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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807090
• Other study ID #: ELSE
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 2019

Study information

• Verified date: April 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Juerila Moreira Barreto	João Pessoa	Paraíba

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain through Pain visual analogue scale	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	Roland Morris Disability Questionnaire	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)
Secondary	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.	Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Secondary	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.	Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Secondary	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	Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Secondary	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.	Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Secondary	Symptoms and Adverse events or side effects	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)