Physiotherapy Re-education of Pre-activation of the Transverse Abdominis in Patients With Chronic Low Back Pain
Condition: Chronic Non-specific Low-Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Hypothesis: The hypothesis of the study is that the physiotherapeutic re-education of the
      pre-activation of the transverse abdominal muscle decreases pain intensity in patients with
      chronic non-specific low-back pain by at least 30% and is more effective than conventional
      treatment.

      Aims: the principal aim is to determine the effectiveness of a physiotherapeutic re-education
      program based on the pre-activation of the transverse abdominal muscle on pain intensity in
      adult patients diagnosed with chronic non-specific low-back pain compared to conventional
      treatment in a primary care setting. The secondary aims of the study are to assess the
      effects of a physiotherapeutic re-education program based on the pre-activation of the
      transverse abdominal muscle on: (1) disability and limitations for the development of the
      activities of daily living associated with LBP, (2) transverse abdominal muscle muscle
      contraction, (3) to assess whether the resistance training parameters applied to older adults
      are valid for young adults and (4) to determine whether the training protocols used for the
      cervical spine could be extrapolated to the lumbar spine.
    

Detailed description: 
      This study will be a parallel randomized controlled trial. Participants between 18-65 years
      old, diagnosed with chronic nonspecific low-back pain, who will sign the informed consent,
      will be included in the study. Participants will be excluded if they are diagnosed with
      cognitive impairments, if the presence of any "Red Flag" is identified, women on pregnancy or
      postpartum less than three months and participants with difficulties understanding and/or
      speaking Spanish or Catalan.

      Based upon the results of a systematic review about the effectiveness of physical therapy
      based treatment for low back pain, a reduction in 15 points of pain intensity assessed
      through Visual Analogue Scale will be considered for sample size calculation. Therefore,
      accepting an alfa risk of 0.05, a beta risk less than 0.2 and assuming a 15% of withdrawals a
      sample size of 108 participants has been estimated for this study.

      Participants will be recruited from Primary Care Centers of the city of Lleida (Catalonia,
      Spain). They will be first contacted by telephone and the suitability of each participant
      will be assessed trough a brief interview. After participant selection via telephone, those
      who meet the inclusion criteria will be invited to have a personal interview with the
      researchers in order to solve any doubt and to read and sign the written informed consent. To
      ensure all participants understand the study, they will simply be asked about general study
      information (i.e. objectives, treatment and control conditions, etc.).

      The included participants will be assigned either to the experimental or the control group
      using a simple randomization method. The allocation will be concealed to both, the
      physiotherapists who will make the assessments (pre- and post-treatment and follows-up) of
      the participants and the researcher who will manage the results data.

      Participants in the experimental group will receive an individualized physiotherapeutic
      re-education program based on the pre-activation of the transverse abdominal muscle. The
      intervention will last 4-weeks and will consist on two weekly sessions of 30-35 minutes each.
      Each session will be divided into two main parts (1) warm-up and (2) re-education of the
      pre-activation of the transverse abdominal muscle.

        1. . Warm-up (5 minutes): lumbopelvic dissociation exercises, increasing difficulty each
           week.

        2. . Re-education of the pre-activation of the transverse abdominal muscle (25-30 minutes)
           First session: participants will learn how to contract appropriately the transverse
           abdominal muscle through basic and easy exercises. In order to facilitate the
           contraction, one physiotherapist will monitor the lumbopelvic motion by placing a
           Pressure Biofeedback Unit under the participants' lumbar spine.

      The authors will calculate the 75% of one-rep max (1RM) and the seconds that each participant
      can maintain the 75% 1RM contraction. This will allow to establish individualized times for
      carrying out the exercises during the following sessions.

      Following sessions: 16 re-educational exercises have been design. In each session, the
      participants will perform four different exercises, increasing each week the difficulty and
      the degree of loading. The participants will perform the exercises based on their 75% 1RM
      calculation, completing 3 series of 9 repetitions, holding each repetition a maximum of 6
      seconds. It will be a pause of 4 sec. between each exercise and a pause of 60 seconds between
      each series. The 75% 1RM will be calculated in each session.

      Participants in the control group will follow the conventional treatment prescribe by their
      general practitioner in primary care.

      Participants in both groups will be assessed pre- and post-treatment with a follow-up at 3, 6
      and 12 months.

      All statistical analyses will be carried out using the statistical program 'PASW 20'. An
      intention to treat analysis will be performed.

      Expected outcomes: the authors expect that patients in the experimental group will achieve a
      greater (1) reduction in pain intensity, (2) improvement of disability associated with CLBP,
      (3) improvement in the development of activities of daily living, and (4) contraction of the
      transvers abdominal muscle, compared to patients in the control group.
    

Intervention name(s): Physiotherapy re-education program; Conventional treatment by GP
Intervention type(s): Other; Other
Intervention description(s): Physiotherapy Program based on the Re-education of Pre-activation of the Transverse Abdominal Muscle; Patients will follow the general practitioner's advice including medication if needed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Non-specific Low-Back Pain; Chronic Low-Back Pain; Physiotherapy; Therapeutic Exercise; Primary Care; Transverse Abdominal Muscle