Clinical trial NCT03778970: Pain Education vs. Self-management Associated With Movement Control Exercises for Chronic Low Back Pain
Official title: Pain Neuroscience Education vs. Self-management Programs Associated With Movement Control Exercises for Chronic Low Back Pain: a Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial, superiority trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity - Numerical Pain Rating Scale (NPRS)
timeFrame: Immediately after and at 1-month follow-up
measure: Low Back Pain Disability
timeFrame: Immediately after and at 1-month follow-up
Secondary outcomes:
measure: Pain Catastrophizing
timeFrame: Immediately after and at 1-month follow-up
measure: Pain Self-Efficacy
timeFrame: Immediately after and at 1-month follow-up
measure: Fear Avoidance Beliefs
timeFrame: Immediately after and at 1-month follow-up
measure: Exercise Adherence
timeFrame: at the beginning of following session, immediately after and at 1-month follow-up
measure: Global Perceived Effect
timeFrame: Immediately after and at 1-month follow-up
Other outcomes:
Locations:
city: Jacarezinho
country: Brazil
facility: Physical Therapy Clinic
state: Paraná
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: STUDY_DIRECTOR
References: