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

U

University of Sao Paulo

Status

Completed

Conditions

Chronic Low Back Pain

Treatments

Other: Self-Management Education
Other: Pain Neuroscience Education

Study type

Interventional

Funder types

Other

Identifiers

NCT03714061
66674117.5.0000.5414

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Pain Neuroscience Education (PNE)
Experimental group
Description:
The PNE will be administered following Explaining Pain concepts (Butler and Moseley, 2013), initially contextualizing the importance of the program. The program will be administered as interactive workshops lasting 50 minutes. In addition, the participants were oriented to perform at home a group o motor control exercises during three weeks, twice a week.
Treatment:
Other: Pain Neuroscience Education
Self-Management Education (SME)
Active Comparator group
Description:
The SME education will be administered as an interactive workshop lasting 50 minutes. The program is based on the Back-book material (Roland et al, 2011), focusing on concepts targeting change of behavior and beliefs. In addition, the participants were oriented to perform at home a group o motor control exercises during three weeks, twice a week.
Treatment:
Other: Self-Management Education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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