Effects of Pain Neuroscience Education in Fibromyalgia

The Effects of Pain Neuroscience Education Plus Exercise in the Management of Fibromyalgia: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Pain neuroscience education + Exercise; Other: Exercise

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Pain neuroscience education + Exercise; A session of Pain neuroscience education + Exercise covers the activity, strength and endurance of lower and upper muscles of the extremities. Besides that it will be covered the understanding and acknowledgement about how pain is processed.
Active Comparator: 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.	Other: Exercise; A session of exercise covers the activity, strength and endurance of lower and upper muscles of the extremities.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Malaga

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Chronic pain; Fibromyalgia; Pain neuroscience education
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: UniversityMalaga

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No