Clinical trial NCT04283370: A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: low back pain
electroanalgesia
exercise program
e-health
Randomized Controlled Trial
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline the acceptability and demand of the e-Health intervention for patients and physiotherapists in comparison with the home rehabilitation program for the optimization of their design, development and delivery
timeFrame: At baseline, immediate post-treatment and 6 months
measure: Change from baseline the feasibility of the trial procedures
timeFrame: At baseline, immediate post-treatment and 6 months
measure: Change from baseline adaptation of the e-Health intervention and the trial procedures for to randomized clinical trial definitive
timeFrame: At baseline, immediate post-treatment and 6 months
Secondary outcomes:
measure: Change from baseline in Roland Morris Disability Questionnaire
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Change from baseline in pain intensity. Visual analogue scale.
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Change from baseline on Quality of Life. SF-36 Health questionnaire.
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Change from Mcquade Test.
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Change from baseline in lumbar mobility flexion.
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Changes from baseline in Lumbar electromyography.
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Change from baselina in range of motion and lumbar segmental mobility
timeFrame: At baseline, at 8 weeks and at 6 months
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: Almeria University
Study officials:
affiliation: Almeria University
name: Adelaida María Castro-Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
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