Clinical Trials Directory

Trials / Completed

CompletedNCT03714061

Effects of Pain Neuroscience Education vs. Self-Management Education in Low Back Pain

Effects of Pain Neuroscience Education Compared to Self-Management Education for Patients With Chronic Low Back Pain: a Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
University of Sao Paulo · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Chronic low back pain interventions may include exercises, manual therapy, health education, and pain education, strategies based on psychological or behavioral change approaches, as well as biopsychosocial interventions. Pain self-management programs basically aim to engage the participant in activities, stimulating the patient to be more active in life and live despite the pain. However, pain neuroscience education is a new approach recognized as therapeutic patient education (ETP) and is best described as a form of cognitive rather than behavioral therapy. However, there are few studies in the literature comparing those types pain education. Thus, the purpose of this study will be to compare the immediate effects of an educational program focused on Pain Neuroscience Education vs. Pain self-management educations for patients with chronic low back pain considering the outcomes of pain intensity, catastrophizing and pain self-efficacy.

Detailed description

There is some evidence in the literature suggesting better effects of pain neuroscience than "traditional pain education" based on pain self-management ("living despite the pain") and biomedical models. As the focus is based on cognitive change, pain neuroscience programs could be more effective than pain self-management programs, contributing to reconceptualize beliefs and minimize the level of threatening perceived by the brain. Gallagher et al (2013) reported effects of a pain neuroscience education program based on a book of metaphors compared to a pain self-management program (Back book) and reported greater immediate from pain neuroscience education on pain catastrophizing and pain knowledge. The hypothesis of this study is that a pain neuroscience education will show more effective results for pain intensity, catastrophizing and pain self-efficacy when compared to the pain self-management program in patients with CLBP. The purpose of this study will be to compare the immediate effects of an educational program focused on Pain Neuroscience Education vs. Pain self-management program for patients with chronic low back pain (CLBP) considering the outcomes of pain intensity, catastrophizing and pain self-efficacy. The investigators will recruit 108 with CLBP between 18 and 60 years and both genders. The sample size will be randomized into two arms: fifty participants will be submitted to Pain Neuroscience Education and the remaining fifty to Pain Self-Management education. Both interventions will be administered in one session (50 minutes). The programs will be showed as interactive workshops. Participants will be submitted to a brief initial assessment considering: pain intensity, fear of movement, anxiety and depression, catastrophizing, pain self-efficacy and global perceived effect.

Conditions

Interventions

TypeNameDescription
OTHERPain Neuroscience EducationThe PNE will be administered following Explaining Pain concepts, initially contextualizing the importance of the program, addressing concepts of neuroscience and pain, incorrect information about what is pain, how the brain responds to nociception in a variety of situations, and how an experience of danger can trigger or aggravate a state of pain, coexistence of several potential protection systems, central sensitization and how to promote behavioral change, abandoning incorrect beliefs, proposing graded activity exposure. In addition, participants were requested to perform a group of 7 exercises two times a week. In the day of the education session (second day), participants were again oriented on how to perform the exercises and invited to show the way they were executing them at home. In the first session, participants were trained on how to perform the abdominal bracing and oriented to repeat the maneuver in all exercises during the following three weeks.
OTHERSelf-Management EducationConcepts about pain, musculoskeletal pain, chronic pain and disability will be addressed. Participants will be guided on the process of chronic pain, associated suffering, conceptual model of fear-avoidance and clarified on avoidant and confronting profiles. In a third phase, strategies will be presented on how to deal with chronic pain, with advice on the harmful effects of restricting activities and the use of drug therapy in a careful way (Dupeyron et al, 2011). In addition, participants were requested to perform a group of 7 exercises two times a week. In the day of the education session (second day), participants were again oriented on how to perform the exercises (reinforcement) and invited to show the way they were executing them at home. In the first session, participants were trained on how to perform the abdominal bracing and oriented to repeat the maneuver in all exercises during the following three weeks.

Timeline

Start date
2018-12-20
Primary completion
2019-10-30
Completion
2019-11-30
First posted
2018-10-22
Last updated
2020-08-18

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03714061. Inclusion in this directory is not an endorsement.