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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03100721
Other study ID # PNE in MSK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 4, 2018
Est. completion date January 22, 2020

Study information

Verified date June 2020
Source University of Malaga
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 22, 2020
Est. primary completion date January 22, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain UGC Las Lagunas Mijas Costa Málaga

Sponsors (2)

Lead Sponsor Collaborator
University of Malaga Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 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
Secondary Change from Baseline analgesic medication at 1 and 4 months This outcome will be measured checking digital medical history 1 and 4 months
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