- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02807090
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
38
Phase
- 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
-
-
Paraíba
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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.
Collaborators
Investigators
- 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)
June 1, 2016
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
May 18, 2016
First Submitted That Met QC Criteria
June 15, 2016
First Posted (Estimate)
June 21, 2016
Study Record Updates
Last Update Posted (Actual)
August 6, 2019
Last Update Submitted That Met QC Criteria
August 5, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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