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

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ClinicalTrials.gov Identifier: NCT02807090
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
Federal University of Paraíba
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Lumbar Stabilization Exercise Other: Circular dance Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : July 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  1. 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 sixteenth session), immediately after session ]

Secondary Outcome Measures :
  1. Roland Morris Disability Questionnaire [ Time Frame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment) ]
  2. Global Perceived Effect Scale [ Time Frame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment) ]
  3. Beck Depression Inventory [ Time Frame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment) ]
  4. Visual analogue scale for anxiety [ Time Frame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment) ]
  5. 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) ]
  6. 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) ]


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807090


Contacts
Contact: Raquel A Casarotto, PhD +551130918424 racasaro@usp.br
Contact: Juerila M Barreto, Ms +5583981151313 juerila@gmail.com

Locations
Brazil
Juerila Moreira Barreto Recruiting
João Pessoa, Paraíba, Brazil, 58051900
Contact: Juerila Barreto, Ms    +55(83)981151313    juerila@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Federal University of Paraíba
Investigators
Study Director: Raquel A Casarotto, PhD University of São Paulo

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02807090     History of Changes
Other Study ID Numbers: ELSE
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Sao Paulo General Hospital:
Low Back Pain
Exercise
Dance Therapy
Physical Therapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms