A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain

Universidad de Almeria

Status: Completed

Conditions: Chronic Low-back Pain

Treatments: Other: Home Rehabilitation Program; Other: e-Health program

Study type: Interventional

Funder types: Other

Identifiers

NCT04283370

PC-0185-2017

Details and patient eligibility

About

The aim of this randomized controlled trial is to evaluate the feasibility and effectiveness of providing an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the McKenzie Method for patients with chronic low back pain in primary care, compared with the same home rehabilitation program but without the support of an electronic 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 effectiveness of a home rehabilitation program vs a web platform program on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular electrical activity.

Enrollment: 80 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.
• Score ≥ 4 points on the Roland Morris Disability Questionnaire.
• 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.
• Agoraphobia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Home rehabilitation program

Experimental group

Description:

It consists in a home rehabilitation program. Patients will recieve electroanalgesia with TENS and an exercise program following the McKenzie method. At first and second sessions, patients will be instructed on how to use electroanalgesia and how to perform the exercises. Then, patients will perform the therapy at home. Patients will perform the treatment 3 times per week, for 4 weeks, with a total of 24 sessions

Treatment:

Other: Home Rehabilitation Program

e-Health program

Active Comparator 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 4 weeks, with a total of 24 sessions

Treatment:

Other: e-Health program