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Completed

NCT Number: NCT02807090

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

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.

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Key information

Conditions

Low Back Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Juerila Moreira Barreto

João Pessoa, Paraíba, 58051900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar Stabilization Exercise

Other

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.

Circular dance

Other

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 outcomes

  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 sixteen session), immediately after session

    Scale with 11 centimeters is used for evaluate pain intensity

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  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)

    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.

  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)

    During treatment, patients are asked about side effects resulting from the treatment performed.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Federal University of Paraíba

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jun 21, 2016
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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