Effect of Lumbar Stabilization Exercises and Circular Dances in Chronic Non Specific Low Back Pain

August 5, 2019 updated by: University of Sao Paulo General Hospital

Effect of Lumbar Stabilization Exercises and Circular Dances in Chronic Non Specific Low Back Pain in Middle-aged Women: Single-blind Randomized Clinical Trial

Supervised exercises are the first line therapy for patients with chronic low back pain. The lumbar segmental stabilization (LSE) is a specific training for the muscles of the lumbar spine, which aims to improve neuromuscular control, strength and endurance of the muscles that promotes stability to the spine. The circular dance (CD) belongs to the group of complementary and integrative practices entered in Public Health Care in Brazil, and has been used to improve several aspects related to physical and mental states such as flexibility, posture, strength and muscular endurance, awareness or scheme body, pain control and strains. There are few studies evaluating the circular dance effect on back pain. The aim of this study is to compare the effects of lumbar stabilization exercises and circular dance for improvement in non specific low back pain in middle-aged women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

OBJECTIVE: To compare the effect of CD with ESL exercises on pain and functional disability in women with nonspecific chronic low back pain (DLCI). METHOD: Thirty-eight women, aged 35-60 years, were randomly assigned to two groups: 1) Circular Dance group (gDC); 2) Lumbar Stabilization Exercise group (gESL). The primary clinical outcomes were pain, assessed using the Numerical Pain Scale and functional disability by the Roland Morris Disability Questionnaire and the secondary outcomes were: Depression assessed by the Beck Depression Inventory; Anxiety by the Numerical Anxiety Scale; Global Perception with the Global Effect Perception Scale, Signs and Symptoms of Adverse Effects analyzed by the Collective Subject Discourse and Quality of Life method using the Short-Form Health Survey Questionnaire (SF-36). The groups were treated twice a week for 60 minutes for 8 weeks totaling 16 sessions. Each participant was assessed before and after treatment and at follow-up 12 and 24 weeks.

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 (Actual)

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.
38

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraíba
      • João Pessoa, Paraíba, Brazil, 58051900
        • Juerila Moreira Barreto

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

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnose of non specific low back pain for a period of three months without radiculopathy symptoms
  • Seek treatment

Exclusion Criteria:

  • Inflammatory disorders of the spine
  • Spinal tumors
  • Spine surgery
  • Unconsolidated fractures or malunion of the spine
  • Rheumatologic disease
  • Spondylolysis or spondylolisthesis
  • Patients who are in labor dispute
  • Patients undergoing physical therapy or drug treatment to opioid-based

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: Single

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: Lumbar Stabilization Exercise
There will be 16 sessions, twice a week, with 40-60 minutes each session. In this arm the participants will learn basic notions about anatomy and biomechanics and the lumbar stabilization technique. They will be evaluated by a pressure biofeedback in the first day that will be used in the training. The lumbar stabilization technique consists of three stages: cognitive, associated and automatic. The biofeedback is used in the first stage and it helps patients to do the best contraction of stabilization muscles in different levels of pressure. Then, in stage two the patients do the contraction without the use of biofeedback and in the last phase different exercises are associated with the contraction of stabilization muscles.
Other: Lumbar Stabilization Exercise
There will be 16 sessions, twice a week, with 40-60 minutes each session. In this arm the participants will learn basic notions about anatomy and biomechanics and the lumbar stabilization technique. They will be evaluated by a pressure biofeedback in the first day that will be used in the training. The lumbar stabilization technique consists of three stages: cognitive, associated and automatic. The biofeedback is used in the first stage and it helps patients to do the best contraction of stabilization muscles in different levels of pressure. Then, in stage two the patients do the contraction without the use of biofeedback and in the last phase different exercises are associated with the contraction of stabilization muscles.
Experimental: Circular Dance
There will be 16 sessions, twice a week, with 60 minutes each session. In this arm the participants will do the exercises in a group of 20 subjects. In every meeting there will be the follow stages: reception, reflection, warming/stretching, explanation about circular dance, choreography orientation, practice and finishing.
Other: Circular dance
There will be 16 sessions, twice a week, with 60 minutes each session. In this arm the participants will do the exercises in a group of 20 subjects. In every meeting there will be the follow stages: reception, reflection, warming/stretching, explanation about circular dance, choreography orientation, practice and finishing.

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
Change in pain through Pain visual analogue scale
Time Frame: Before the treatment and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment) and in every session (from the first session to the sixteen session), immediately after session
Scale with 11 centimeters is used for evaluate pain intensity
Before the treatment and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment) and in every session (from the first session to the sixteen session), immediately after session

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
Roland Morris Disability Questionnaire
Time Frame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
This questionnaire evaluate the functional disability provoked by Low back pain
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Global Perceived Effect Scale
Time Frame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
This scale evaluates the participant's perception of recovery from the treatment, comparing the symptoms at the beginning and at the end of treatment.
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Beck Depression Inventory
Time Frame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Composed of 21 items, this scale evaluates the intensity of symptoms and ranges from 0 to 3 and the higher the score, the greater the depressive symptoms.
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Visual analogue scale for anxiety
Time Frame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Scale of 11 points, whose value ¨0¨ in the left end indicates ¨ without anxiety¨ and the value ¨10¨ in the extreme right indicates "the worst perceived anxiety" in the last seven days
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Medical Outcomes Study 36 - Item Short - Form Health Survey
Time Frame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
This instrument evaluates the patient's perception of his quality of life in aspects related to functional capacity, physical aspects, pain, general health, vitality, social, emotional and mental health aspects.
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Symptoms and Adverse events or side effects
Time Frame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
During treatment, patients are asked about side effects resulting from the treatment performed.
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)

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.
University of Sao Paulo General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federal University of Paraíba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Raquel A Casarotto, PhD, University of Sao Paulo

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 (Actual)

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.
June 1, 2016

Primary Completion (Actual)

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.
July 1, 2018

Study Completion (Actual)

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.
January 1, 2019

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).
May 18, 2016

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.
June 15, 2016

First Posted (Estimate)

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.
June 21, 2016

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.
August 6, 2019

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.
August 5, 2019

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.
April 1, 2019

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.
  • ELSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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