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Completed

NCT Number: NCT04283370

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

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.

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Key information

Conditions

Chronic Low-back Pain Back Pain Low 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

Almeria University

Almería, 04001, 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 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.

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.
  • 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

Treatment and study plan

Home Rehabilitation Program

Other

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.

E-health 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 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

    Time frame: At baseline, immediate post-treatment and 6 months

    The extent to which participants who have received the intervention through a web application consider that the content and support materials (web application and initial learning sessions) are appropriate and satisfactory to obtain the expected results.The extent to which the physiotherapists who have administered the intervention consider that the training, content and support materials are appropriate.Brief questionnaire developed for this trial* 10-items Patients rate their acceptability and demand of treatment received and trial participation, including the burden of outcome measure completion. Measured with 10-point numeric rating scales ranging from not at all satisfactory to extremely satisfactory

  2. Change from baseline the feasibility of the trial procedures

    Time frame: At baseline, immediate post-treatment and 6 months

    The extent to which participants believe that their eligibility, outcome measures, follow-up and intervention by the physiotherapist have been satisfactory.

    The extent to which physiotherapists who have participated in the trial consider recruitment, outcome measures, evaluation follow-ups and appropriate and satisfactory intervention procedures.Brief questionnaire developed for this trial* 4-items Measured with 10-point numeric rating scales ranging from not at all helpful to extremely helpful

  3. Change from baseline adaptation of the e-Health intervention and the trial procedures for to randomized clinical trial definitive

    Time frame: At baseline, immediate post-treatment and 6 months

    The extent to which the content of the e-health intervention, support materials and learning classes should be modified to improve their acceptability and implementation for a future definitive trial The extent to which recruitment, follow-up procedures and the number and outcome measures should be modified during / at the end of the trial to improve its acceptability and implementation for a definitive future trial.Brief questionnaire developed for this trial* 11-items Measured using yes/no responses

Secondary outcomes

  1. Change from baseline in Roland Morris Disability Questionnaire

    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

  2. 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

  3. 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

  4. 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.

  5. 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.The higher the score, the higher the quality of life

  6. Change from Mcquade Test.

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

    It measures the isometric endurance of trunk flexion muscles in seconds.

  7. 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).

  8. 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.

  9. Change from baselina in range of motion and 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.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2020
Registry last updated
Sep 21, 2023

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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