NCT04283370

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

A Study Protocol Randomised Feasibility Trial Comparing a Home Rehabilitation Program Versus e-Health Program on Disability, Pain, Fear of Movement, Quality of Life and Spinal Mobility in Non-specific Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Universidad de Almeria · Academic / Other
• Sex: All
• Age: 30 Years – 67 Years
• Healthy volunteers: Not accepted

Summary

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.

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 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.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
OTHER	Home Rehabilitation Program	It consists in a home rehabilitation program 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.
OTHER	e-Health 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.

Timeline

• Start date: 2020-09-05
• Primary completion: 2021-04-30
• Completion: 2021-10-31
• First posted: 2020-02-25
• Last updated: 2023-09-21

Locations

1 site across 1 country: Spain