Low Back Pain
Conditions
Keywords
Low back pain, Electroanalgesia, McKenzie Method, Telemedicine, Study protocol for a Randomized clinical trial
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.
Interventions
In each hospital, two trained therapists will carry out a face-to-face rehabilitation program consisting of electroanalgesia and an exercise program that follows the Mckenzie method. The physiotherapists place the electrodes in the patients, for this they use 5x9 cm electrodes, which they place at the bilateral paravertebral level, in the patients who present with radicular pain, the electrodes will be placed in the path of the affected nerve. The duration will be sufficient to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal periarticular components of the spine.
OTHERTelemedicine 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.
Sponsors
Junta de Andalucia
Universidad de Almeria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Study protocol for a double blinded two-arm randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 67 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Roland Morris Disability Questionnaire (RMDQ). | At baseline, at 8 weeks and at 6 months | This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.Ranging from 0 points- better to 24 points- worse disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pain intensity. Visual analogue scale. | At baseline, at 8 weeks and at 6 months | A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain. Range from no pain 0 to maximum pain 10 points |
| Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia. | At baseline, at 8 weeks and at 6 months | Is a 17-item questionnaire that measures the fear of movement and (re)injury.Patient rate beliefs about their kinesiophobia on a 4-point scale ranging from strongly disagree to strongly agree. |
| Change from baseline on Quality of Life. SF-36 Health questionnaire. | At baseline, at 8 weeks and at 6 months | SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life. |
| Change from Mcquade Test | At baseline, at 8 weeks and at 6 months | It measures the isometric endurance of trunk flexion muscles. |
| Change from baseline in lumbar mobility flexion. | At baseline, at 8 weeks and at 6 months | For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil). |
| Change from baseline in disability. Oswestry Low Back Pain Disability Idex. | At baseline, at 8 weeks and at 6 months. | It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points.The higher scores mean a worse outcome. |
| Change from baselina in range of motion | At baseline, at 8 weeks and at 6 months | This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way. |
| Change from baselina in lumbar segmental mobility | At baseline, at 8 weeks and at 6 months | This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way. |
| Change from baseline in indirect non-medical costs | At baseline, at 8 weeks and at 6 months | sick leave days due to low back pain and labor absenteeism costs in terms of workdays lost due to illness at salary level. |
| Change from baseline in direct medical costs | At baseline, at 8 weeks and at 6 months | costs of visits to primary care, emergency visits, home help received as a result of disability related to LBP, diagnostic tests and pharmaceutical products |
| Change from baseline direct non-medical costs | At baseline, at 8 weeks and at 6 months | The patient expenses in transportation |
| Changes from baseline in Lumbar electromyography. | At baseline, at 8 weeks and at 6 months | The degree of electromyographic activation of the lumbar paravertebral musculature will be carried out by using a set of electrodes of 3x7 dimensions that will be applied uniformly in the lumbar region from the spinal level from L2 to L5. |
Countries
Spain
Outcome results
None listed