Low back pain
Conditions
Interventions
This is a type 1 hybrid effectiveness/implementation trial, including a randomized controlled study with an economic evaluation of two arms: an experimental group (Pilates method) and a control group
E02.779.474
Sponsors
Universidade Federal de Minas Gerais
Pró-Reitoria de Pesquisa da Universidade Federal de Minas Gerais
Eligibility
Inclusion criteria
Inclusion criteria: Clinical diagnosis according to the criteria of the United Kingdom Parkinson’s Disease Society Brain Bank; non specific low back pain lasting for more than three months; pain intensity of at least three points on Numerical Pain Rating Scale, able to read and understand Portuguese; stable use of antiparkinsonian medication; preserved cognitive function; ability to walk independently; both sexes; no age restrictions
Exclusion criteria
Exclusion criteria: Diagnosis of other neurological and psychiatric diseases; history of trauma; nerve root compression; fracture; cancer; infection; or spinal surgery; participation in Pilates or physiotherapy sessions for treating low back pain within the last three months; visual or hearing impairments; any contraindication to exercise; post operative complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes of this study will be pain intensity measured by the Numerical Pain Rating Scale (NPRS) and disability measured by the Roland-Morris Disability Questionnaire (RMDQ) at baseline, immediately after the end of intervention (i.e., 3 months follow-up), and at the 6-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to reduce pain intensity, with the greatest effect on the musculoskeletal pain domain, as assessed by the King's Parkinson's Disease Pain Scale (KPPS), at baseline, immediately after the end of intervention (i.e., 3 months follow-up), and at the 6-month follow-up.;It is expected to reduce fatigue intensity measured by the Fatigue Severity Scale (FSS) at baseline, immediately after the end of intervention (i.e., 3 months follow-up), and at the 6-month follow-up.;It is expected to reduce depressive symptoms measured by the Beck Depression Inventory (BDI) at baseline, immediately after the end of intervention (i.e., 3 months follow-up), and at the 6-month follow-up.;It is expected to improve the perception of quality of life measured by the 39-Item Parkinson’s Disease Questionnaire (PDQ-39) and by the EQ-5D 3-Level Scale (EQ-5D-3L), at baseline, immediately after the end of intervention (i.e., 3 months follow-up), and at the 6-month follow-up. | — |
Countries
Brazil
Contacts
Public ContactPaula Scalzo
Universidade Federal de Minas Gerais
Outcome results
None listed