Effects of the Pilates Method Versus Home Exercise in Individuals With Chronic Non-specific Back Pain

Not Applicable

Completed

• Conditions: Chronic Low Back Pain

• Registration Number: NCT03113292
• Lead Sponsor: University of Brasilia

Brief Summary

The aim is to compare the effectiveness and cost-effectiveness of a Pilates program versus home-based exercises in individuals with chronic non-specific low back pain. This is a randomized controlled trial with economic evaluation. Participants will be sequentially enrolled and randomly allocated into two groups: 1) Pilates: Mat Pilates sessions, supervised by a physiotherapist (2x/week for 6 weeks); 2) Home-Based Exercise: face-to-face familiarization (two sessions), supervised by another physiotherapist. After familiarization, the exercises will be prescribed using a booklet containing descriptions of sets/repetitions, as well as guidelines and precautions, to be performed during 6 weeks (2x/week) and monitored in a diary. Participants will be supervised by the physiotherapist (telephone/text messaging). Participants will be evaluated in three different moments: 1) Baseline (pre-intervention); 2) At the end of the intervention (post-intervention, 6 weeks); and 3) After six months follow-up (from post-intervention). Primary outcomes: pain intensity and disability. Secondary outcomes: perception of recovery, postural balance, and quality of life. Concurrently, a cost-effectiveness study will be conducted comparing the Pilates vs Home-Based Exercise, from the perspectives of public healthcare and society. In the first perspective, only costs incurred by the public healthcare system will be included (direct costs related to consultations, medications, tests, hospitalizations, and professional fees). In the second perspective, private health care expenses, costs incurred by patients (transportation and support by caregivers, when applicable), as well as indirect costs (missed workdays and loss of productivity) will be included. The incremental cost-effectiveness ratios for the primary outcomes and cost-utility ratios will be calculated for both perspectives. The cost-utility ratio will express the incremental costs per quality-adjusted life year (QALY). In addition, the absolute and incremental net monetary benefit will be calculated. Sensitivity analyses will be conducted. Data normality assumptions will be evaluated using the Shapiro Wilk test. If confirmed, a mixed model will be used, for the comparisons between groups and moments. It is hypothesized that the Pilates will be more cost-effective compared to the home-based exercise program.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-02
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-13
• Study Start: 2019-04-02
• Primary Completion: 2020-12-20
• Study Completion: 2022-02-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• Presence of chronic non-specific back pain for more than 12 consecutive weeks;
• Not having attended Pilates or physiotherapy sessions for at least 6 months prior to enrollment.

Exclusion Criteria

• History of trauma or fractures in the spine;;
• Diagnosis of osteoarthritis, disc herniation or spondylolisthesis;
• Referred pain (visceral, abdominoplasty, appendicitis, abdominal and pelvic surgeries);
• Previous surgery on the spine;
• Presence of root symptoms;
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensiy	Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)	Pain Intensity measured on a Visual Analog Scale (VAS, in centimeters)
Disability	Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)	Quebec Back Pain Disability Scale, scores ranging from 0 to 100

Secondary Outcome Measures

Name	Time	Method
Health status	Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)	Measure of health status by the EQ-5D-3L questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems).
Balance	Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)	Balance Platform, variation of the platform displacement
Perception of Recovery	Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)	Perception of Recovery measured by a Global Perceived Effect Scale (11-point scale), ranging from -5 ("much worse"), 0 ("no change"), to 5 ("completely recovered")

Trial Locations

Locations (1)

Campus UnB Ceilândia; 🇧🇷 Brasília, Brazil