Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Healed Patients

Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Post-treatment Healed Patients by Therapeutic Exercise

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 .

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain; Postural Low Back Pain
• Intervention / Treatment: Other: Control. no therapeutic program; Other: Experimental. Therapeutic program

Detailed Description

The records are made simultaneously with the different evaluation equipment, accelerometer and pressure platform. The tests are performed in a control group of healthy subjects, and in an experimental group with DLC receiving a program of therapeutic exercise based and pain education based on neuroscience.

After the collection of the records, the behavior patterns in both groups are evaluated, the possible differences among them are established for the clinimetric indicators analyzed related to the postural control, as well as a characteristic of the sample.

Subsequently, through the evaluation after the intervention of the experimental group we will analyze the effect of a physiotherapy treatment based on the therapeutic exercise of motor control on parameters related to postural control and clinical variables (perceived pain, mechanosensitivity, disability and proprioceptive repositioning of the lumbar spine )

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain, 06071
    • Universidad de Extremadura

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control. no therapeutic program; 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; 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
Experimental: Experimental. Therapeutic program; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	Descriptive variable. Its unit of measurement is Kilograms	4 weeks
Height	Descriptive variable. Its unit of measurement is meters	4 weeks
age	Descriptive variable. Its unit of measurement is years	4 weeks
EVA (Visual Analog Scale).	Used for pain assessment in an analogical way, that is, by means of a line of 10 centimeters. 0 (absence of pain); 10 (maximum pain)	4 weeks
Algometry	Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral)	4 weeks
Joint Position Sense (JPS)	Joint Position Sense (JPS) to evaluate the proprioceptive joint positioning of the lumbar spine with a digital goniometer at 30º flexion in standing and sitting	4 weeks
Roland Morris	determine the degree of disability. The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)	4 weeks
Oswestry Disability Index	The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability Scoring instructions For each section of the total possible score is 5: if the first statement is mark ed the section score = 0; if the last statement is marked, it = 5.	4 weeks
Pain Catastrophizing Scale (PCS)	it measures the catastrophic thoughts before the pain, that is, the negative thought before the pain. In the PCS, people take the painful past experience as a reference and indicate the degree to which they experience certain thoughts and feelings. The PCS is composed of 13 items, on a Likert scale of 5 points that goes from 0 (never) to 4 (always). Higher scores indicate higher levels of catastrophism	4 weeks
The Tampa Kinesiofobia Scale (TSK)	It is commonly used in clinical practice to quantify pain levels related to fear of activity or to a new injury in patients with back pain. Patients with high levels of kinesiofobia are often considered at greater risk of developing long-term activity limitation and chronicity	4 weeks

Collaborators and Investigators

• Sponsor: University of Extremadura
• Investigators: Study Director: Mª Dolores MD Apolo-Arenas, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain; Study Director: Luis LE Espejo-Antúnez, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain; Principal Investigator: Alejandro Caña-Pino, PT,MSc, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2018
• Primary Completion (Actual): August 8, 2018
• Study Completion (Actual): October 9, 2018

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Chronic Low Back Pain; postural control; therapeutic excercise; healed patients
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 08062018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No