Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain
Condition: Mechanical Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Through this research is to conduct a pilot clinical trial in the treatment of chronic
      nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that
      will apply a technique of physiotherapy by passive movement of the column with oscillations
      in axial rotation at a frequency of 1.5 to 2 cps (resonance) of low amplitude (called "Pold
      Concept"), another group that applies the standard protocol of treatment for this condition,
      as used in the hospital where performed the study.

      It will compare the levels of efficiency and effectiveness of each treatment and the
      comparison between them. This will measure the perception of pain intensity and disability.
    

Detailed description: 
      Type of study:

      This is an analytical study, the experimental group clinical trial type, controlled,
      randomized with complete randomization and single blind.

      Two groups, the study to which the POLD treatment shall apply, and the control group with
      conventional treatment will be formed by complete randomization system as they arrive for
      consultation, with a total of 50 patients or more if they were needed for each group have a
      minimum of 25 having offset dropouts. The number of 25 patients per group is determined
      considering accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast,
      are required at least 21 subjects in each group to detect a minimum difference of 15
      percentage points between the two groups, therefore two groups of 25 assuming a standard
      deviation of 15 points and a loss rate of 0% tracking form.

      We will study both the effectiveness and efficiency individually and comparatively between
      groups.

        -  Study population:

             1. The sample was selected from patients attending the clinic with back pain and after
                medical diagnosis are referred to the physiotherapist report of diagnosis,
                prescribing physical therapy and who meet the criteria for inclusion and not
                exclusion .

             2. A total of 25 patients in the experimental group and 25 for the standard treatment
                group are selected.

             3. If losses to the sample will be replaced by others to maintain proportions.

        -  The selection of groups:

      RANDOM will be used , he formed the experimental group and control directing patients overall
      are being incorporated randomly according to the study :

      1. Group A ( study ) will apply the technique with an identical protocol POLD them all.

      2. Group B (conventional control) was applied average conventional treatment of different
      physiotherapy centers of reference.

        -  Study variables to collect:

             1. Subjective assessment of pain intensity using VAS, visual analog pain. ,

             2. Evolution of disability by Oswestry test.

             3. SF-12 on health.

        -  Statistical analysis:

      Computer analysis using "SPSS" 13.0 ® processed program. The study will be processed as
      follows:

      First, an initial analysis was performed to verify that there were no significant differences
      between groups in baseline values of the dependent variables by Student's t test for
      independent samples.

      Second : For each dependent variable variance analysis is applied using a general linear
      model with 2x10 between subjects factor we call variable " Treatment " with two categories 1,
      2 (experimental group = 1, conventional group = 2 ) and a temporal within-subjects factor we
      call "SHOOT" ( 10 sessions) .

      Third: We analyze to what treatment session the differences between the two groups appear by
      Student's t test for independent data after the first session

      Fourth, the interactions are studied by comparing the two groups after the first, fifth and
      10th session using a Student t test for independent data and comparing the results of each
      group between 1st and 5th session and between 1st and 10th session with a Student t for
      paired data.

      • Ethical Issues: During the study of national and international guidelines (code of ethics,
      Declaration of Helsinki) will continue, likewise the legal regulations on data privacy (Law
      15 /1999 of 13 December on the Protection of Personal Data)
    

Intervention name(s): Resonant oscillation; column exercise group
Intervention type(s): Other; Other
Intervention description(s): Resonant sustained oscillations are applied in the following areas
general column.
lumbar muscles, and paraspinal muscles,
sacral decompression oscillatory
Opening by lateral vertebral lumbar rhythmic swing.
Balancing and pelvic decompression
Swing-lumbar vertebral rotation.; paraspinal muscle stretching exercises
postural correction
mobilization exercises thoracic and lumbar
Motor control exercises
Other intervention name(s): oscillatory movement; motor control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment