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Effects of Pain Neuroscience Education in Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044067
Recruitment Status : Unknown
Verified February 2017 by Alejandro Luque-Suarez, University of Malaga.
Recruitment status was:  Not yet recruiting
First Posted : February 6, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Alejandro Luque-Suarez, University of Malaga

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Pain neuroscience education + Exercise Other: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Pain Neuroscience Education Plus Exercise in the Management of Fibromyalgia: A Randomized Controlled Trial
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from Baseline function at 1 month [ Time Frame: 1 month ]
    This outcome will be measured with the pain disability index (PDI)

  2. Change from Baseline pain at 1 month [ Time Frame: 1 month ]
    This outcome will be measured with the numerical pain rating scale (NRS)


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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044067


Contacts
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Contact: Javier Matias Soto, PT 616375349 ext +34 msjavi93@gmail.com
Contact: Alejandro Luque Suarez, PhD aluques@uma.es

Sponsors and Collaborators
University of Malaga
Investigators
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Principal Investigator: Alejandro Luque Suarez, PhD University of Malaga

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Responsible Party: Alejandro Luque-Suarez, PhD, University of Malaga
ClinicalTrials.gov Identifier: NCT03044067    
Other Study ID Numbers: UniversityMalaga
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandro Luque-Suarez, University of Malaga:
Chronic pain
Fibromyalgia
Pain neuroscience education
Exercise
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases