Clinical trial NCT03113292: Effects of the Pilates Method Versus Home Exercise in Individuals With Chronic Non-specific Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: physical therapy
therapeutic exercises
low back pain
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled clinical trial, characterized by the application of therapeutic exercises, in which subjects will be randomly allocated into two groups: Pilates Method and Home-Based Exercises. The participantes will be individuals with non-specific chronic low back pain. The study will be reported following the recommendations of the CONSORT Statement. For the present study, chronic non-specific back pain was defined as uninterrupted low back pain for more than 12 weeks, with unknown causes.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensiy
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
measure: Disability
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Secondary outcomes:
measure: Health status
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
measure: Balance
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
measure: Perception of Recovery
timeFrame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Campus UnB Ceilândia
Study officials:
affiliation: University of Brasilia, School of Physical Therapy
name: Rodrigo L Carregaro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boff TA, Pasinato F, Ben AJ, Bosmans JE, van Tulder M, Carregaro RL. Effectiveness of spinal manipulation and myofascial release compared with spinal manipulation alone on health-related outcomes in individuals with non-specific low back pain: randomized controlled trial. Physiotherapy. 2020 Jun;107:71-80. doi: 10.1016/j.physio.2019.11.002. Epub 2019 Nov 18.