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

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ClinicalTrials.gov Identifier: NCT04283370
Recruitment Status : Completed
First Posted : February 25, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Adelaida María Castro-Sánchez, Universidad de Almeria

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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Other: Home Rehabilitation Program Other: e-Health program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 25, 2020
Actual Primary Completion Date : October 20, 2020
Actual Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home rehabilitation program
It consists in a home rehabilitation program. Patients will recieve electroanalgesia with TENS and an exercise program following the McKenzie method. At first and second sessions, patients will be instructed on how to use electroanalgesia and how to perform the exercises. Then, patients will perform the therapy at home. Patients will perform the treatment 3 times per week, for 4 weeks, with a total of 24 sessions
Other: Home Rehabilitation Program
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.

Active Comparator: e-Health program
It consists in a support system for the treatment of chronic low back pain based on web technologies. The system can register a subject and provide a treatment of electroanalgesia and exercise through the Mckenzie method. Video applications of electroanalgesia and exercises will be shown to patients who use their computer or mobile device to access the platform through the Internet. The treatments will be recommended by the system based on the database that is configured to accommodate the application of electroanalgesia and McKenzie exercises based on the diagnosis according to the McKenzie method.patients will perform the treatment 3 times per week, for 4 weeks, with a total of 24 sessions
Other: e-Health 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   30 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283370


Locations
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Spain
Almeria University
Almeria, Spain, 04001
Sponsors and Collaborators
Universidad de Almeria
Investigators
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Principal Investigator: Adelaida María Castro-Sánchez, PhD Almeria University
Publications:

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Responsible Party: Adelaida María Castro-Sánchez, Principal Investigator, Universidad de Almeria
ClinicalTrials.gov Identifier: NCT04283370    
Other Study ID Numbers: PC-0185-2017
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adelaida María Castro-Sánchez, Universidad de Almeria:
low back pain
electroanalgesia
exercise program
e-health
Randomized Controlled Trial
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations