Add-on Therapy for Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Study type: Interventional

Summary: 
      Rationale: Recent investigations suggest that, through certain concentration/meditation
      techniques, it is possible to modulate autonomic activity. The results of a recent randomized
      controlled trial investigating the "Wim Hof Method" have shown a direct biological effect on
      in-vivo cytokine production and are strongly encouraging the clinical evaluation of the
      technique's efficacy in immune-mediated inflammatory diseases.

      Objective: To investigate whether an add-on mindset & physical therapy program based on the
      "Wim Hof Method" can safely and efficaciously be applied in patients with active axial
      spondyloarthritis.

      Study design: Prospective open-label randomized controlled trial, safety and efficacy.

      Study population: Twenty-four patients with active axial spondyloarthritis between 18 and 45
      years of age.

      Intervention: A 30-day training program of add-on mindset and physical therapy for axial
      spondyloarthritis, using the methodology as designed and instructed by Wim Hof. It involves
      breathing techniques, training of mindset and concentration, and gradual cold exposure.

      Main study parameters/endpoints: Safety evaluation of the program is the primary aim of the
      study. Secondary endpoint is the modulation of serum CRP levels. Exploratory objectives
      include modulation of clinical disease activity (ASDAS), quality of life (SF-36, EQ-5D),
      depressive symptoms (HADS), and predictive role of generalized and specific outcome
      expectancies (EPQ-N, LOT-R, VAS scales).
    

Detailed description: 
      Axial spondyloarthritis (axSpA) is a common systemic autoinflammatory disease affecting
      approximately 7 in 1.000 individuals. Recent investigations suggest that, through certain
      concentration/meditation techniques, it is possible to modulate autonomic activity. The
      endotoxemia experiment in an individual (named Wim Hof) who used a self-created
      concentration/meditation technique is strongly supportive of these findings. The use of his
      technique - including breathing techniques, training of mindset and concentration, and
      gradual cold exposure - seemed to evoke a controlled stress response. This response was
      characterized by sympathetic nervous system activation and subsequent catecholamine/cortisol
      release, which seemed to attenuate the innate immune response. The remarkable results in the
      studied individual led to a randomised controlled trial of this technique at the Radboud UMC.
      Twenty-four healthy individuals were randomised to receive an instruction course of the
      technique or no instructions at all and subsequently underwent an endotoxemia experiment. The
      experiment involved the intravenous administration of very low doses of lipopolysaccharide
      and measuring the in-vivo cytokine response and clinical symptoms. The results of this study
      have shown a direct biological effect on in-vivo cytokine production and are strongly
      encouraging the evaluation of the technique's efficacy in clinical practice.

      The techniques of the Wim Hof Method have been modulated to a scientifically reproducible
      mindset & physical training program for add-on therapy of axSpA. Specifically, it has been
      adjusted for potential functional limitations of axSpA.

      Primary Objective: To investigate whether the add-on mindset & physical therapy program can
      safely be applied in patients with active axSpA using clinical safety parameters.

      Secondary Objective: To assess whether the add-on mindset & physical therapy program can
      modulate objective signs of inflammation in patients with active axSpA using serum biomarkers
      (e.g. CRP).

      Exploratory objective: To assess whether the add-on mindset & physical therapy program has an
      influence on the Ankylosing Spondylitis Disease Activity Score, quality of life, and
      depressive symptoms (HADS), and to explore the predictive role of generalized and specific
      outcome expectancies in patients with active axSpA
    

Intervention name(s): Add-on Therapy for Axial Spondyloarthritis
Intervention type(s): Behavioral
Other intervention name(s): Wim Hof Method
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment