Pilates to Treat Low Back Pain (PTLBP)

The Effectiveness of Pilates to Treat Low Back Pain: A Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain
• Intervention / Treatment: Other: Pilates

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04329010
      • Universidade Federal de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pilates Group; This group keep their usual treatment and did a Pilates treatment twice a week (one hour each class) during 90 days.	Other: Pilates; Pilates training - twice a week (one hour per class) during 90 days
NO_INTERVENTION: Control Groups; This group keep their usual treatment and can do the Pilates training after the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	Measured with the visual analogue scale ranging from 0 to 10	Baseline, after 45, 90 and 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in function	Measured by the questionnaire Roland Morris	Baseline, after 45, 90 and 180 days
Change in quality of life	Measured by the SF-36 questionnaire	Baseline, after 45, 90 and 180 days
Change in nonsteroidal antiinflammatory drugs (NSAIDs) consumption	Measured by counting the number of tablets consumed per month	Baseline, after 45, 90 and 180 days

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: December 27, 2011
• First Submitted That Met QC Criteria: December 29, 2011
• First Posted (ESTIMATE): December 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 30, 2011
• Last Update Submitted That Met QC Criteria: December 29, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Treatment; Exercise; Pain; Low back pain; Function; Pilates
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CEP UNIFESP 0208/11