Clinical trial NCT04266366: Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program in Chronic Low Back Pain
Official title: Comparison of Cost and Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program on Disability, Pain, Fear of Movement, Quality of Life and Spinal Mobility in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Electroanalgesia
McKenzie Method
Telemedicine
Study protocol for a Randomized clinical trial
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Junta de Andalucia
First posted: 2020-02-12
Enrollment: 540
Sex: ALL
Minimum age (years): 30
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study protocol for a double blinded two-arm randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
timeFrame: At baseline, at 8 weeks and at 6 months
Secondary outcomes:
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
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Change from baselina in lumbar segmental mobility
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Change from baseline in indirect non-medical costs
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Change from baseline in direct medical costs
timeFrame: At baseline, at 8 weeks and at 6 months
measure: Change from baseline direct non-medical costs
timeFrame: At baseline, at 8 weeks and at 6 months
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almería
state: Andalucía
Study officials:
affiliation: Almería University
name: Adelaida María Castro-Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
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