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Effects of Pain Neuroscience Education in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pain neuroscience education + Exercise
Exercise
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Chronic pain, Fibromyalgia, Pain neuroscience education, Exercise

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pain neuroscience education + Exercise

    Exercise

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change from Baseline function at 1 month
    This outcome will be measured with the pain disability index (PDI)
    Change from Baseline pain at 1 month
    This outcome will be measured with the numerical pain rating scale (NRS)

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    February 2, 2017
    Last Updated
    May 2, 2017
    Sponsor
    University of Malaga
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03044067
    Brief Title
    Effects of Pain Neuroscience Education in Fibromyalgia
    Official Title
    The Effects of Pain Neuroscience Education Plus Exercise in the Management of Fibromyalgia: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2017 (Anticipated)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Malaga

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia
    Keywords
    Chronic pain, Fibromyalgia, Pain neuroscience education, Exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pain neuroscience education + Exercise
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Exercise
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Other
    Intervention Name(s)
    Pain neuroscience education + Exercise
    Intervention Description
    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
    Intervention Name(s)
    Exercise
    Intervention Description
    A session of exercise covers the activity, strength and endurance of lower and upper muscles of the extremities.
    Primary Outcome Measure Information:
    Title
    Change from Baseline function at 1 month
    Description
    This outcome will be measured with the pain disability index (PDI)
    Time Frame
    1 month
    Title
    Change from Baseline pain at 1 month
    Description
    This outcome will be measured with the numerical pain rating scale (NRS)
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Change from Baseline self-efficacy at 1 moths
    Description
    Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will be measure the patient's confidence in performing certain activities despite pain.
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Javier Matias Soto, PT
    Phone
    616375349
    Ext
    +34
    Email
    msjavi93@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alejandro Luque Suarez, PhD
    Email
    aluques@uma.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alejandro Luque Suarez, PhD
    Organizational Affiliation
    University of Malaga
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Pain Neuroscience Education in Fibromyalgia

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