Clinical trial NCT01502059: Pilates to Treat Low Back Pain
Official title: The Effectiveness of Pilates to Treat Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Quality of Life
Keywords: Pilates
Exercise
Treatment
Low back pain
Pain
Function
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial, with blinded assessor to evaluate the effectiveness of Pilates to treat low back pain.

Hypothesis - the Pilates group will have best results than the control group (usual medicament treatment).

Detailed description: Background:

Low back pain (LBP) is a common problem among adults. Approximately 70-85% of the adult population experiences this painful complaint at some point in their lives, making LBP the second most common reason for a visit to a clinician. Despite the frequency of this diagnosis, conventional treatment does not always provide patients the desired results of reduced pain and return of normal function. For these patients, alternative modalities are available to assist in the control of pain. These options include chiropractic care, physical therapy, massage therapy, and modalities that fall under the auspices of complementary and alternative medicine, such as acupuncture. Unfortunately, Clinical trials evaluating the efficacy of a variety of interventions for chronic non-specific low back pain indicate limited effectiveness for most commonly applied interventions and approaches.

Objectives:

To evaluate the effectiveness of a mat and studio Pilates program on pain, function, quality of life and NHAI consumption for chronic non-specific low back pain patients.

Methods:

Eligible patient include: chronic non-specific low back pain; age between 18 and 65 years; pain ranging from 4 to 8 in a numerical pain scale. Patients with previous surgery, other causes of low back pain, fibromyalgia, regular physical activity (three or more times per week for at least three months); labor lawsuit and body mass index more than 30. Sixty patients were randomized to the Experimental Group (EG) or Control Group (CG). Patients in EG participated in 90 days of mat and studio Pilates program twice a week (50 minutes per class) and the CG remained with their usual medicament treatment and were included in a waiting list for physiotherapy. Assessment for pain (VAS), function (Roland Morris questionnaire), quality of life (SF-36) and NHAI consumption were done at baseline, after 45 days (T45), after 90 days (T90 - end of the program), after 90 days (T180 - follow up) by a blinded assessor.

Eligibility criteria: Inclusion Criteria:

* non specific mechanical low back pain
* visual analogue scale for pain ranging from 4 to 7

Exclusion Criteria:

* previous back surgery
* spinal tumor
* spinal fracture
* pregnancy
* fibromyalgia
* inflammatory or infectious spinal diseases
* litigant patients

Primary outcomes:
measure: Change in pain
timeFrame: Baseline, after 45, 90 and 180 days
Secondary outcomes:
measure: Change in function
timeFrame: Baseline, after 45, 90 and 180 days
measure: Change in quality of life
timeFrame: Baseline, after 45, 90 and 180 days
measure: Change in nonsteroidal antiinflammatory drugs (NSAIDs) consumption
timeFrame: Baseline, after 45, 90 and 180 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Anamaria Jones, PT
role: PRINCIPAL_INVESTIGATOR
References: