Pain Education vs. Self-management Associated With Movement Control Exercises for Chronic Low Back Pain
NCT ID: NCT03778970
Last Updated: 2019-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
104 participants
INTERVENTIONAL
2019-01-20
2021-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pain Neuroscience Education + Exercises
The PNE will follow the principles established by Explain Pain, addressing reconceptualization of pain, emphasizing modern neuroscience concepts. The PNE workshop will last 40 minutes (2 sessions). The movement control exercises will consist of active exercises that address posture and control of movements which are impaired and trigger pain. The session will last approximately 30 minutes, starting with the execution of the coordination exercises in the control of movement with an intensity of 10 to 30 repetitions and then performing exercises for stretching in 3 series of 30 seconds. Finally, strengthening exercises in 3 sets of 15 repetitions will be implemented. The exercises will be administered 1 session/week (volunteers will be oriented to execute the same exercises at home twice a week). The volunteers will receive 8 sessions at the clinic.
Pain Neuroscience Education
Pain neuroscience education (2 sessions during 40 minutes) administered by an interactive workshop
Movement Control Exercises
Eight sessions of movement control exercises (30 minutes each) + advice to perform the exercises at home twice a week.
Self-Management Education + Exercises
The Self-Management Education (SME) strategy will be aligned with the "Back Book" concepts, focused on behavior change and encouraging participants to be active despite of the pain. The SME workshop will last 40 minutes (2 sessions). The movement control exercises will consist of active exercises that address posture and control of movements which are impaired and trigger pain. The session will last approximately 30 minutes, starting with the execution of the coordination exercises in the control of movement with an intensity of 10 to 30 repetitions and then performing exercises for stretching in 3 series of 30 seconds. Finally, strengthening exercises in 3 sets of 15 repetitions will be implemented. The exercises will be administered 1 session/week (volunteers will be oriented to execute the same exercises at home twice a week). The volunteers will receive 8 sessions at the clinic.
Self-Management Education
A self-management education (2 sessions during 40 minutes) administered by an interactive workshop
Movement Control Exercises
Eight sessions of movement control exercises (30 minutes each) + advice to perform the exercises at home twice a week.
Interventions
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Pain Neuroscience Education
Pain neuroscience education (2 sessions during 40 minutes) administered by an interactive workshop
Self-Management Education
A self-management education (2 sessions during 40 minutes) administered by an interactive workshop
Movement Control Exercises
Eight sessions of movement control exercises (30 minutes each) + advice to perform the exercises at home twice a week.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
50 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Thais Cristina Chaves
Professor PhD
Principal Investigators
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Thais Chaves, PhD
Role: STUDY_DIRECTOR
Professor - Ribeirão Preto Medical School - University of São Paulo
Locations
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Physical Therapy Clinic
Jacarezinho, Paraná, Brazil
University of Sao Paulo
Ribeirão Preto, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Tiago Del Antônio, PhD
Role: primary
Thais C Chaves, PhD
Role: primary
Tiago AG Del Antônio, MSc
Role: backup
Other Identifiers
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69172017.1.0000.5440
Identifier Type: -
Identifier Source: org_study_id