Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program in Chronic Low Back Pain

Study Overview
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Brief Summary
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Perform a cost-utility analysis in patients with chronic low back pain through electroanalgesia treatment and exercises administered by telemedicine program versus face-to-face program

Detailed Description
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A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients will receive 3 weekly sessions of electroanalgesia and an exercise program for 8 weeks, for a total of 24 sessions. The aim is to analyze the cost- effectiveness of a face-to- face rehabilitation program vs a telemedicine program on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular electrical activity.

Official Title
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Comparison of Cost and Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program on Disability, Pain, Fear of Movement, Quality of Life and Spinal Mobility in Patients With Chronic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Face-to-Face Rehabilitation program
* Other: Telemedicine program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low back pain ≥ 3 months. Age between 30 and 67 years old. Not being receiving physical therapy. Exclusion Criteria: Presence of lumbar stenosis. Diagnosis of spondylolisthesis. Diagnosis of fibromyalgia. Treatment with corticosteroids or oral medication in recent weeks. History of spine surgery. Contraindication of analgesic electrical therapy. Have previously received a treatment of electrical analgesia or exercise. Central or peripheral nervous system disease.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 67 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
Interventional Model Description: Study protocol for a double blinded two-arm randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Face-to Face rehabilitation program<br>Electroanalgesia therapy and the McKenzie exercise protocol will be applied by six therapists with more than 10 years of experience. This program will be developed in the rehabilitation service of the study health centers. Patients will perform the treatment 3 times per week, for 4 weeks, with a total of 24 sessions | Other: Face-to-Face Rehabilitation program<br>* In each hospital, two trained therapists will carry out a face-to-face rehabilitation program consisting of electroanalgesia and an exercise program that follows the Mckenzie method. The physiotherapists place the electrodes in the patients, for this they use 5x9 cm electrodes, which they place at the bilateral paravertebral level, in the patients who present with radicular pain, the electrodes will be placed in the path of the affected nerve. The duration will be sufficient to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal periarticular components of the spine.<br>|
| Experimental: Telemedicine Program<br>It consists in a support system for the treatment of chronic low back pain based on web technologies. The system can register a subject and provide a treatment of electroanalgesia and exercise through the Mckenzie method. Video applications of electroanalgesia and exercises will be shown to patients who use their computer or mobile device to access the platform through the Internet. The treatments will be recommended by the system based on the database that is configured to accommodate the application of electroanalgesia and McKenzie exercises based on the diagnosis according to the McKenzie method.patients will perform the treatment 3 times per week, for 8 weeks, with a total of 24 sessions | Other: Telemedicine program<br>* It consists in an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Roland Morris Disability Questionnaire (RMDQ). | This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.Ranging from 0 points- better to 24 points- worse disability | At baseline, at 8 weeks and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in disability. Oswestry Low Back Pain Disability Idex. | It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points.The higher scores mean a worse outcome. | At baseline, at 8 weeks and at 6 months. | 
| Change from baseline in pain intensity. Visual analogue scale. | A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain. Range from no pain 0 to maximum pain 10 points | At baseline, at 8 weeks and at 6 months | 
| Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia. | Is a 17-item questionnaire that measures the fear of movement and (re)injury.Patient rate beliefs about their kinesiophobia on a 4-point scale ranging from strongly disagree to strongly agree. | At baseline, at 8 weeks and at 6 months | 
| Change from baseline on Quality of Life. SF-36 Health questionnaire. | SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life. | At baseline, at 8 weeks and at 6 months | 
| Change from Mcquade Test | It measures the isometric endurance of trunk flexion muscles. | At baseline, at 8 weeks and at 6 months | 
| Change from baseline in lumbar mobility flexion. | For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil). | At baseline, at 8 weeks and at 6 months | 
| Changes from baseline in Lumbar electromyography. | The degree of electromyographic activation of the lumbar paravertebral musculature will be carried out by using a set of electrodes of 3x7 dimensions that will be applied uniformly in the lumbar region from the spinal level from L2 to L5. | At baseline, at 8 weeks and at 6 months | 
| Change from baselina in range of motion | This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way. | At baseline, at 8 weeks and at 6 months | 
| Change from baselina in lumbar segmental mobility | This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way. | At baseline, at 8 weeks and at 6 months | 
| Change from baseline in indirect non-medical costs | sick leave days due to low back pain and labor absenteeism costs in terms of workdays lost due to illness at salary level. | At baseline, at 8 weeks and at 6 months | 
| Change from baseline in direct medical costs | costs of visits to primary care, emergency visits, home help received as a result of disability related to LBP, diagnostic tests and pharmaceutical products | At baseline, at 8 weeks and at 6 months | 
| Change from baseline direct non-medical costs | The patient expenses in transportation | At baseline, at 8 weeks and at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Electroanalgesia, McKenzie Method, Telemedicine, Study protocol for a Randomized clinical trial