Online Pilates in Individuals With Chronic Low Back Pain

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Low Back Pain
• Interventions: Other: Pain education; Other: Pilates method

• Registration Number: NCT05578365
• Lead Sponsor: Universidade Federal do Rio Grande do Norte

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%.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-13
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18
• Study Start: 2022-10-31
• Primary Completion: 2023-03
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Pain education	Information on self-management of low back pain, pain education, and changes in lifestyle habits once a week during 8 weeks.
Pilates Group	Pilates method	Pilates method exercise program, performed online, 8 weeks long, twice a week + information on self-management and pain education once a week.

Primary Outcome Measures

Name	Time	Method
Pain sensation	Change from baseline in pain sensation at eight weeks after the intervention	Painful sensation measured by numerical pain rating scale (11 points scale)

Secondary Outcome Measures

Name	Time	Method
Functional performance associated to back pain	Change from baseline in functional performance at eight weeks after the intervention	Functional performance associated with low back pain measured by Roland Morris Disability Questionnaire (24 items - more items is related to worse disability)
Kinesiophobia	Change from baseline in kinesiophobia at eight weeks after the intervention	Kinesiophobia measured by Tampa Scale of Kinesiophobia (17 to 68 points)
Patient global impression of change	The Patient global impression of change after eight weeks of intervention	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