Online Pilates in Individuals With Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of the Pilates method, performed online, in individuals with chronic low back pain. This is a randomized controlled trial consisting of two arms.

Detailed Description
-----------------
Low back pain is one of the main causes of disability in the world, and physical inactivity is associated with its development. In this sense, Pilates can be used both in the treatment and preventively for this symptomatology. Thus, the aim of this study is to evaluate the effects of the Pilates method, performed online, in individuals with chronic low back pain. This is a randomized controlled trial involving men and women between 18 and 60 years of age with a history of non-specific chronic low back pain and a minimum pain intensity equal to 3 points on the numeric pain scale. Research participants will perform a pre-intervention (EV1) and post-intervention (EV2) assessment, both online. Pain sensation, functional performance, kinesiophobia and perception of global change will be the outcomes evaluated through the following instruments: Numerical Pain Scale, Roland Morris Questionnaire, Tampa Scale for kinesiophobia and Patient Global Impression of Change Scale. Participants included in the study will be randomized into two groups with separate interventions, both lasting eight weeks: online Pilates group and control group. The control group will receive information about self-management of low back pain, pain education, and changes in lifestyle habits; the Pilates group, besides having access to the same information as the control group, will undergo 16 Pilates sessions performed online (2 times/week). The statistical analysis will be done through the independent t test and the Mann-whitney test to investigate the differences between the groups (Pilates online x control), while the paired t test and the Wilcoxon test will be applied to evaluate the effect of the time variable (Pre x Post), considering a significance level of 5%.

Official Title
-----------------
Effects of an Online Pilates Protocol in Individuals With Chronic Low Back Pain: Randomized Controlled Trial

Conditions
-----------------
Low Back Pain, Chronic Pain

Intervention / Treatment
-----------------
* Other: Pilates method
* Other: Pain education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women with a history of chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale. Exclusion Criteria: Symptoms related to serious pathologies (such as fever, changes in sensibility, weight loss, constant pain); Recent history of spinal fracture, cancer, inflammatory diseases, nerve root involvement, spinal pathologies (such as ankylosing spondylitis, herniated disc with radiculopathy, advanced osteoporosis, spondylolysis, spondylolisthesis); Central neurological diseases (such as Parkinson's and stroke), psychiatric (such as depression or schizophrenia); Autoimmune diseases; Orthopedic surgery in the last year; Severe cardiovascular diseases; Decompensated metabolic diseases; Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilates Group<br>Pilates method exercise program, performed online, 8 weeks long, twice a week + information on self-management and pain education once a week. | Other: Pilates method<br>* Individuals in the Pilates group will perform specific exercises online. There will be 16 sessions, lasting 60 minutes, with 10 minutes of warm-up, 30 to 40 minutes of exercises focusing on the trunk stabilizers muscles, and 10 minutes of cool-down with relaxation, stretching, or meditation. In addition, the individuals will have access to the same information of the control group.<br>|
| Active Comparator: Control Group<br>Information on self-management of low back pain, pain education, and changes in lifestyle habits once a week during 8 weeks. | Other: Pain education<br>* Individuals in the control group will receive information on self-management of low back pain, pain education, and changes in lifestyle habits once a week during 8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensation | Painful sensation measured by numerical pain rating scale (11 points scale) | Change from baseline in pain sensation at eight weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance associated to back pain | Functional performance associated with low back pain measured by Roland Morris Disability Questionnaire (24 items - more items is related to worse disability) | Change from baseline in functional performance at eight weeks after the intervention | 
| Kinesiophobia | Kinesiophobia measured by Tampa Scale of Kinesiophobia (17 to 68 points) | Change from baseline in kinesiophobia at eight weeks after the intervention | 
| Patient global impression of change | Patient global impression of change measured by a scale with seven points, where 1 is equal to no change or worse and 7 is much better | The Patient global impression of change after eight weeks of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, Exercise Movement Techniques, Exercise, Chronic Pain, Telerehabilitation