Online Pilates in Individuals With Chronic Low Back Pain

October 14, 2022 updated by: Liane de Brito Macedo, Universidade Federal do Rio Grande do Norte

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates Group
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
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.
Active Comparator: Control Group
Information on self-management of low back pain, pain education, and changes in lifestyle habits once a week during 8 weeks.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain sensation
Time Frame: Change from baseline in pain sensation at eight weeks after the intervention
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional performance associated to back pain
Time Frame: 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)
Change from baseline in functional performance at eight weeks after the intervention
Kinesiophobia
Time Frame: Change from baseline in kinesiophobia at eight weeks after the intervention
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
Time Frame: 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
The Patient global impression of change after eight weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Rio Grande do Norte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LBPOP22-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings