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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 1, 2022

Detailed Description

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.

Interventions

  • Other: Face-to-Face Rehabilitation program
    • 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 5×9 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.
  • Other: Telemedicine program
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: Face-to Face rehabilitation program
    • 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
  • Experimental: Telemedicine Program
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • 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

Secondary Measures

  • Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
    • Time Frame: At baseline, at 8 weeks and at 6 months.
    • 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.
  • Change from baseline in pain intensity. Visual analogue scale.
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • 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
  • Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • 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.
  • Change from baseline on Quality of Life. SF-36 Health questionnaire.
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
  • Change from Mcquade Test
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • It measures the isometric endurance of trunk flexion muscles.
  • Change from baseline in lumbar mobility flexion.
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil).
  • Changes from baseline in Lumbar electromyography.
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • The degree of electromyographic activation of the lumbar paravertebral musculature will be carried out by using a set of electrodes of 3×7 dimensions that will be applied uniformly in the lumbar region from the spinal level from L2 to L5.
  • Change from baselina in range of motion
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • 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.
  • Change from baselina in lumbar segmental mobility
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • 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.
  • Change from baseline in indirect non-medical costs
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • sick leave days due to low back pain and labor absenteeism costs in terms of workdays lost due to illness at salary level.
  • Change from baseline in direct medical costs
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • costs of visits to primary care, emergency visits, home help received as a result of disability related to LBP, diagnostic tests and pharmaceutical products
  • Change from baseline direct non-medical costs
    • Time Frame: At baseline, at 8 weeks and at 6 months
    • The patient expenses in transportation

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 67 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad de Almeria
  • Collaborator
    • Funding: Junta de Andalucía
  • Provider of Information About this Clinical Study
    • Principal Investigator: Adelaida María Castro-Sánchez, Principal Investigator – Universidad de Almeria
  • Overall Official(s)
    • Adelaida María Castro-Sánchez, PhD, Principal Investigator, Almería University

References

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Khadilkar A, Milne S, Brosseau L, Robinson V, Saginur M, Shea B, Tugwell P, Wells G. Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD003008. doi: 10.1002/14651858.CD003008.pub2.

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