New Technologies in the Management of Lumbopelvic Pain

Not Applicable

Completed

• Conditions: Rehabilitation; Low Back Pain; Exercise
• Interventions: Other: therapeutic exercise

• Registration Number: NCT04685837
• Lead Sponsor: Alexander Achalandabaso

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-17
• Study Start: 2020-12-21
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Primary Completion: 2021-04-15
• Study Completion: 2021-06-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face to face group	therapeutic exercise	Participants randomly assigned to the face-to-face group will use the physical therapy clinic to do the exercises controlled by the principal investigator. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the protocol works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator.
Tele-rehabilitation group	therapeutic exercise	The participants randomly assigned to the tele-rehabilitation group will use a computer application to know and execute the exercise protocol. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the application works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator.

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.	Using the SF-12 Questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in Sleep Quality	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.	Using the Pittsburgh Sleep Quality Index
Change in Pain perception	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.	Using the Visual Analog Scale (VAS) from 0 to 10
Change in Intramuscular contraction capacity erector muscles	Baseline, 2 months (primary timepoint).	Using the Ito test.
Change in Intramuscular contraction capacity hip flexor muscles	Baseline, 2 months (primary timepoint).	Using the Hip flexion test supine position and sitting position
Change in Kinesiophobia	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.	Using the Tampa Kinesiophobia Scale (TSK-11) form 11 to 44
Change in Disability	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.	Using the Oswestry Disability Questionnaire
Change in Physical Activity	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.	Using the Baecke Physical Activity Questionnaire
Change in Catastrophism	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.	Using the Pain catastrophizing scale from 0 to 56
Change in Lumbar motor control	Baseline, 2 months (primary timepoint).	Using the knee extended test.
Change in Intramuscular contraction capacity extensor flexor muscles	Baseline, 2 months (primary timepoint).	Using the Hip extension test prone position

Trial Locations

Locations (1)

Centro de Fisioterapia Villatoro-Luque; 🇪🇸 Alcalá De Henares, Spain