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

Universidad de Almeria

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Telemedicine program; Other: Face-to-Face Rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT04266366

CE-IP00562

Details and patient eligibility

About

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 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.

Enrollment: 540 patients

Sex: All

Ages: 30 to 67 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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540 participants in 2 patient groups

Face-to Face rehabilitation program

Active Comparator group

Description:

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

Treatment:

Other: Face-to-Face Rehabilitation program

Telemedicine Program

Experimental group

Description:

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

Treatment:

Other: Telemedicine program