NCT03100721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

April 4, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

1.8 years

First QC Date

March 22, 2017

Last Update Submit

June 1, 2020

Conditions

Chronic Musculoskeletal Pain

Keywords

EducationChronic painMusculoskeletal painSelf-efficacy

Outcome Measures

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

    1 and 4 months

Secondary Outcomes (2)

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

    1 and 4 months

  • Change from Baseline analgesic medication at 1 and 4 months

    1 and 4 months

Other Outcomes (1)

  • Change from Baseline pain knowledge at 1 and 4 months

    1 and 4 months

Study Arms (2)

PNE+Physiotherapy

EXPERIMENTAL

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

ACTIVE COMPARATOR

Physiotherapy includes kinesitherapy and exercises.

Procedure: Physiotherapy

Interventions

PNE+PhysiotherapyBEHAVIORAL

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

PNE+Physiotherapy
PhysiotherapyPROCEDURE

Physiotherapy cover kinesitherapy and exercises techniques.

Physiotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UGC Las Lagunas

Mijas Costa, Málaga, 29650, Spain

Location

MeSH Terms

Conditions

Chronic PainMusculoskeletal Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Alejandro Luque Suarez, PhD

    University of Malaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 4, 2017

Study Start

April 4, 2018

Primary Completion

January 22, 2020

Study Completion

January 22, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)