New Technologies in the Management of Lumbopelvic Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Back Pain, Rehabilitation, Exercise

Intervention / Treatment
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* Other: therapeutic exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-rehabilitation group<br>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. | Other: therapeutic exercise<br>* 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.<br>|
| Experimental: Face to face group<br>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. | Other: therapeutic exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | Using the SF-12 Questionnaire | Baseline, 2 months (primary timepoint), 3 months after intervention commencement. | 

Secondary Outcome Measures

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