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CompletedNCT03100721Updated Jun 4, 2020

Pain Neuroscience Education in Chronic Musculoskeletal Pain

An interventional study of PNE+Physiotherapy and Physiotherapy in Chronic Musculoskeletal Pain, sponsored by University of Malaga. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by University of Malaga · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Musculoskeletal Pain

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Keywords

  • Education
  • Chronic pain
  • Musculoskeletal pain
  • Self-efficacy
03

In context

Musculoskeletal Pain

493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.

This study's enrollment of 100 is above the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

University of Malaga is the lead sponsor of 118 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • 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

  • Active comparator
    Physiotherapy

    Physiotherapy includes kinesitherapy and exercises.

    Procedure: Physiotherapy

Interventions

  • BehavioralPNE+Physiotherapy

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

  • ProcedurePhysiotherapy

    Physiotherapy cover kinesitherapy and exercises techniques.

06

What researchers measure

Primary outcomes

  1. Change from Baseline self-efficacy at 1 and 4 months

    This outcome will be measured with the Chronic Pain Self-Efficacy Scale

    Time frame: 1 and 4 months

Secondary outcomes

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

    This outcome will be measured with the Graded Chronic Pain Scale

    Time frame: 1 and 4 months

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

    This outcome will be measured checking digital medical history

    Time frame: 1 and 4 months

Other outcomes

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

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

    Time frame: 1 and 4 months

07

Study locations

1 site
  • UGC Las Lagunas
    Mijas Costa, Málaga 29650, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03100721
Lead sponsor
University of Malaga
Collaborators
Fundación Pública Andaluza Progreso y Salud
Responsible party
Alejandro Luque-Suarez (PhD, University of Malaga) — Principal investigator
First posted
Apr 4, 2017
Start date
Apr 4, 2018
Primary completion
Jan 22, 2020
Completion
Jan 22, 2020
Last update
Jun 4, 2020

Study contacts

Alejandro Luque Suarez, PhD
principal investigator · University of Malaga

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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