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

University of Brasilia

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Other: Home Exercises; Other: Pilates

Study type: Interventional

Funder types: Other

Identifiers

NCT03113292

CAAE68870317.0.0000.8093 (Other Identifier)

COmEBACK Trial

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

145 participants in 2 patient groups

Pilates Method

Experimental group

Description:

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.

Treatment:

Other: Pilates

Home Exercise Prescription

Active Comparator group

Description:

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.

Treatment:

Other: Home Exercises