Clinical Trials Directory

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UnknownNCT03778970

Pain Education vs. Self-management Associated With Movement Control Exercises for Chronic Low Back Pain

Pain Neuroscience Education vs. Self-management Programs Associated With Movement Control Exercises for Chronic Low Back Pain: a Randomized Controlled Clinical Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
104 (estimated)
Sponsor
University of Sao Paulo · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPain Neuroscience EducationPain neuroscience education (2 sessions during 40 minutes) administered by an interactive workshop
OTHERSelf-Management EducationA self-management education (2 sessions during 40 minutes) administered by an interactive workshop
OTHERMovement Control ExercisesEight sessions of movement control exercises (30 minutes each) + advice to perform the exercises at home twice a week.

Timeline

Start date
2019-01-20
Primary completion
2020-12-30
Completion
2021-01-30
First posted
2018-12-19
Last updated
2019-02-28

Locations

2 sites across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03778970. Inclusion in this directory is not an endorsement.