Online Pilates in Individuals With Chronic Low Back Pain
Primary Purpose
Low Back Pain, Chronic Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pilates method
Pain education
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, Exercise Movement Techniques, Exercise, Chronic Pain, Telerehabilitation
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pilates Group
Control Group
Arm Description
Pilates method exercise program, performed online, 8 weeks long, twice a week + information on self-management and pain education once a week.
Information on self-management of low back pain, pain education, and changes in lifestyle habits once a week during 8 weeks.
Outcomes
Primary Outcome Measures
Pain sensation
Painful sensation measured by numerical pain rating scale (11 points scale)
Secondary Outcome Measures
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)
Kinesiophobia
Kinesiophobia measured by Tampa Scale of Kinesiophobia (17 to 68 points)
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
Full Information
NCT ID
NCT05578365
First Posted
October 10, 2022
Last Updated
October 14, 2022
Sponsor
Universidade Federal do Rio Grande do Norte
1. Study Identification
Unique Protocol Identification Number
NCT05578365
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Pain
Keywords
low back pain, Exercise Movement Techniques, Exercise, Chronic Pain, Telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pilates Group
Arm Type
Experimental
Arm Description
Pilates method exercise program, performed online, 8 weeks long, twice a week + information on self-management and pain education once a week.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Information on self-management of low back pain, pain education, and changes in lifestyle habits once a week during 8 weeks.
Intervention Type
Other
Intervention Name(s)
Pilates method
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pain education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain sensation
Description
Painful sensation measured by numerical pain rating scale (11 points scale)
Time Frame
Change from baseline in pain sensation at eight weeks after the intervention
Secondary Outcome Measure Information:
Title
Functional performance associated to back pain
Description
Functional performance associated with low back pain measured by Roland Morris Disability Questionnaire (24 items - more items is related to worse disability)
Time Frame
Change from baseline in functional performance at eight weeks after the intervention
Title
Kinesiophobia
Description
Kinesiophobia measured by Tampa Scale of Kinesiophobia (17 to 68 points)
Time Frame
Change from baseline in kinesiophobia at eight weeks after the intervention
Title
Patient global impression of change
Description
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
Time Frame
The Patient global impression of change after eight weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liane B Macedo, PhD
Phone
+55 (84) 3342-2287
Email
liane.macedo@ufrn.br
12. IPD Sharing Statement
Plan to Share IPD
No
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Online Pilates in Individuals With Chronic Low Back Pain
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