Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| OTHER | Pain Neuroscience Education | Pain neuroscience education (2 sessions during 40 minutes) administered by an interactive workshop |
| OTHER | Self-Management Education | A self-management education (2 sessions during 40 minutes) administered by an interactive workshop |
| OTHER | Movement Control Exercises | Eight 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.