Skip to main content
OpenTrials
Completed

NCT Number: NCT04685837

New Technologies in the Management of Lumbopelvic Pain

Lumbopelvic pain represents one of the leading causes of disability and pain in the world population. It is estimated that 84% of the world's population will suffer from lumbar pelvic pain in their lifetime. This high prevalence causes it to be classified as a public health problem.

Traditional primary care measures have failed to reduce the prevalence, recurrences and costs of this pathology. In the search for treatments focused on reducing public spending, the concept of tele-rehabilitation appears. It is a tool, via telematics, that provides knowledge on rehabilitation and education in neurobiology of pain, demonstrated in cardiovascular and respiratory diseases. It has been suggested that the use of this instrument could help improve the patient's quality of life at the biopsychosocial level.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Back Pain Back Pain Behavior Exercise Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rehabilitation Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Fisioterapia Villatoro-Luque

Alcalá de Henares, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18-65 years.
  • Non-specific low back pain less than 12 weeks of evolution.
  • Knowledge of new information and communication technologies.
  • Internet access.

Exclusion criteria

  • Inflammatory pathologies of the locomotor system.
  • Infectious processes.
  • Oncological processes.
  • Neurodegenerative diseases.
  • Pain with neuropathic characteristics.
  • Fractures.
  • Lack of fluency in Spanish.

Treatment and study plan

Therapeutic exercise

Other

As soon as the study investigators have obtained a significant sample of patients with non-specific sub-acute low back pain, the intervention will begin.

The principal investigator will perform an individual assessment of the patients. At the end of the assessment, he will randomly distribute them into two groups. Tele-rehabilitation group and face-to-face group.

On the one hand, the main researcher will explain the application works to the tele-rehabilitation group. For 8 weeks, they have to perform 2 therapy exercise training sessions following the instructions on the application.

On the other hand, the researcher will explain the protocol to be followed by the group face to face. In addition, he will provide a schedule to follow a correct development of the protocol. Like the tele-rehabilitation group, they will carry out 16 sessions over 8 weeks.

At the end of the protocol, the principal investigator will perform an individualized assessment of each of the study participants.

Primary outcomes

  1. Change in Quality of Life

    Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

    Using the SF-12 Questionnaire

Secondary outcomes

  1. Change in Pain perception

    Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

    Using the Visual Analog Scale (VAS) from 0 to 10

  2. Change in Disability

    Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

    Using the Oswestry Disability Questionnaire

  3. Change in Physical Activity

    Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

    Using the Baecke Physical Activity Questionnaire

  4. Change in Kinesiophobia

    Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

    Using the Tampa Kinesiophobia Scale (TSK-11) form 11 to 44

  5. Change in Sleep Quality

    Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

    Using the Pittsburgh Sleep Quality Index

  6. Change in Catastrophism

    Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

    Using the Pain catastrophizing scale from 0 to 56

  7. Change in Lumbar motor control

    Time frame: Baseline, 2 months (primary timepoint).

    Using the Rocking backward test.

  8. Change in Lumbar motor control

    Time frame: Baseline, 2 months (primary timepoint).

    Using the knee extended test.

  9. Change in Intramuscular contraction capacity erector muscles

    Time frame: Baseline, 2 months (primary timepoint).

    Using the Double straight-leg raise test.

  10. Change in Intramuscular contraction capacity erector muscles

    Time frame: Baseline, 2 months (primary timepoint).

    Using the Ito test.

  11. Change in Intramuscular contraction capacity hip flexor muscles

    Time frame: Baseline, 2 months (primary timepoint).

    Using the Hip flexion test supine position and sitting position

  12. Change in Intramuscular contraction capacity extensor flexor muscles

    Time frame: Baseline, 2 months (primary timepoint).

    Using the Hip extension test prone position

Sponsors and collaborators

Lead sponsor

Alexander Achalandabaso

Other

Registry information

Official study title

Tele-rehabilitation Versus Face-to-face in the Approach to Non-specific Subacute Low Back Pain

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2020
Registry last updated
Jul 21, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.