Efficacy of Psychological Therapy in Chronic Pain and Fibromyalgia

NCT03992612 | Completed

• 1 other identifier: PI2018162
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 1.To study the sociodemographic and clinical profile of patients with chronic pain, with and without fibromyalgia.
2. 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. 3.Check the effectiveness of psychological therapies MBPM depending on the presence of fibromyalgia.
4. 4.Check the effectiveness of the psychological treatment in function of the stage of the disease.

Conditions

Fibromyalgia; Chronic Pain

Keywords

Fibromyalgia; Chronic Pain; Psychological Treatment; Effectiveness; MBPM

Outcome Measures

Primary Outcomes (1)

• Change in Lattinen Index- IL

  It is a scale with five items to assess variables associated with pain: frequency, intensity, disability, drugs usage and sleep problems. These are assessed by a Likert scale of 0 to 4, in order to explain the discomfort that pain generates. (Gonzalez-Escada, 2012)

  base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)

Secondary Outcomes (8)

• Change in the Fibromyalgia Impact Questionnaire- FIQ

  base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)

• Change in the Listado de Sintomas Breve- LSB-50

  base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)

• Change in the Short Form 12 Health Survey- SF-12

  base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)

• Change in Cuestionario de afrontamiento del dolor- CAD-R

  base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)

• Change in Connor-Davison Resilience Scale- CDRISC

  base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)

Other Outcomes (1)

• Client Satisfaction Questionnaire

  end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)

Study Arms (2)

control group

OTHER

The patients received usual medical care.

Other: control group: usual medical care

MBPM- Minfulness- Based Pain Management

EXPERIMENTAL

Psychological intervention with 8 group sessions ( 8 -10 subjects) with a duration of 2 and a half hours per session and a weekly periodicity (total hours 1080). It is centered on training on the awareness of physical, cognitive and emotional sensations, and the attentional processes to become an observer of one's own thoughts and emotions. With the aim to provide greater flexibility to manage pain

Behavioral: MBPM- Mindfulness-Based Pain Management

Interventions

control group: usual medical care OTHER

The patients received usual medical care.

control group

MBPM- Mindfulness-Based Pain Management BEHAVIORAL

8 group session of maindfulness-based treatment to management pain

MBPM- Minfulness- Based Pain Management

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to complete the assessment protocol
• Suffer from chronic non-oncological pain, lasting longer than 6 months
• Not being receiving psychological treatment
• Sign the informed consent

You may not qualify if:

• Present a cognitive impairment, such as a dementia
• Present a diagnosis of a psychotic disease, bipolar disease or additive disease

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead

Study Sites (1)

University of Basque Country

San Sebastián, Guipuzcoa, 20018, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karmele Salaberria, PH.D

  University of Basque Country

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Lecturer in Psychology

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 20, 2019
• Study Start: June 1, 2019
• Primary Completion: January 30, 2021
• Study Completion: June 30, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

ES (1)