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OpenTrials
Completed

NCT Number: NCT03100721

Pain Neuroscience Education in Chronic Musculoskeletal Pain

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.

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Key information

Conditions

Chronic Musculoskeletal Pain Chronic Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UGC Las Lagunas

Mijas Costa, Málaga, 29650, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-65 years
  • Chronic Musculoskeletal Pain according to the ACCTION-APS Pain Taxonomy (AAPT), included chronic axial musculoskeletal low back pain

Exclusion criteria

  • Chronic postoperative musculoskeletal pain and chronic musculoskeletal pain related to a traumatic injury six months before the beginning of the trial
  • Inability to provide written informed consent and/or complete questionnaires in Spanish.

Treatment and study plan

PNE+Physiotherapy

Behavioral

Physiotherapy cover kinesitherapy and exercises techniques. Besides that it will be covered the understanding and acknowledgement about how pain is processed.

physiotherapy

Procedure

Physiotherapy cover kinesitherapy and exercises techniques.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from Baseline pain and pain interference at 1 and 4 months

    Time frame: 1 and 4 months

    This outcome will be measured with the Graded Chronic Pain Scale

  2. Change from Baseline analgesic medication at 1 and 4 months

    Time frame: 1 and 4 months

    This outcome will be measured checking digital medical history

Other outcomes

  1. Change from Baseline pain knowledge at 1 and 4 months

    Time frame: 1 and 4 months

    This outcome will be measured with the revised Neurophysiology of Pain Questionnaire

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Collaborators

  • Fundación Pública Andaluza Progreso y Salud

Registry information

Official study title

Pain Neuroscience Education as a Complement to Physiotherapy in Patients With Chronic Musculoskeletal Pain: a Non-randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2017
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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