Pain Neuroscience Education in Chronic Musculoskeletal Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Musculoskeletal Pain
• Intervention / Treatment: Behavioral: PNE+Physiotherapy; Procedure: Physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga
    • Mijas Costa, Málaga, Spain, 29650
      • UGC Las Lagunas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline self-efficacy at 1 and 4 months	This outcome will be measured with the Chronic Pain Self-Efficacy Scale	1 and 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline pain and pain interference at 1 and 4 months	This outcome will be measured with the Graded Chronic Pain Scale	1 and 4 months
Change from Baseline analgesic medication at 1 and 4 months	This outcome will be measured checking digital medical history	1 and 4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline pain knowledge at 1 and 4 months	This outcome will be measured with the revised Neurophysiology of Pain Questionnaire	1 and 4 months

Collaborators and Investigators

• Sponsor: University of Malaga
• Collaborators: Fundación Pública Andaluza Progreso y Salud

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): January 22, 2020
• Study Completion (Actual): January 22, 2020

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Chronic pain; Education; Self-efficacy; Musculoskeletal pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: PNE in MSK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No