The Effects of Pain Neuroscience Education Plus Exercise in the Management of Fibromyalgia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Malaga
- Enrollment
- 24
- Primary Endpoint
- Change from Baseline function at 1 month
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Pain neuroscience education + Exercise (Other)
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.
Intervention: Exercise (Other)
Outcomes
Primary Outcomes
Change from Baseline function at 1 month
Time Frame: 1 month
This outcome will be measured with the pain disability index (PDI)
Change from Baseline pain at 1 month
Time Frame: 1 month
This outcome will be measured with the numerical pain rating scale (NRS)
Secondary Outcomes
- Change from Baseline self-efficacy at 1 moths(1 month)
Investigators
Alejandro Luque-Suarez
PhD
University of Malaga