Effects of Pain Neuroscience Education in Fibromyalgia

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03044067

Enrollment

Registered

2017-02-06

Start date

2017-09-30

Completion date

2017-12-31

Last updated

2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Chronic pain, Fibromyalgia, Pain neuroscience education, Exercise

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.

Interventions

OTHERPain 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.

OTHERExercise

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Contacts

Primary ContactJavier Matias Soto, PT

msjavi93@gmail.com616375349

Backup ContactAlejandro Luque Suarez, PhD

aluques@uma.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026