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Completed

NCT Number: NCT04266366

Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program in Chronic Low Back Pain

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

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Almería

Almería, Andalusia, 04120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Face-to-Face Rehabilitation program

Other

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.

Telemedicine program

Other

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.

Primary outcomes

  1. Change from baseline in Roland Morris Disability Questionnaire (RMDQ).

    Time frame: 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 outcomes

  1. Change from baseline in disability. Oswestry Low Back Pain Disability Idex.

    Time frame: 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.

  2. Change from baseline in pain intensity. Visual analogue scale.

    Time frame: 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

  3. Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.

    Time frame: 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.

  4. Change from baseline on Quality of Life. SF-36 Health questionnaire.

    Time frame: 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.

  5. Change from Mcquade Test

    Time frame: At baseline, at 8 weeks and at 6 months

    It measures the isometric endurance of trunk flexion muscles.

  6. Change from baseline in lumbar mobility flexion.

    Time frame: 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).

  7. Changes from baseline in Lumbar electromyography.

    Time frame: 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.

  8. Change from baselina in range of motion

    Time frame: 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.

  9. Change from baselina in lumbar segmental mobility

    Time frame: 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.

  10. Change from baseline in indirect non-medical costs

    Time frame: 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.

  11. Change from baseline in direct medical costs

    Time frame: 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

  12. Change from baseline direct non-medical costs

    Time frame: At baseline, at 8 weeks and at 6 months

    The patient expenses in transportation

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Collaborators

  • Junta de Andalucia

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2020
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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