Pain Neuroscience Education vs. Self-management Programs Associated With Movement Control Exercises for Chronic Low Back Pain: a Randomized Controlled Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Low Back Pain
- Sponsor
- University of Sao Paulo
- Enrollment
- 104
- Locations
- 2
- Primary Endpoint
- Pain intensity - Numerical Pain Rating Scale (NPRS)
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary aim of this study is to compare the effects of an exercise program based on movement control exercises associated with self-management advice (SME) or pain neuroscience education (PNE) on the outcomes of pain intensity and pain disability in patients with chronic non-specific low back pain (CLBP).
Detailed Description
Participants: One hundred and four volunteers (104) aged 18-50 years with chronic non-specific low back pain. Interventions: The volunteers will be randomized into two treatment groups: self-management education and movement control exercises or pain neuroscience education and exercises based on movement control exercises. Two workshops of 40 minutes each will be administered as education approach and the exercise program along 2 months ( and 12 sessions distributed over 2 months. Main outcome measures: Primary outcomes will include pain intensity and low back disability, and secondary outcomes will be pain catastrophizing, pain self-efficacy, kinesiophobia, exercise adherence and global perceived effect. These will be measured pre- and post-intervention and at the 1-month follow-up. Statistical analysis will be conducted following treatment intent principles, and treatment effects will be calculated using a mixed linear model, considering intervention groups as a factor and assessments over time as repeated measures.
Investigators
Thais Cristina Chaves
Professor PhD
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •(1) non-specific chronic low back pain with a mechanical constituent caused by certain postures, activities, and movements, in addition to having at least 3 months of pain and/or episodes for at least half the previous 6 days, located between T12 and the gluteal folds; (2) pain intensity scores greater than 2 and greater than 14% on the Oswestry Low Back Disability Index and (3) positive results in 2 or more of the 6 tests to determine movement control impairment.
Exclusion Criteria
- •(1) red flags such as tumors or neoplastic diseases in the spine, inflammatory diseases, infections, and fractures; (2) central and peripheral, psychiatric, rheumatologic, and cardiac neurological diseases; (3) acute and symptomatic radiculopathy, lumbar stenosis, and spondylolisthesis; (4) pregnant women; and (5) individuals submitted to physiotherapeutic treatment during the last 6 months. Finally, volunteers will be advised about the non-use of pain medications 24 hours before the evaluations.
Outcomes
Primary Outcomes
Pain intensity - Numerical Pain Rating Scale (NPRS)
Time Frame: Immediately after and at 1-month follow-up
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". 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.
Low Back Pain Disability
Time Frame: Immediately after and at 1-month follow-up
The Brazilian Portuguese version of Oswestry Disability Index (ODI) will be used to assess low back pain related disability. This instrument consists of 10 items, each of which has six response options. The total score will be calculated by summing up all the points, with the largest possible sum being 50. This sum will be transformed into a percentage by multiplying it by two. Previous research has found that ODI showed responsiveness to change for patients with CLBP, with MCID of 8 points.
Secondary Outcomes
- Exercise Adherence(at the beginning of following session, immediately after and at 1-month follow-up)
- Pain Catastrophizing(Immediately after and at 1-month follow-up)
- Fear Avoidance Beliefs(Immediately after and at 1-month follow-up)
- Pain Self-Efficacy(Immediately after and at 1-month follow-up)
- Global Perceived Effect(Immediately after and at 1-month follow-up)