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Trial record 92 of 560 for:    Recruiting, Not yet recruiting, Available Studies | Teaching

Pain Neuroscience Education in Chronic Musculoskeletal Pain

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ClinicalTrials.gov Identifier: NCT03100721
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Fundación Pública Andaluza Progreso y Salud
Information provided by (Responsible Party):
Alejandro Luque-Suarez, University of Malaga

Brief Summary:

Chronic musculoskeletal pain (CMP) is highly prevalent, disabling and with high socio-economic costs, with many negative effects on quality of life. CMP affects the ability to perform work, social, recreational and domestic tasks by changing the mood and concentration of this population that suffers.

In a study carried out in 2010, 17% of the Spanish population had experienced pain in the last month and according to the severity of symptoms 12% felt severe , 64% moderate and 24% mild pain. In this same study it is specified that 61% was due to back pain, 29% due to neck pain and 23% due to shoulder pain.

Pain neuroscience education (PNE) has been shown as an effective treatment strategy in increasing knowledge and understanding of neurobiology, neurophysiology and pain processing, modifying beliefs about it, improving patient skills and encouraging to the accomplishment of physical and social activities in different chronic pathologies.


Condition or disease Intervention/treatment Phase
Chronic Musculoskeletal Pain Behavioral: PNE+Physiotherapy Procedure: Physiotherapy Not Applicable

Detailed Description:
Study design and setting: The design of the present study will be a quasi-experimental study with 2 follow-ups (one month and four months after intervention) that will be performed between Apr 2018 and Apr 2020 in public health system in Malaga, Spain. The outcomes will be assessed at baseline (t0), one month (t1) and four months after the physiotherapy treatment begins (t2). Written informed consent will be acquired for all participants prior to their participation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Neuroscience Education as a Complement to Physiotherapy in Patients With Chronic Musculoskeletal Pain: a Quasi-experimental Study
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: PNE+Physiotherapy
Pain neuroscience education (PNE) 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 one time (at baseline). Physiotherapy includes kinesitherapy and exercises.
Behavioral: PNE+Physiotherapy
Physiotherapy cover kinesitherapy and exercises techniques. Besides that it will be covered the understanding and acknowledgement about how pain is processed.

Active Comparator: Physiotherapy
Physiotherapy includes kinesitherapy and exercises.
Procedure: Physiotherapy
Physiotherapy cover kinesitherapy and exercises techniques.




Primary Outcome Measures :
  1. Change from Baseline pain and function pain associated at 1 and 4 months [ Time Frame: 1 and 4 months ]
    This outcome will be measured with the Graded Chronic Pain Scale


Secondary Outcome Measures :
  1. Central pain sensitization at baseline [ Time Frame: Baseline ]
    This outcome will be measured with Algometer

  2. Change from Baseline self-efficacy at 1 and 4 months [ Time Frame: 1 and 4 months ]
    This outcome will be measured with the Chronic Pain Self-Efficacy Scale

  3. Patient Satisfaction at 1 month [ Time Frame: 1 month ]
    This outcome will be measured with the Instrument for Measuring Patient Satisfaction



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18-65 years
  • Diagnosis of Chronic Musculoskeletal Pain according to the ACCTION-APS Pain Taxonomy (AAPT)
  • Presenting pain in low back, neck, shoulder, knee, and hip regions

Exclusion Criteria:

  • Acute-subacute pain
  • Chronic non-musculoskeletal pain according to the AAPT
  • Systemic diseases: cardiovascular, neurological, psychiatric and/or cancer
  • Medical history of trauma or surgery in the last 6 months
  • Unable to understand spanish spoken and written

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): NCT03100721


Contacts
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Contact: Antonio Rondon Ramos, PT, MsC 600 142 611 ext +34 arondon@uma.es
Contact: Alejandro Luque Suarez, PhD 951 952 863 ext +34 aluques@uma.es

Locations
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Spain
UGC Las Lagunas Recruiting
Mijas Costa, Málaga, Spain, 29650
Contact: Antonio Rondón, PT    600 142 611 ext +34    arondon@uma.es   
Sponsors and Collaborators
University of Malaga
Fundación Pública Andaluza Progreso y Salud
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: NCT03100721     History of Changes
Other Study ID Numbers: PNE in MSK
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
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:
Education
Neuroscience
Chronic pain
Musculoskeletal pain
Primary care
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms