Effects of Pain Neuroscience Education in Fibromyalgia

NCT ID: NCT03044067

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Pain neuroscience education + Exercise

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

A session of exercise covers the activity, strength and endurance of lower and upper muscles of the extremities.

Interventions

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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.

Intervention Type OTHER

Exercise

A session of exercise covers the activity, strength and endurance of lower and upper muscles of the extremities.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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Alejandro Luque-Suarez

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alejandro Luque Suarez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Central Contacts

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Javier Matias Soto, PT

Role: CONTACT

616375349 ext. +34

Alejandro Luque Suarez, PhD

Role: CONTACT

Other Identifiers

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UniversityMalaga

Identifier Type: -

Identifier Source: org_study_id

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