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NCT Number: NCT03635242

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

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 .

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Key information

Conditions

Chronic Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Postural Low Back Pain Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Extremadura

Badajoz, 06071, Spain

About this study

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 )

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control. no therapeutic program

Other

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. Therapeutic program

Other

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 outcomes

  1. pressure platform and accelerometry

    Time frame: 4 weeks

    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 outcomes

  1. weight

    Time frame: 4 weeks

    Descriptive variable. Its unit of measurement is Kilograms

  2. Height

    Time frame: 4 weeks

    Descriptive variable. Its unit of measurement is meters

  3. age

    Time frame: 4 weeks

    Descriptive variable. Its unit of measurement is years

  4. EVA (Visual Analog Scale).

    Time frame: 4 weeks

    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)

  5. Algometry

    Time frame: 4 weeks

    Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral)

  6. Joint Position Sense (JPS)

    Time frame: 4 weeks

    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

  7. Roland Morris

    Time frame: 4 weeks

    determine the degree of disability. The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)

  8. Oswestry Disability Index

    Time frame: 4 weeks

    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.

  9. Pain Catastrophizing Scale (PCS)

    Time frame: 4 weeks

    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

  10. The Tampa Kinesiofobia Scale (TSK)

    Time frame: 4 weeks

    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

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2018
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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