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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03635242
Other study ID # 08062018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 8, 2018
Est. completion date October 9, 2018

Study information

Verified date March 2020
Source University of Extremadura
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


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 )


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 9, 2018
Est. primary completion date August 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

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. 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

Locations

Country Name City State
Spain Universidad de Extremadura Badajoz

Sponsors (1)

Lead Sponsor Collaborator
University of Extremadura

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 weight Descriptive variable. Its unit of measurement is Kilograms 4 weeks
Secondary Height Descriptive variable. Its unit of measurement is meters 4 weeks
Secondary age Descriptive variable. Its unit of measurement is years 4 weeks
Secondary 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
Secondary Algometry Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral) 4 weeks
Secondary Joint Position Sense (JPS) Joint Position Sense (JPS) to evaluate the proprioceptive joint positioning of the lumbar spine with a digital goniometer at 30ยบ flexion in standing and sitting 4 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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