Efficacy of Psychological Therapy in Chronic Pain and Fibromyalgia
Condition: Fibromyalgia; Chronic Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain
Study type: Interventional

Summary: 
      Today, one of the most important challenges of the health system is the attitude towards
      chronic disorders. That implies changing from a health structure established for the
      treatment of acute diseases to a continued care system.

      In this sense, the approach of chronic pain, of non-oncological origin, supposes an important
      care challenge, to which this project wishes to respond.

      Chronic pain affects one of every Europeans (19%), and has a prevalence of 11% in Spain,
      being one of the most important causes of medical consultation and is associated with high
      personal, social and economic costs. For example, in 2017 it was calculated that it has an
      economic impact of between 1.7 and 2.1% of Spain's GDP.

      Referred to the psychological consequences of the disease, it has been found that 42% of
      people who have chronic pain suffer insomnia, a 40% anxiety, and 24% depressive symptoms.
      Hence the importance of implementing evidence-based psychological treatments along with their
      treatment as usual The main objective is comparing the efficacy of mindfulness-based pain
      management (MBPM), together with the usual medical treatment, in patients diagnosed with
      chronic pain, with and without comorbid fibromyalgia.

      Specific objectives are:

        1. To study the sociodemographic and clinical profile of patients with chronic pain, with
           and without fibromyalgia.

        2. Define the characteristics of patients who are in the different stages of the disease:
           stage 1 (less than two years since diagnosis); stage 2 (between 2 and 4 years); stage 3
           (between 5 and 8 years), and stage 4 (more than 8 years).

        3. Check the effectiveness of psychological therapies MBPM depending on the presence of
           fibromyalgia.

        4. Check the effectiveness of the psychological treatment in function of the stage of the
           disease.

      Method:

      A quasi-experimental design of two groups will be used. Patients will be assigned to
      experimental group: 50 subjects will receive MBPM and control group 40 subjects, 3-months
      wait list, after which time they will also receive MBPM.

      All the participants will be assessed in the baseline; at the end of the treatment; and in
      the 1, 3, 6 and 12 months follow-ups. Group 2 (waiting list) will be assessed in the
      baseline, and re-assessed before starting the treatment; at the end of the psychological
      therapy; and in the 1, 3, 6 and 12 months follow-ups.
    

Detailed description: 
      The objetive of this research are the study of efficacy in chronic pain and fybromyalgia of
      mindfulness therapy.
    

Intervention name(s): control group: usual medical care; MBPM- Mindfulness-Based Pain Management
Intervention type(s): Other; Behavioral
Intervention description(s): The patients received usual medical care.; 8 group session of maindfulness-based treatment to management pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibromyalgia; Chronic Pain; Psychological Treatment; Effectiveness; MBPM