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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Face-to-Face Rehabilitation program; Other: Telemedicine program

• Registration Number: NCT04266366
• Lead Sponsor: Universidad de Almeria

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-12
• Study Start: 2020-03-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-10-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• Low back pain ≥ 3 months.
• Age between 30 and 67 years old.
• Not being receiving physical therapy.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face-to Face rehabilitation program	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
Telemedicine Program	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

Primary Outcome Measures

Name	Time	Method
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).	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 Outcome Measures

Name	Time	Method
Change from baseline in disability. Oswestry Low Back Pain Disability Idex.	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 direct medical costs	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	At baseline, at 8 weeks and at 6 months	The patient expenses in transportation
Change from baseline on Quality of Life. SF-36 Health questionnaire.	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 baselina in range of motion	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 pain intensity. Visual analogue scale.	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 lumbar mobility flexion.	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).
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.	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 Mcquade Test	At baseline, at 8 weeks and at 6 months	It measures the isometric endurance of trunk flexion muscles.
Change from baseline in indirect non-medical costs	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.
Changes from baseline in Lumbar electromyography.	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 3x7 dimensions that will be applied uniformly in the lumbar region from the spinal level from L2 to L5.
Change from baselina in lumbar segmental mobility	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.

Trial Locations

Locations (1)

Universidad de Almería; 🇪🇸 Almería, Andalucía, Spain