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

Chronic Low Back Pain Clinical Trial

— COmEBACK  

Official title:

Effectiveness and Cost-effectiveness of the Pilates Method Versus Home-based Exercises in Individuals With Chronic Non-specific Low Back Pain: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113292
• Other study ID #: COmEBACK Trial
• Secondary ID: CAAE68870317.0.0
• Status: Completed
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: February 15, 2022

Study information

• Verified date: May 2022
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 15, 2022
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Pilates
The protocol will be composed by the following exercises, structured in each session according to progression, difficulty and focus (respiration, stability, muscle strength and joint mobility): Arm Arcs, Bent Knee Opening, Sidelying, Dead Bug, Femur Arcs, Quadruped Series, Single Leg Stretch, Prone Press Up, Sidekick (Front to Back 1 e 2), Leg Pull Front, Mermaid, Spine Stretch, The Hundred, Pelvic Clock, Bridging, Stanging Roll Down, Swan, Saw, Dart, Swimming, Book Opening. .
• Home Exercises
The protocol will be divided into 3 phases, each one composed by the following exercises and structured according to difficulty progression and focus (postural reeducation, muscle strength, balance, joint flexibility): Muscle strength exercises composed by abdominal exercises; back extension exercises; gluteus maximus exercises. Stretching exercises for the lower back, pelvis, iliopsoas muscle, tensor fascia latae muscle).

Locations

Country	Name	City	State
Brazil	Campus UnB Ceilândia	Brasília

Sponsors (1)

Lead Sponsor	Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensiy	Pain Intensity measured on a Visual Analog Scale (VAS, in centimeters)	Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Primary	Disability	Quebec Back Pain Disability Scale, scores ranging from 0 to 100	Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Secondary	Health status	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).	Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Secondary	Balance	Balance Platform, variation of the platform displacement	Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Secondary	Perception of Recovery	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")	Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)