Effects of Pain Neuroscience Education in Fibromyalgia

Not Applicable

• Conditions: Fibromyalgia
• Interventions: Other: Exercise; Other: Pain neuroscience education + Exercise

• Registration Number: NCT03044067
• Lead Sponsor: University of Malaga

Brief Summary

Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a female to male ratio of 3:1) over 50 years of age with low education level and low socioeconomic status, living in rural areas. High direct medical costs and significant indirect costs of this condition can't be ignored.

Detailed Description

Study design and setting: The design of the present study will be a randomized controlled trial with 2 follow-ups (one week and one month after intervention) that will be performed between May 2017 and June 2017 in one private clinic in Malaga, Spain. The outcomes will be assessed at baseline (t1), one week after intervention (t2), and one moth after intervention (t3). Written informed consent will be acquired for all participants prior to their participation. The study will be implemented and reported in line with the CONSORT statement.

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-03
• Study First Posted: 2017-02-06
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03
• Study Start: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age between 18-70 years.
• Willing and able to participate
• Diagnosis of Fibromyalgia

Exclusion Criteria

• Systemic diseases
• Pain and function due to other rheumatic disorders such as: osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Exercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities. Participants will attend three appointments per week over three weeks. They will complete three sets of 10 repetitions, with the exercises progressed in difficulty at each appointment.
Pain neuroscience education + Exercise	Pain neuroscience education + Exercise	Pain neuroscience education can be defined as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. It will be applied three times (at baseline, one week and one month after intervention). Exercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities.

Primary Outcome Measures

Name	Time	Method
Change from Baseline function at 1 month	1 month	This outcome will be measured with the pain disability index (PDI)
Change from Baseline pain at 1 month	1 month	This outcome will be measured with the numerical pain rating scale (NRS)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline self-efficacy at 1 moths	1 month	Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will be measure the patient's confidence in performing certain activities despite pain.