Effects of the Pilates Method Versus Home Exercise in Individuals With Chronic Non-specific Back Pain
- Conditions
- Chronic Low Back Pain
- Interventions
- Other: PilatesOther: Home Exercises
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- 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.
- 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
- Arm && Interventions
Group Intervention Description Pilates Method Pilates Mat Pilates Program, 2x/week, for 6 weeks, supervised by a Physiotherapist. Sessions will last forty five min, with 4 individuals per session. On average, 10 to 15 exercises will be performed per session, with repetitions ranging from 10 to 20 times, according subject's limitations. If necessary, the exercises will be adapted individually for the three levels of difficulty: basic, intermediate and advanced. Progress will be dependent on the absence of postural compensations when performing the repetitions of the exercises. Home Exercise Prescription Home Exercises Composed by two familiarization sessions, supervised by a Physiotherapist. The protocol include postural reeducation exercises, stretching and muscle strengthening, stabilization and mobilization of the spine. Subsequently, participants will receive an educational booklet containing information on low back pain, anatomy of the spine and its relation to the muscular chain, care during daily life activities and the importance of regular physical exercises. Also, it will include a booklet with the prescription of therapeutic home exercises to be performed during the next 6 weeks. It will be recommended that the participants perform the exercises 2x/week. Participants will also be contacted weekly by email and/or telephone, for remote supervision and for checking the prescribed exercises.
- 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