Clinical trial NCT05578365: Online Pilates in Individuals With Chronic Low Back Pain
Official title: Effects of an Online Pilates Protocol in Individuals With Chronic Low Back Pain: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Chronic Pain
Keywords: low back pain
Exercise Movement Techniques
Exercise
Chronic Pain
Telerehabilitation
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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.

Primary outcomes:
measure: Pain sensation
timeFrame: Change from baseline in pain sensation at eight weeks after the intervention
Secondary outcomes:
measure: Functional performance associated to back pain
timeFrame: Change from baseline in functional performance at eight weeks after the intervention
measure: Kinesiophobia
timeFrame: Change from baseline in kinesiophobia at eight weeks after the intervention
measure: Patient global impression of change
timeFrame: The Patient global impression of change after eight weeks of intervention
Other outcomes:
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