Clinical trial NCT03714061: Effects of Pain Neuroscience Education vs. Self-Management Education in Low Back Pain
Official title: Effects of Pain Neuroscience Education Compared to Self-Management Education for Patients With Chronic Low Back Pain: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind, randomized clinical trial, controlled
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 60 years;
2. Medical diagnosis of nonspecific CLBP in the last 3 months and/or pain at least half of the days in the past 6 months, that is located between T12 and the gluteal folds;
3. Pain intensity equal to or greater than three on numerical pain rating scale (NPRS)
4. Score greater than 14% on the Oswestry Disability Index and
5. Acceptable cognitive function assessed by Mini-Mental examination.

Exclusion Criteria:

1. red flags indicative of systemic involvement;
2. neurological symptoms, psychiatric, rheumatologic and cardiac diseases;
3. active radiculopathy;
4. lumbar stenosis;
5. spondylolisthesis;
6. history of spinal surgeries;
7. pregnancy;
8. previous physical therapy for low back in the past year

Primary outcomes:
measure: Pain intensity - Numerical Pain Rating Scale (NPRS)
timeFrame: At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment
measure: Pain catastrophizing - Pain Catastrophizing Scale
timeFrame: At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment
measure: Pain Self-Efficacy
timeFrame: At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment
Secondary outcomes:
measure: Low Back Pain Disability - Oswestry Disability Index
timeFrame: At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment
measure: Fear avoidance beliefs - The fear avoidance beliefs questionnaire (FABQ)
timeFrame: At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment
measure: Global Perceived Effect
timeFrame: 2 weeks after the initial assessment
measure: Anxiety and Depression - Hospital Anxiety and Depression Scale
timeFrame: At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment
measure: Exercise Adherence - Exercise Adherence Rating Scale
timeFrame: At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of Sao Paulo
state: São Paulo
Study officials:
affiliation: Professor - Ribeirão Preto Medical School - University of São Paulo
name: Thais Chaves, PhD
role: PRINCIPAL_INVESTIGATOR
References: