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Clinical Trials/NCT05047562
NCT05047562
Unknown
Not Applicable

Effect of Pilates Method and Segmental Stabilization in Elderly People With Chronic Non-specific Low Back Pain: Randomized Clinical Trial

University of Sao Paulo General Hospital1 site in 1 country60 target enrollmentJune 13, 2019
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
University of Sao Paulo General Hospital
Enrollment
60
Locations
1
Primary Endpoint
Change from baseline in functional disability on the Oswestry Disability Index at week 16, 3, and 6 months after the end of treatment
Last Updated
4 years ago

Overview

Brief Summary

INTRODUCTION: Low back pain is an important health condition with great consequences from the socioeconomic point of view and is associated with high costs for the health system, absenteeism at work and reduced functional performance. It is considered one of the most relevant health problems in the elderly, with point prevalence estimates higher than for other musculoskeletal conditions. It can be defined as any pain between the last ribs and the lower gluteal folds, with or without pain in the lower limbs, manifesting itself acutely, subacutely or chronically. OBJECTIVE: To compare the effect of the Pilates method versus segmental stabilization in elderly people with chronic low back pain. METHOD: 60 elderly people with chronic low back pain will participate in the study and will be randomized into two groups: Pilates Group (GP) and Segmental Stabilization Group (SG). The two treatments will have 16 individual sessions, twice a week. Pain will be assessed using the visual analogue pain scale; functional disability, using the Oswestry disability index; excessive fear of movement and physical activity, by the Tampa scale of kinesiophobia; level of confidence in the balance for specific activities, by the ABC scale and; activation of the transversus abdominis muscle by pressure biofeedback. Individuals will be evaluated in four moments: before the first session, after the last session, three and six months after the end of the treatment to verify the effects in the medium term. Patient allocation and assessments will be performed by a blind examiner. Data will be analyzed using the ANOVA procedure and Tukey's Multiple Comparison test. The significance level will be 5%. A hipótese deste estudo é que o grupo que realiza exercícios de Pilates obtém ganhos mais obtem que o grupo que realiza exercícios de estabilização segmentar em todas as variáveis ao final do tratamento.

Registry
clinicaltrials.gov
Start Date
June 13, 2019
End Date
March 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Non-specific low back pain for at least 3 months.
  • Intensity of pain equal to or greater than 3 cm.

Exclusion Criteria

  • Specific low back pain.
  • Neurological involvement (radiculopathy, myelopathy).
  • Previous spinal surgery.
  • Any impediment to performing the exercises.
  • Having had recent surgeries.
  • Being on treatment for low back pain
  • Not having cognitive ability to perform the exercises or be submitted to the proposed assessments
  • Missing appointments three times in a row.

Outcomes

Primary Outcomes

Change from baseline in functional disability on the Oswestry Disability Index at week 16, 3, and 6 months after the end of treatment

Time Frame: Baseline, week 16, 3 and 6 months after completion of treatment.

The Oswestry Disability Index is a validated instrument for the Portuguese language with high reliability for a Brazilian population. The index is calculated by adding the total score (each section is from 0 to 5) and the total points equal to the sum of the points of the 10 sections. Interpretation is performed by means of percentage: 0% to 20% minimal disability, 21% to 40% moderate disability, 41% to 60% severe disability, 61% to 80% disability, 81% to 100% patient bedridden or exaggerating symptoms.

Change from baseline in pain on the Numerical Pain Scale at week 16, 3 and 6 months after the end of treatment

Time Frame: Baseline, week 16, 3 and 6 months after completion of treatment.

The Numerical Pain Scale is a scale from 0 to 10, with 0 meaning total absence of pain and 10 the maximum bearable pain level by the patient. Change = Baseline, week 16, 3 and 6 months after the end of treatment.

Secondary Outcomes

  • Change from baseline to Kinesiophobia on the Tampa Kinesiophobia Scale at week 16, 3, and 6 months after the end of treatment.(Baseline, week 16, 3 and 6 months after completion of treatment.)
  • Change from baseline for confidence in balance to specific activities on the Activities-Specific Balance Confidence Scale at week 16, 3, and 6 months after the end of treatment.(Baseline, week 16, 3 and 6 months after completion of treatment.)
  • Change from baseline to transversus abdominis muscle activation in the pressure biofeedback unit at 16 weeks, 3 and 6 months after the end of treatment.(Baseline, week 16, 3 and 6 months after completion of treatment.)

Study Sites (1)

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