Using a Robot to Treat Non-specific Low Back Pain
Condition: Non-specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Non-specific low back pain (NSLBP) is a musculoskeletal syndrome whose main characteristic is
      the pain, which is focalized in the lumbar area of the spine, which cannot be attributed to a
      known cause (traumatism, systemic diseases, nerve root compression, etc). The treatment
      includes massage and rehabilitation techniques. Here the investigators want to test whether a
      robot (ADAMO) may help in improving current physiotherapy exercises in reducing back pain.
      NSLBP patients will be randomly assigned to two arms (robot versus control) and they will
      receive 10 massage sessions. Pain evaluation will be performed with the visual analogue scale
      (VAS) and the Oswestry disability index (ODI). The ODI will be performed by an independent
      physician blind to the treatment.
    

Detailed description: 
      Low back pain is defined as a musculoskeletal syndrome, or group of symptoms, whose main
      characteristic is the pain, which is focalized in the lumbar area of the spine. The diagnosis
      is rather easy since symptoms are very evident. When this pain cannot be attributed to a
      known cause (traumatism, systemic diseases, nerve root compression, etc), it is called
      non-specific low back pain (NSLBP), which may represent 90-95% of all cases of back pain.

      The treatment for this pathology has been collected in several clinical practice guidelines,
      with little differences among them. All of them recommend: i) maintaining physical activity
      as far as the pain allows; ii) pharmacological treatment (analgesics, non-steroidal
      anti-inflammatories, muscle relaxants); and iii) non-pharmacological measures (local heat,
      cognitive-behavior therapy, spinal manipulation, rehabilitation programs). Rehabilitation
      therapy, including different exercises, such as extensions, back workshops, and aquatic
      exercises, among others, provides excellent results in managing chronic back pain. In
      addition, physiotherapeutic massage constitutes the most common practice to treat back pain
      and is very effective in the short term, although it may not address the underlying causes.

      The main problem in reporting and measuring physiotherapeutic massage practices is that the
      massage is applied by different therapists, with different strength and intensity, which may
      vary from session to session. The use of massaging robotic devices should solve all these
      problems and several prototypes are already available.

      In this study, the efficiency of the new ADAMO robot system (https://adamorobot.com/) will be
      tested. ADAMO bases its operation on a computer program that controls the manipulator robot,
      which, and by means of cameras installed at its end, must find in each session the points of
      treatment in the patient previously defined by the health professional and apply the air at
      the necessary pressure. This pressure is generated by means of a compressed air nozzle
      integrated in a handpiece installed at the end of the robot.

      Forty-four patients suffering from NSLBP will be recruited after signing the informed consent
      and randomly assigned to one of two experimental arms: robot or control for 10 sessions. Pain
      evaluation will be performed with the Oswestry disability index (ODI), which will be applied
      before starting and at the end of the treatment, and the visual analogue scale (VAS) which
      will be applied after each session. The ODI will be performed by an independent physician
      blind to the treatment. Statistical analysis will be performed to compare both treatments.
    

Intervention name(s): ADAMO
Intervention type(s): Other
Intervention description(s): Physical therapy provided with or without the help of a robot
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Forty-four patients suffering from NSLBP will be recruited after signing the informed consent and randomly assigned to one of two experimental arms: physical therapy with or without the help of a robot for 10 sessions. Pain evaluation will be performed with the Oswestry disability index (ODI), which will be applied before starting and at the end of the treatment, and the visual analogue scale (VAS) which will be applied after each session. The ODI will be performed by an independent physician blind to the treatment. Statistical analysis will be performed to compare both treatments.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: back pain; massage; robot