PTLBP: Pilates to Treat Low Back Pain

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01502059

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pain Quality of Life	Other: Pilates	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in pain [Baseline, after 45, 90 and 180 days]
Measured with the visual analogue scale ranging from 0 to 10

Secondary Outcome Measures

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