Clinical trial NCT02807090: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Exercise
Dance Therapy
Physical Therapy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Federal University of Paraíba
First posted: 2016-06-21
Enrollment: 38
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pain through Pain visual analogue scale
timeFrame: 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 outcomes:
measure: Roland Morris Disability Questionnaire
timeFrame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
measure: Global Perceived Effect Scale
timeFrame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
measure: Beck Depression Inventory
timeFrame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
measure: Visual analogue scale for anxiety
timeFrame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
measure: Medical Outcomes Study 36 - Item Short - Form Health Survey
timeFrame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
measure: Symptoms and Adverse events or side effects
timeFrame: Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Juerila Moreira Barreto
state: Paraíba
Study officials:
affiliation: University of Sao Paulo
name: Raquel A Casarotto, PhD
role: STUDY_DIRECTOR
References: