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

Primary Purpose

Chronic Low Back Pain, Postural Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control. no therapeutic program
Experimental. Therapeutic program
Sponsored by
University of Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring postural control, Chronic Low Back Pain, therapeutic excercise, healed patients

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad de Extremadura

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control. no therapeutic program

Experimental. Therapeutic program

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

weight
Descriptive variable. Its unit of measurement is Kilograms
Height
Descriptive variable. Its unit of measurement is meters
age
Descriptive variable. Its unit of measurement is years
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)
Algometry
Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral)
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
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)
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.
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
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

Full Information

First Posted
August 10, 2018
Last Updated
March 16, 2020
Sponsor
University of Extremadura
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1. Study Identification

Unique Protocol Identification Number
NCT03635242
Brief Title
Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Healed Patients
Official Title
Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Post-treatment Healed Patients by Therapeutic Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 8, 2018 (Actual)
Primary Completion Date
August 8, 2018 (Actual)
Study Completion Date
October 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Extremadura

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
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 .
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 )

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Postural Low Back Pain
Keywords
postural control, Chronic Low Back Pain, therapeutic excercise, healed patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control. no therapeutic program
Arm Type
Active Comparator
Arm Description
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
Arm Title
Experimental. Therapeutic program
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Control. no therapeutic program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Experimental. Therapeutic program
Intervention Description
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
Primary Outcome Measure Information:
Title
pressure platform and accelerometry
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
weight
Description
Descriptive variable. Its unit of measurement is Kilograms
Time Frame
4 weeks
Title
Height
Description
Descriptive variable. Its unit of measurement is meters
Time Frame
4 weeks
Title
age
Description
Descriptive variable. Its unit of measurement is years
Time Frame
4 weeks
Title
EVA (Visual Analog Scale).
Description
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)
Time Frame
4 weeks
Title
Algometry
Description
Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral)
Time Frame
4 weeks
Title
Joint Position Sense (JPS)
Description
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
Time Frame
4 weeks
Title
Roland Morris
Description
determine the degree of disability. The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)
Time Frame
4 weeks
Title
Oswestry Disability Index
Description
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.
Time Frame
4 weeks
Title
Pain Catastrophizing Scale (PCS)
Description
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
Time Frame
4 weeks
Title
The Tampa Kinesiofobia Scale (TSK)
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis LE Espejo-Antúnez, PhD
Organizational Affiliation
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mª Dolores MD Apolo-Arenas, PhD
Organizational Affiliation
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alejandro Caña-Pino, PT,MSc
Organizational Affiliation
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Extremadura
City
Badajoz
ZIP/Postal Code
06071
Country
Spain

12. IPD Sharing Statement

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

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