NCT02807090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 6, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

May 18, 2016

Last Update Submit

August 5, 2019

Conditions

Keywords

Low Back PainExerciseDance TherapyPhysical Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Roland Morris Disability Questionnaire

    Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)

  • Global Perceived Effect Scale

    Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)

  • Beck Depression Inventory

    Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)

  • Visual analogue scale for anxiety

    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

    Before and after the treatment (immediately after the treatment, and 4 and 16 weeks after treatment)

  • +1 more secondary outcomes

Study Arms (2)

Lumbar Stabilization Exercise

EXPERIMENTAL

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

Circular Dance

EXPERIMENTAL

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

Interventions

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.

Lumbar Stabilization Exercise

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.

Circular Dance

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnose of non specific low back pain for a period of three months without radiculopathy symptoms
  • Seek treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juerila Moreira Barreto

João Pessoa, Paraíba, 58051900, Brazil

Location

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Raquel A Casarotto, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

June 21, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2018

Study Completion

January 1, 2019

Last Updated

August 6, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations