Online Pilates in Individuals With Chronic Low Back Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05578365
• Other study ID #: LBPOP22-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: April 2023

Study information

• Verified date: October 2022
• Source: Universidade Federal do Rio Grande do Norte
• Contact: Liane B Macedo, PhD
• Phone: +55 (84) 3342-2287
• Email: liane.macedo[@]ufrn.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: April 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Other:
• Pilates method
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.
• Pain education
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Kinesiophobia	Kinesiophobia measured by Tampa Scale of Kinesiophobia (17 to 68 points)	Change from baseline in kinesiophobia at eight weeks after the intervention
Secondary	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