PRE Surgery reHABilitation for Spinal Stenosis
Condition: Low Back Pain; Rehabilitation; Physiotherapy
MeSH terms: Spinal Stenosis; Low Back Pain; Constriction, Pathologic
Study type: Interventional

Summary: 
      Lumbar spinal stenosis is a spinal disorder that affects mainly people over the age of 60.
      LSS is the most common reason to perform spinal surgery for people aged >65 years and have
      been shown to be superior to conservative treatment. Hitherto, studies on lumbar spinal
      stenosis are sparse with only 3 trials including approximately 300 patients. There is also a
      paucity in studies investigating if people with lumbar spinal stenosis improve their outcome
      following surgery undergoing a pre-surgery rehabilitation programme including physical
      fitness exercises, abdominal and back muscle strengthening and a core control approach.
    

Detailed description: 
      Lumbar spinal stenosis is a spinal disorder that affects mainly people over the age of 60.
      This age group with neurogenic claudication is expected to rise dramatically over the next 20
      years when an estimated 23-25 % of the population will be > 60 years. Lumbar spinal stenosis
      is the most common reason to perform spinal surgery for people aged >65 years and have been
      shown to be superior to conservative treatment. Conservative treatment post-operatively have
      recently been described in a Cochrane review to be of importance. Hitherto, studies on lumbar
      spinal stenosisare sparse with only 3 trials including approximately 300 patients. There is
      also a paucity in studies investigating if people with lumbar spinal stenosis improve their
      outcome following surgery undergoing a pre-surgery rehabilitation programme including
      physical fitness exercises, abdominal and back muscle strengthening and a core control
      approach.

      Aim: The aim of the current study was to evaluate a pre-surgery rehabilitation intervention
      for patients diagnosed with lumbar spinal stenosis found eligible for a decompression
      surgery. A further aim was to conduct a qualitative study to explore the experience of
      symptoms in relation to all-day-living and quality of life among those who have undergone a
      decompression surgery for lumbar spinal stenosis.

      Methods: Patients consecutively seeking or referred for orthopaedic surgery at Spine Clinic
      in Stockholm will, if found eligible and given their informed consent be randomized into two
      separate groups following a consultant visit to an orthopaedic surgeon; 1) A pre-habilitation
      program of 8 weeks before decompression surgery 2) Care as usual, that is information from
      physiotherapists 2 weeks before surgery and the advice to stay active. Those eligible for
      decompression surgery are patients aged 50-75 with pseudo-claudication in one or both legs
      and back pain (VAS>30), magnetic resonance camera with 1-2 adjacent stenotic segments (L3-S1)
      (area ≤75mm2), duration of symptoms >6 months.

      Both written and oral information of the study will be given and the patients will give their
      written consent. An independent physiotherapist blinded to patient assignment will
      sequentially number the envelopes containing intervention assignments according to a
      computer-generated randomization. Opaque and sealed envelopes will be opened in front of the
      participants at the end of the initial assessment visit. The main applicant will be
      responsible for data collection, to set up the program and educate included physiotherapists,
      to be responsible for analyses of data and for ethical application.

      For the secondary aim a strategic sample of patients from both groups following the surgery
      will be included to conduct semi-structured deep interviews to explore their experience of
      facilitators and barriers to every day life both before and after the surgery. The interviews
      will take place 3 months following the surgery. The collected data will be analysed according
      a content analysis with categories, sub categories and themes.
    

Intervention name(s): Supervised abdominal exercises and stationary biking
Intervention type(s): Other
Intervention description(s): Explain pain to the patients in order to minimize fear of movement
Other intervention name(s): Explain pain
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled study with two treatment arms; one with care as usual and the intervention group with prehab before surgery. This is a feasibility study to determine how many subjects who need to be included to be able to a obtain an estimate of variance in an outcome when an important difference between groups
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: prehabilitation; spinal stenosis; physiotherapy