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

NCT03714061 | Completed

• 1 other identifier: 66674117.5.0000.5414
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (3)

• Pain intensity - Numerical Pain Rating Scale (NPRS)

  The NPRS used to assess pain intensity in this trial will consist in a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable" (Costa et al, 2008). Previous research has found the NPRS to be responsive to change, with a minimum clinically important difference (MCID) of 2.4 among patients with CLBP receiving exercise or education (Maughan and Lewis, 2010).

  At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment

• Pain catastrophizing - Pain Catastrophizing Scale

  The PCS translated and validated to Brazilian Portuguese by Sehn et al. (2012) will be used. The scale is composed of 13 items staggered on 6-point ordinal scale (0-5). The total score is the sum of the items divided by the number of items answered, with the minimum score being 0 and the maximum being 5 for each item. Higher scores indicated a greater presence of catastrophizing thoughts. The total score of the scale could vary between 0 and 52 points. A recent systematic review found that catastrophizing to be associated with pain and disability at follow-up in CLBP patients (Wertli et al, 2014).

  At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment

• Pain Self-Efficacy

  Study participants will be evaluated on self-efficacy related to chronic pain, which can be defined as an individual's confidence he/she can successfully produce desirable results related to living with chronic pain. The PSES has 10 items which are rated on a 7-point ordinal scale (ranging from 0: "not at all confident" to 6: "completely confident"). The maximum score is 60 and higher the score, higher the level of self-confidence of the participant to self-manage their pain. It was adapted and validated to Brazilian Portuguese (Sarda et al, 2007). Previous research showed an effect on self-efficacy using a PNE intervention based on metaphors compared to an intervention using cognitive-behavioral concepts (Gallager et al, 2013).

  At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment

Secondary Outcomes (5)

• Low Back Pain Disability - Oswestry Disability Index

  At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment

• Fear avoidance beliefs - The fear avoidance beliefs questionnaire (FABQ)

  At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment

• Global Perceived Effect

  2 weeks after the initial assessment

• Anxiety and Depression - Hospital Anxiety and Depression Scale

  At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment

• Exercise Adherence - Exercise Adherence Rating Scale

  At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment

Study Arms (2)

Pain Neuroscience Education (PNE)

EXPERIMENTAL

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.

Other: Pain Neuroscience Education

Self-Management Education (SME)

ACTIVE COMPARATOR

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.

Other: Self-Management Education

Interventions

Pain Neuroscience Education OTHER

The 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.

Pain Neuroscience Education (PNE)

Self-Management Education OTHER

Concepts 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.

Self-Management Education (SME)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 60 years;
• 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;
• Pain intensity equal to or greater than three on numerical pain rating scale (NPRS)
• Score greater than 14% on the Oswestry Disability Index and
• Acceptable cognitive function assessed by Mini-Mental examination.

You may not qualify if:

• red flags indicative of systemic involvement;
• neurological symptoms, psychiatric, rheumatologic and cardiac diseases;
• active radiculopathy;
• lumbar stenosis;
• spondylolisthesis;
• history of spinal surgeries;
• pregnancy;
• previous physical therapy for low back in the past year

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Study Officials

• Thais Chaves, PhD

  Professor - Ribeirão Preto Medical School - University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor PhD

Model Details: Single blind, randomized clinical trial, controlled

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: December 20, 2018
• Primary Completion: October 30, 2019
• Study Completion: November 30, 2019
• Last Updated: August 18, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)