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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lumbar Stabilization Exercise
Circular dance
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Exercise, Dance Therapy, Physical Therapy

Eligibility Criteria

35 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Juerila Moreira Barreto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lumbar Stabilization Exercise

Circular Dance

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in pain through Pain visual analogue scale
Scale with 11 centimeters is used for evaluate pain intensity

Secondary Outcome Measures

Roland Morris Disability Questionnaire
This questionnaire evaluate the functional disability provoked by Low back pain
Global Perceived Effect Scale
This scale evaluates the participant's perception of recovery from the treatment, comparing the symptoms at the beginning and at the end of treatment.
Beck Depression Inventory
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.
Visual analogue scale for anxiety
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
Medical Outcomes Study 36 - Item Short - Form Health Survey
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.
Symptoms and Adverse events or side effects
During treatment, patients are asked about side effects resulting from the treatment performed.

Full Information

First Posted
May 18, 2016
Last Updated
August 5, 2019
Sponsor
University of Sao Paulo General Hospital
Collaborators
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT02807090
Brief Title
Effect of Lumbar Stabilization Exercises and Circular Dances in Chronic Non Specific Low Back Pain
Official Title
Effect of Lumbar Stabilization Exercises and Circular Dances in Chronic Non Specific Low Back Pain in Middle-aged Women: Single-blind Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Federal University of Paraíba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Exercise, Dance Therapy, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar Stabilization Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Circular Dance
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lumbar Stabilization Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Circular dance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain through Pain visual analogue scale
Description
Scale with 11 centimeters is used for evaluate pain intensity
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
Secondary Outcome Measure Information:
Title
Roland Morris Disability Questionnaire
Description
This questionnaire evaluate the functional disability provoked by Low back pain
Time Frame
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Title
Global Perceived Effect Scale
Description
This scale evaluates the participant's perception of recovery from the treatment, comparing the symptoms at the beginning and at the end of treatment.
Time Frame
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Title
Beck Depression Inventory
Description
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.
Time Frame
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Title
Visual analogue scale for anxiety
Description
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
Time Frame
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Title
Medical Outcomes Study 36 - Item Short - Form Health Survey
Description
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.
Time Frame
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Title
Symptoms and Adverse events or side effects
Description
During treatment, patients are asked about side effects resulting from the treatment performed.
Time Frame
Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel A Casarotto, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Juerila Moreira Barreto
City
João Pessoa
State/Province
Paraíba
ZIP/Postal Code
58051900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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