NCT03992612

Efficacy of Psychological Therapy in Chronic Pain and Fibromyalgia

Efficacy of Mindfulness-based Pain Management in Patients With Chronic Pain With and Without Fibromyalgia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: University of the Basque Country (UPV/EHU) · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia
• Chronic Pain

Interventions

Type	Name	Description
OTHER	control group: usual medical care	The patients received usual medical care.
BEHAVIORAL	MBPM- Mindfulness-Based Pain Management	8 group session of maindfulness-based treatment to management pain

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-01-30
• Completion: 2021-06-30
• First posted: 2019-06-20
• Last updated: 2022-03-16

Locations

1 site across 1 country: Spain