Visceral Manipulation in Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Non-specific chronic low back pain is a common multifactorial condition common to the world
      population. It is defined as a pain and discomfort located below the ribs and above the
      gluteal folds that may or may not have referred pain in the leg for more than 12 weeks.
      Visceral manipulation is a manual therapy technique that aims to normalize mechanical,
      vascular and neurological dysfunctions of the viscera with the objective of improving its
      functioning. Visceral dysfunction may potentially activate or exacerbate the symptoms of low
      back pain in the presence of compromised movements between the internal organs and its
      connective tissues. There are two ways in which a change in visceral mobility could interfere
      with low back pain, referred visceral pain and central hypersensitivity. The first occurs due
      to neural convergence, since there is no spinocortical tract that only sends visceral or
      somatic afferences, its afferences are crossed in the dorsal horn of the spinal cord. The
      second is that the prolonged and continuous activation of nociceptors, due to the alteration
      in the mobility of the gastrointestinal and urinary system, can generate central
      hypersensitivity. Therefore, the investigators hypothesized that through the visceral
      manipulation the fascial adherences would lyse and the visceral spasms would demise, reducing
      the peripheral input, thus, lessening pain in the low back.
    

Detailed description: 
      Ethical aspects: All volunteers will be informed about the experimental procedures that will
      be submitted, as well as the fact that these do not affect the participant's health. The
      participants will also be clarified as to the secrecy of the information collected during the
      study performance, protecting the identities of the participants. After agreeing to
      participate in the research, each volunteer will sign the Informed Consent Term, according to
      resolution 196/96 and update in resolution 466 in 2012 of the National Health Council.

      Risks:The interventions offer no harm to the participant's health. There is the possibility
      of the participant feeling pain and / or tickling during abdominal palpation. If these
      sensations occur, the procedure will be stopped and tried again. If sensations persist and
      the participant can not support them the session will be rescheduled or the participant will
      be disconnected from the study as there is no other way to carry out the proposed therapy.

      Benefits:There may be no direct or immediate benefits, however, it is expected that the
      proposed treatment will improve lumbar pain.

      This study does not offer any type of health insurance, and also, it is the responsibility of
      the participant to get around and bear the costs of transportation to the place of collection
      of data.

      Confidentiality and privacy of research participants will be guaranteed during all phases of
      the research. At any time the participant can withdraw consent to participate in the research
      without any kind of penalty.

      The research team is committed to making the search results public, whether favorable or not.

      It is worth noting that the placebo intervention procedures will always be performed in
      association with an active treatment, which makes its use of less impact to the patient. In
      addition, all patients will be informed of the use of this procedure prior to the initiation
      of the survey.

      Criteria for suspending research: This research will be suspended in the event of
      researchers' deaths, closure of the research site or termination of the Term of Science of
      the Partner Condition and / or no volunteer to participate in the research.

      Financing This study will be funded by the researchers themselves.

      Source of Patients: Patients with chronic low back pain will be referred for screening from
      online surveys, third party indications, and from patients on the waiting list of the Heath
      Center of the University of Sorocaba. The screening, assessment and evaluation will be
      performed at the Health Nucleus and in the Integrated Human Movement Laboratory of the
      University of Sorocaba.

      Procedure: The researchers will inform the study objectives and procedures to all patients.
      If the participants agree to participate, the participants will sign an informed consent
      form. After that, a therapist will assess them for demographic data and baseline measures,
      such as pain level (0-10 Numerical Pain Rating Scale), disability associated with low back
      pain (Roland-Morris Disability Questionnaire), and function (0-10 Patient-Specific Functional
      Scale)

      Random Allocation: One of the researchers will create a randomization code with 1:1
      allocation radio using Excel for Windows software. The codes will be the words "E" for
      experimental or "P" for placebo, then ithe codes will be sealed on opaque envelopes, thus
      ensuring the concealed allocation of participants to groups. At the first encounter with the
      treating therapist, patients will choose one of the envelopes on a table and give it to the
      therapist. The therapist will open it in a different room from the patient and allocate the
      patient to the group according to the randomization schedule.

      Interventions: The volunteers will be allocated in the Experimental group or the Control
      Group. In the Experimental, the participants will receive the Standard care physiotherapy
      plus Active visceral manipulation, while the Control will receive Standard care physiotherapy
      and Placebo visceral manipulation. The standard care physiotherapy lasts 40 minutes and the
      visceral mobilisation takes around 10 minutes.

      Blinding: The assessor and the therapist will be blind to each others work. Therefore the
      assessor will not have knowledge of the treatment allocation and will perform three
      assessments, the pre assessment, immediately after the last treatment and 1 week after the
      treatment. Similarly, the therapist will not know the pre- and post-assessment intervention.
      In addition, there will be only one assessor and one therapist for the research to decrease
      bias. To test the blinding, after the last treatment session, the assessor will write on the
      patient's assessment chart which type of intervention (active or placebo) he thought the
      participant had received. These codes will be later compared with the randomization codes.

      Statistical methods: Statistical analysis will be used SPSS (Statistical Package for Social
      Sciences) v.19.0. Initially the Kolmogorov-Smirnov test will be performed. If the data are
      normal, parametric tests will be applied, if the distribution is non-normal, non-parametric
      tests will be used. It will be calculated from the effect size, by means of the difference
      between the means of the pre-intervention evaluation and the post-intervention evaluation. In
      all analyzes, a critical level of 5% (p <0.05) will be set.
    

Intervention name(s): Active Visceral Manipulation; Standard care physiotherapy; Placebo Visceral Manipulation
Intervention type(s): Other; Other; Other
Intervention description(s): Visceral manipulation techniques consists of deep manual pressure in certain points of the abdomen and the amount of pressure will be respected according to the participant discomfort or pain. It will be performed cardia mobilization, pylori mobilization, Oddi's sphincter mobilization, duodenum-jejunum valve mobilization, ileocecal valve mobilization, global technique for the liver, global hemodynamic technique. Each technique will last 1 minutes, with the two last ones repeated 10 times.; The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes.; The placebo intervention involves light touch at the same regions of the techniques the active visceral manipulation, and no intention on the part of the therapist to impart any therapeutic technique
Other intervention name(s): Active Visceral Mobilization; Direct Visceral Mobilization; Conventional physiotherapy; Placebo Visceral Mobilization; Indirect Visceral Mobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Both experimental and control groups will receive standard care physiotherapy for low back pain according to the evidence presented in the study of Delitto et al. The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform exercise regularly. The therapist will treat the participants once a week for a 5-week period, each session will last 40 minutes. Besides the standard care, the therapist will perform cardia mobilization, pylori mobilization, Oddi's sphincter mobilization,duodenum-jejunum valve mobilization, ileocecal valve mobilization, global technique for the liver, global hemodynamic technique. Each technique will last 1 minutes, with the two last ones repeated 10 times.The placebo intervention involves light touch at the same regions of the techniques as above, and no intention on the part of the therapist to impart any therapeutic technique.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Visceral Manipulation