Effectiveness of Therapeutic Exercise App Adding a Face-to-face Physical Therapist in Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low Back Pain (LBP) is one of the most usual illness in our society. Therapeutic Exercise
      (TE) has been shown the most effective and cheaper treatment in patients suffering LBP, but
      the lack of engagement to the therapeutic exercise programs is related with later acute LBP
      and chronic situations, despite symptoms slightly improve.

      The value of personalized therapeutic exercised programs in patients suffering LBP has been
      shown nowadays, improving symptomatology and quality of life.

      New technologies help patients to engage more in treatment, while time that health education
      make people "active patients".

      The aim of the study is to evaluate the effectiveness of a Home Therapeutic Exercise Program
      (HTEP) based in an app with McGill's exercised adding 6 face-to-face sessions every 15 days
      with a physical therapist .
    

Detailed description: 
      INTRODUCTION

      Low back pain is defined as pain and discomfort, localized below the costal margin and above
      the inferior gluteal folds, with or without leg pain . Sub-acute low back pain as low back
      pain persisting between 6 and 12 weeks; chronic low back pain as low back pain persisting for
      12 weeks or more. It is not usual define specific causes of LBP, no more than 15 % patients
      have a define cause. Non-specific low back pain is defined as low back pain not attributed to
      recognizable, known specific pathology (e.g. infection, tumor, osteoporosis, ankylosing
      spondylitis, fracture, inflammatory process, radicular syndrome or cauda equina syndrome).

      LBP is one of main world health problems, 23.9 % world citizens suffer LBP over a month in
      their life. World aging foresee this percentage will increase more in women from 40 to 80
      years old. In 2017 LBP was an important men and women chronic health problem in Spain, the
      second cause more important in women with 23.5 % Spanish women suffering it and the third one
      in men with 15.8 % Spanish men suffering it. LBP is also the most important cause of work
      absenteeism with general back pain and migraine.

      LBP is related with sedentary lifestyle. Recurrent low back pain is usual. There are several
      studies searching LBP's risks and LBP's risks factors but they did not show a clear reason.

      Studies about app beef up treatment engagement and treatment effectiveness. Last studies
      about engagement and health improvement using app had shown positive results in diabetes
      patients, hypertension patients, heart pathology or daily pain management without help (for
      example Keele Pain Recorder app).

      There is a wide and proven evidence of the improvement in symptomatology using app to
      prescribe exercise in patients suffering LBP according to Sunil et al papers (aerobic daily
      programs plus 7 specific exercise towards LBP treatment), proposing health mobile apps as an
      important tool to chronic pathologies.

      But in front of the positive situation of a better engagement, app use has a couple of
      limitations as the reinforcement that a face-to-face control provides ant the information
      that a specialist health professional can add to the app mobile development to improve the
      final results.

      JUSTIFICATION

      LBP is one of the most important health problems of our society. The present study postulates
      the possible link between technology and real treatment, proposing a HTEP created to
      non-specific LBP with an app, using McGill's Big Three exercise as the base of the program.

      McGill's Big Three Exercise are 3 basic and low complexity exercises to treat any patient who
      is suffering non-specific low back pain, that had shown a real effectiveness in order to
      reduce pain intensity and to get better functionality. McGill proposed 3-exercise warm up
      before the Big Three "Curl up", "Side Bridge" and "Bird Dog" that had to be executed in an
      isometric contraction. Maximal muscular contraction had to be under 8 seconds, because longer
      contraction would reduce effectiveness as McGill showed in one of his studies.

      The study will propose an individualized McGill Program using an app as support to the two
      arms of the study, and the main difference will be that experimental group will have a
      face-to-face control every 15 days and the control group will work only with the app.

      App development has the supervision or three specialized physical therapists in LBP.

      HYPOTHESIS

      The addition of 6 face-to-face sessions executed by physical therapist to the personalized
      HTEP provided by the app is more effective at improving pain intensity, functionality,
      quality of life and treatment engagement in patients suffering non-specific LBP.

      OBJECTIVES

      General:

      Evaluate the effectiveness of adding face-to-face supervision sessions executed by Physical
      Therapist to a HTEP with an app in people suffering non-specific LBP.

      Specifics

        1. Evaluate the effectiveness of adding face-to-face supervision sessions executed by
           Physical Therapist to a HTEP with an app in people suffering non-specific LBP reducing
           pain intensity measured by PI-NRS.

        2. Evaluate the effectiveness of adding face-to-face supervision sessions executed by
           Physical Therapist to a HTEP with an app in people suffering non-specific LBP improving
           functionality measured by Oswestry scale.

        3. Evaluate the effectiveness of adding face-to-face supervision sessions executed by
           Physical Therapist to a HTEP with an app in people suffering non-specific LBP improving
           life quality of life measured by SF-12 scale.

        4. Evaluate patient satisfaction degree of a semi presential treatment measured by PSQ.

        5. Evaluate the effectiveness of adding face-to-face supervision sessions executed by
           Physical Therapist to a HTEP with an app in people suffering non-specific LBP improving
           engagement treatment analyzing app database.

      METHODOLOGY

      Type of study: randomized and controlled pilot study, in a two arms study with parallel
      interventions the experimental one and the control one. The study will blind randomization,
      patient assessment and data analysis. Patient randomization will take place at "Universidad
      Complutense de Madrid" using random permutations model of Moses and Oakford. Study
      characteristics itself prevent their blinded application cause:

        -  Evaluators (baseline, intervention, and post-intervention) will be different
           professionals that physical therapist will provide face-to-face sessions, and they will
           ignore in which group patients are in.

        -  Physical therapist that provide face-to-face sessions will not have any evaluation data.

      This study will assure blinded randomization assessment, recruiters and evaluators of
      assessment group of each patient.

      Location: Universidad Complutense de Madrid. Study Subjects: 90 patients suffering
      non-specific LBP

      Sample size: This study has a paper published in 2018 as reference and the standard deviation
      was 2 in pain measure variable.

      Accepting an alpha risk of 0.5 and a beta risk of 0.2 in a two-sided test, 90 subjects (45 in
      the control group and 45 in the experimental group) are necessary to recognize as
      statistically significant a difference greater than or equal to 1.5 units. The standard
      deviation is assumed to be 2, and it has been anticipated a drop-out rate of 10 %.

      Data collection and analysis. Before starting the study, all patients will be asked to sign
      an informed consent in the first session where it will take place the initial assessment
      including the collection of patient data records and the booklet of questionnaires and
      clinical measurements using the app.

      The patient will receive weekly 3 sessions of his personalized HTEP and experimental group
      will receive also 6 group session every 15 days t controlled by a physical therapist.

        1. At first session, before treatment, variables PI-NRS, SF-12 and Oswestry variables will
           be measured.

        2. 2 weeks after baseline, before treatment, PI-NRS variable will be measured.

        3. 4 weeks after baseline, before treatment, SF-12 and Oswestry variables will be measured.

        4. 6 weeks after baseline, before treatment, PI-NRS variable will be measured.

        5. 8 weeks after baseline, before treatment, SF-12 and Oswestry variables will be measured.

        6. 10 weeks after baseline, before treatment, PI-NRS variable will be measured.

        7. 12 weeks after baseline the patient will be re-evaluated. PI-NRS, Oswestry, SF-12, PSQ
           and engagement variables will be measure The following week to the end of treatment, the
           patient will be re-evaluated.

      The statistical analysis will be performed using SPSS 22.0 program (IBM statistical
      software).

      The average and the standard deviation of quantitative variables will be calculated for the
      descriptive analysis of the sample. In non-normal distributions the nonparametric sum of the
      ranges of Wilcoxon and Chi Square test will be performed, as well as the homogeneity in
      baseline will be displayed by overlapping confidence intervals.

      For the comparative analysis, developed according to the intention to treat:

        1. A MANOVA (ANOVA for repeated measures) test should be carry out to evaluate the
           interaction between levels of inter - subject factor (treatment) and the intra- subject
           (main variables response in time) to be interpreted in case it is significant.

        2. To confirm whether this interaction effect is significant, pairwise comparisons will be
           made of the inter-subjects factor levels (treatment) for each level of main response
           variables over time using the Bonferroni method.

      Limitations of the study and measures taken to reduce them.

      Masking: The nature of the applied treatments prevents masking therapists and patients. This
      limitation is inherent to the type of treatment evaluated and common with other forms of
      treatment with similar characteristics, in which therapist should inevitably know the type of
      treatment that is applied.

      However, this limitation does not prevent the controlled clinical trials carried out on these
      technologies from being of higher methodological quality. Thus, in this study, randomization
      of patients will be blind, allocation of the random sequence, the assessment of patient
      evolution and analysis of results.
    

Intervention name(s): App and face-to-face physical therapy; App physical therapy
Intervention type(s): Other; Other
Intervention description(s): Patients will use an app with health tests, general information about the study, personalized HTEP based in McGill's Program after their evaluations, and several online materials related with healthcare and healthy habits linked to social media sites. During the app used they will have 6 face-to-face sessions in 6 people groups with a physical Therapist in a 3 months period; Patients will use an app with health tests, general information about the study, personalized HTEP based in McGill's Program after their evaluations, and several online materials related with healthcare and healthy habits linked to social media sites.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physiotherapy; Mobile Applications; Therapeutic Exercise