Clinical trial NCT03100721: Pain Neuroscience Education in Chronic Musculoskeletal Pain
Official title: Pain Neuroscience Education as a Complement to Physiotherapy in Patients With Chronic Musculoskeletal Pain: a Non-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Keywords: Education
Chronic pain
Musculoskeletal pain
Self-efficacy
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Fundación Pública Andaluza Progreso y Salud
First posted: 2017-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline self-efficacy at 1 and 4 months
timeFrame: 1 and 4 months
Secondary outcomes:
measure: Change from Baseline pain and pain interference at 1 and 4 months
timeFrame: 1 and 4 months
measure: Change from Baseline analgesic medication at 1 and 4 months
timeFrame: 1 and 4 months
Other outcomes:
measure: Change from Baseline pain knowledge at 1 and 4 months
timeFrame: 1 and 4 months
Locations:
city: Mijas Costa
country: Spain
facility: UGC Las Lagunas
state: Málaga
Study officials:
affiliation: University of Malaga
name: Alejandro Luque Suarez, PhD
role: PRINCIPAL_INVESTIGATOR
References: