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Pain Neuroscience Education in Chronic Musculoskeletal Pain

Primary Purpose

Chronic Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PNE+Physiotherapy
Physiotherapy
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Musculoskeletal Pain focused on measuring Education, Chronic pain, Musculoskeletal pain, Self-efficacy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UGC Las Lagunas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PNE+Physiotherapy

Physiotherapy

Arm Description

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.

Physiotherapy includes kinesitherapy and exercises.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2017
Last Updated
June 1, 2020
Sponsor
University of Malaga
Collaborators
Fundación Pública Andaluza Progreso y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT03100721
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga
Collaborators
Fundación Pública Andaluza Progreso y Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Musculoskeletal Pain
Keywords
Education, Chronic pain, Musculoskeletal pain, Self-efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PNE+Physiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Physiotherapy includes kinesitherapy and exercises.
Intervention Type
Behavioral
Intervention Name(s)
PNE+Physiotherapy
Intervention Description
Physiotherapy cover kinesitherapy and exercises techniques. Besides that it will be covered the understanding and acknowledgement about how pain is processed.
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy cover kinesitherapy and exercises techniques.
Primary Outcome Measure Information:
Title
Change from Baseline self-efficacy at 1 and 4 months
Description
This outcome will be measured with the Chronic Pain Self-Efficacy Scale
Time Frame
1 and 4 months
Secondary Outcome Measure Information:
Title
Change from Baseline pain and pain interference at 1 and 4 months
Description
This outcome will be measured with the Graded Chronic Pain Scale
Time Frame
1 and 4 months
Title
Change from Baseline analgesic medication at 1 and 4 months
Description
This outcome will be measured checking digital medical history
Time Frame
1 and 4 months
Other Pre-specified Outcome Measures:
Title
Change from Baseline pain knowledge at 1 and 4 months
Description
This outcome will be measured with the revised Neurophysiology of Pain Questionnaire
Time Frame
1 and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Luque Suarez, PhD
Organizational Affiliation
University of Malaga
Official's Role
Principal Investigator
Facility Information:
Facility Name
UGC Las Lagunas
City
Mijas Costa
State/Province
Málaga
ZIP/Postal Code
29650
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain Neuroscience Education in Chronic Musculoskeletal Pain

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