to read and write
  • and access the study voluntarily.

You may not qualify if:

  • vestibular disorders
  • without severe visual impairment
  • no medication intake with a potential effect on balance during the 90 days prior to data collection
  • physiotherapy treatment 2 weeks before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Extremadura

Badajoz, 06071, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luis LE Espejo-Antúnez, PhD

    Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain

    STUDY DIRECTOR

  • Mª Dolores MD Apolo-Arenas, PhD

    Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain

    STUDY DIRECTOR

  • Alejandro Caña-Pino, PT,MSc

    Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Surgical-Therapy Department, Universidad de Extremadura Facultad de Medicina, Badajoz, Spain

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 17, 2018

Study Start

June 8, 2018

Primary Completion

August 8, 2018

Study Completion

October 9, 2018

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations

ES(1)