Effects of Pain Neuroscience Education in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03044067
• Other study ID #: UniversityMalaga
• Status: Not yet recruiting
• Phase: N/A
• First received: February 2, 2017
• Last updated: May 2, 2017
• Start date: September 2017
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: University of Malaga
• Contact: Javier Matias Soto, PT
• Phone: 616375349
• Email: msjavi93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline function at 1 month	This outcome will be measured with the pain disability index (PDI)	1 month
Primary	Change from Baseline pain at 1 month	This outcome will be measured with the numerical pain rating scale (NRS)	1 month
Secondary	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